Review Panel
Immunology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,548
- Product Codes (page)
- 49
- Latest Decision
- 2022-09-08
Clearances · page 2 of 36
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | 2022-09-08 |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | 2022-08-04 |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed | Phadia AB | DHB | Class II | 2022-08-03 |
| K202852 | DiviTum TKa | Biovica International AB | QTE | Class II | 2022-07-29 |
| K210902 | EliA Ro52, EliA Ro60 | Phadia AB | LKJ | Class II | 2022-07-27 |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | NXO | Class II | 2022-07-26 |
| K213626 | VITROS AFP | Ortho Clinical Diagnostics | LOJ | Class II | 2022-06-15 |
| DEN200062 | Parsortix PC1 Device | Angle Europe , Ltd. | QSA | Class II | 2022-05-24 |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | QSE | Class II | 2022-05-04 |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific, Inc. | DHN | Class II | 2022-04-29 |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | DGC | Class II | 2022-03-23 |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | DFH | Class II | 2022-03-02 |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | Hycor Biomedical | DHB | Class II | 2022-02-18 |
| K203184 | HYDRASHIFT 2/4 isatuximab | Sebia | CFF | Class II | 2021-11-12 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | DFH | Class II | 2021-10-29 |
| K193613 | Allergen-Specific IgE Assay 12 Allergen Bundle | Hitachi Chemical Diagnostics, Inc. | DHB | Class II | 2021-10-18 |
| K193650 | LIAISON Ferritin | DiaSorin, Inc. | DBF | Class II | 2021-09-14 |
| K202541 | EliA RNA Pol III | Phadia AB | NYO | Class II | 2021-09-13 |
| K202540 | EliA Rib-P | Phadia AB | MQA | Class II | 2021-09-13 |
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | MVM | Class II | 2021-08-26 |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | NOE | Class II | 2021-08-06 |
| K200129 | OncoMate MSI Dx Analysis System | Promega Corporation | PZJ | Class II | 2021-07-26 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | DFH | Class II | 2021-07-14 |
| K202067 | EliA SmDP-S | Phadia AB | LKP | Class II | 2021-07-14 |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | MVM | Class II | 2021-06-16 |
| K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | PZH | Class II | 2021-05-13 |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Abbott Laboratories | QAT | Class II | 2021-01-08 |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimers disease | Helix Opco, LLC | PTA | Class II | 2020-12-23 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | KTL | Class II | 2020-12-11 |
| K201902 | MammaPrint | Agendia, Inc. | NYI | Class II | 2020-11-05 |
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | Euroimmun Us, Inc. | OEG | Class II | 2020-09-17 |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | MOI | Class II | 2020-09-04 |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | PTA | Class II | 2020-08-13 |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | CZP | Class II | 2020-06-26 |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense | Hycor Biomedical | DHB | Class II | 2020-06-26 |
| K192028 | Yumizen C1200 CRP | HORIBA ABX SAS | DCK | Class II | 2020-06-25 |
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company | DHR | Class II | 2020-05-20 |
| K200997 | Lumipulse G CA19-9-N | Fujirebio Diagnostics,Inc. | NIG | Class II | 2020-05-14 |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | Phadia AB | DHB | Class II | 2020-05-01 |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | DHX | Class II | 2020-04-13 |
| K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | LTK | Class II | 2020-04-06 |
| K190495 | Transferrin | Biosystems S.A. | DDG | Class II | 2020-03-16 |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | HORIBA ABX SAS | DBF | Class II | 2020-03-06 |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | JZO | Class II | 2020-02-27 |
| DEN190023 | AmplideX Fragile X Dx & Carrier Screen Kit | Asuragen, Inc. | OYV | Class II | 2020-02-21 |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | DCN | Class II | 2020-02-21 |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | MOI | Class II | 2020-02-13 |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | DGC | Class II | 2020-01-15 |
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | LLL | Class II | 2019-11-29 |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | MOI | Class II | 2019-11-22 |
| K192118 | CRP Vario | SENTINEL CH. SpA | DCK | Class II | 2019-11-08 |
| K192858 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | PZH | Class II | 2019-11-05 |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | CFF | Class II | 2019-11-01 |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | ALPCO | NXO | Class II | 2019-10-25 |
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. | LKO | Class II | 2019-10-25 |
| K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | NIG | Class II | 2019-10-22 |
| K191993 | Yumizen C1200 CRP | HORIBA ABX SAS | DCK | Class II | 2019-10-03 |
| K183462 | Applied Biosystems Bacillus anthracis Detection Kit | Mriglobal | QIF | 2019-10-01 | |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | NXO | Class II | 2019-09-24 |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | CFN | Class II | 2019-09-04 |
| K191985 | Optilite IgA Kit | The Binding Site Group , Ltd. | CFN | Class II | 2019-08-19 |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae | Hycor Biomedical | DHB | Class II | 2019-07-31 |
| K191635 | Optilite IgM Kit | The Binding Site Group , Ltd. | CFN | Class II | 2019-07-15 |
| K191589 | Calprest, EasyCal | Eurospital S.P.A. | NXO | Class II | 2019-07-10 |
| K191592 | CalprestNG, EasyCal | Eurospital S.P.A. | NXO | Class II | 2019-07-10 |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | CFN | Class II | 2019-06-27 |
| K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | NXO | Class II | 2019-06-25 |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | CFN | Class II | 2019-05-28 |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | Phadia AB | DHB | Class II | 2019-05-14 |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | DFH | Class II | 2019-05-03 |
| K190851 | HYDRASHIFT 2/4 daratumumab | Sebia | CFF | Class II | 2019-05-02 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | DHR | Class II | 2019-04-17 |
| K182793 | AP3600 Automated Instrument | Hitachi Chemical Diagnostics, Inc. | DHB | Class II | 2019-03-19 |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Phadia AB | MVM | Class II | 2019-03-01 |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | Euroimmun Us, Inc. | MVM | Class II | 2019-02-28 |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | CFN | Class II | 2019-01-23 |
| K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | OUY | Class II | 2019-01-08 |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | DiaSorin, Inc. | NXO | Class II | 2018-12-26 |
| K183007 | EliA SmDP Immunoassay | Phadia AB