Review Panel
Immunology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,548
- Product Codes (page)
- 53
- Latest Decision
- 2018-04-20
Clearances · page 3 of 36
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | KTL | Class II | 2018-04-20 |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | KTL | Class II | 2018-04-20 |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | Phadia AB | DHB | Class II | 2018-04-16 |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | Immco Diagnostics, Inc. | NYO | Class II | 2018-03-30 |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | Aesku.Diagnostics GmbH & Co. KG | MOB | Class II | 2018-03-23 |
| K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | DFC | Class II | 2018-03-22 |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | Phadia AB | MOB | Class II | 2018-03-13 |
| K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | Phadia AB | OYL | Class II | 2018-03-02 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | The Binding Site Group , Ltd. | DCN | Class II | 2018-02-28 |
| K171605 | Elecsys CA 15-3 II | Roche Diagnostics | MOI | Class II | 2018-02-20 |
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Aesku.Diagnostics GmbH & Co. KG | LSW | Class II | 2018-02-16 |
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | The Binding Site Group , Ltd. | PCN | Class II | 2018-02-15 |
| DEN170045 | Banyan BTI | Banyan Biomarkers, Inc. | QAT | Class II | 2018-02-14 |
| K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | OIF | Class II | 2018-01-19 |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | DCN | Class II | 2018-01-12 |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Sebia | CFF | Class II | 2018-01-11 |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Inova Diagnostics, Inc. | NXO | Class II | 2017-12-22 |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | Siemens Healthcare Diagnostics Products GmbH | DFH | Class II | 2017-11-17 |
| K171868 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | PZH | Class II | 2017-11-11 |
| DEN170030 | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody | Ventana Medical Systems | PZJ | Class II | 2017-10-27 |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Inova Diagnostics, Inc. | NBS | Class II | 2017-09-06 |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Inova Diagnostics, Inc. | DBM | Class II | 2017-09-05 |
| K171642 | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | DBF | Class II | 2017-08-31 |
| K163367 | GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | PFX | Class II | 2017-08-11 |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | DBM | Class II | 2017-08-08 |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | Immco Diagnostics, Inc. | MST | Class II | 2017-07-28 |
| K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | DCK | Class II | 2017-07-14 |
| K170299 | Ion PGM Dx System | Life Technologies Corporation | PFF | Class II | 2017-06-22 |
| K170883 | FilmArray NGDS Warrior Panel | Biofire Defense, LLC | PRD | 2017-06-22 | |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | MSV | Class II | 2017-06-19 |
| K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | LTJ | Class II | 2017-05-17 |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | Phadia AB | DHB | Class II | 2017-05-05 |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | DHR | Class II | 2017-05-03 |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23AndMe, Inc. | PTA | Class II | 2017-04-06 |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | DCN | Class II | 2017-04-05 |
| DEN160048 | FilmArray NGDS Warrior Panel | Biofire Defense, LLC | PRD | 2017-02-14 | |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Inova Diagnostics, Inc. | MOB | Class II | 2017-02-03 |
| K161508 | Ceruloplasmin | Beckman Coulter Ireland, Inc. | DDB | Class II | 2017-01-09 |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | CFN | Class II | 2017-01-09 |
| K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | Sebia | CFF | Class II | 2016-12-21 |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | NUA | Class II | 2016-12-15 |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Luminex Molecular Diagnostics, Inc. | NUA | Class II | 2016-12-15 |
| K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | OVK | Class II | 2016-12-14 |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | DHR | Class II | 2016-12-07 |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator | Diazyme Laboratories | DFH | Class II | 2016-11-18 |
| K160447 | Calprest NG | Eurospital S.P.A. | NXO | Class II | 2016-11-10 |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | The Binding Site Group , Ltd. | PCN | Class II | 2016-10-04 |
| K151589 | BD MAX CT/GC/TV, BD MAX INSTRUMENT | Becton, Dickinson and Company | OUY | Class II | 2016-09-06 |
| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid | OUY | Class II | 2016-08-29 |
| K153560 | Optilite Low Level Albumin Kit | The Binding Site Group , Ltd. | DCF | Class II | 2016-08-25 |
| K161182 | Solana Trichomonas Assay | Quidel Corporation | OUY | Class II | 2016-08-15 |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | Axis-Shield Diagnostics Limited | NHX | Class II | 2016-08-04 |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | Phadia AB | DGC | Class II | 2016-07-28 |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | Aesku Systems GmbH&Co.Kg | DHN | Class II | 2016-07-28 |
| K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | PNI | Class II | 2016-07-22 |
| K160265 | Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | DHN | Class II | 2016-06-17 |
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | The Binding Site Group , Ltd. | OPX | Class II | 2016-06-16 |
| K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | JZG | Class II | 2016-06-07 |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Inova Diagnostics, Inc. | LLL | Class II | 2016-06-01 |
| DEN150030 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | PNI | Class II | 2016-04-25 |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Inova Diagnostics, Inc. | LSW | Class II | 2016-04-11 |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | Phadia AB | JZO | Class II | 2016-03-25 |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Immco Diagnostics, Inc. | LJM | Class II | 2016-03-11 |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument | Orion Diagnostica, OY | DCK | Class II | 2016-03-10 |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | JZO | Class II | 2016-03-03 |
| K150597 | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | Phadia AB | DHB | Class II | 2016-02-29 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Inova Diagnostics, Inc. | LLL | Class II | 2016-02-12 |
| K151029 | Phadia Prime | Phadia AB | DHB | Class II | 2016-01-19 |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | Inova Diagnostics, Inc. | MSV | Class II | 2015-12-21 |
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | The Binding Site Group , Ltd. | PDE | Class II | 2015-12-18 |
| K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut | Phadia AB | DHB | Class II | 2015-12-14 |
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | Inova Diagnostics, Inc. | PIV | Class II | 2015-11-24 |
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Fujirebio Diagnostics,Inc. | OIU | Class II | 2015-11-24 |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | The Binding Site Group , Ltd. | OPX | Class II | 2015-11-06 |
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit | Cepheid | OUY | Class II | 2015-10-16 |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | DCK | Class II | 2015-09-24 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | Immco Diagnostics, Inc. | DHR | Class II | 2015-09-23 |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Inova Diagnostics, Inc. | NHX | Class II | 2015-09-21 |
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | The Binding Site Group , Ltd. | DAE | Class II | 2015-08-28 |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | The Binding Site Group , Ltd. | DFH | Class II | 2015-08-26 |
| K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | LTK | Class II | 2015-08-06 |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | CFN | Class II | 2015-05-30 |
| K143118 | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group , Ltd. | DCF | Class II | 2015-05-26 |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | Fujirebio Diagnostics,Inc. | LTK | Class II | 2015-05-21 |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | Euroimmun Us, Inc. | DHN | Class II | 2015-04-17 |
| DEN140039 | NOVA View Automated Fluorescense Microscope | Inova Diagnostics, Inc. | PIV | Class II | 2015-04-09 |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | DHN | Class II | 2015-04-08 |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | Immco Diagnostics, Inc. | LLL | Class II | 2015-03-31 |
| K143329 | AmpliVue Trichomonas Assay | Quidel Corporation | OUY | Class II | 2015-03-17 |
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | Inova Diagnostics, Inc. | OBE | Class II | 2015-03-05 |
| DEN140044 | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | 23AndMe | PKB | Class II | 2015-02-19 |
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Phadia US, Inc. | DBM | Class II | 2015-02-13 |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. | Inova Diagnostics, Inc. | MSV | Class II | 2015-02-13 |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | Inova Diagnostics, Inc. | LLL | Class II | 2015-02-12 |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | Inova Diagnostics, Inc. | LLL | Class II | 2015-01-29 |
| K141142 | MAMMAPRINT FFPE | Agendia | NYI | Class II | 2015-01-23 |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia | CFF | Class II | 2015-01-08 |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit | Qualigen, Inc. | DCK | Class II | 2015-01-07 |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | CFN | Class II | 2014-12-21 |
| DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | Wallac OY | PJI | Class II | 2014-12-15 |
3,548 clearances in the Immunology panel. Data: openFDA.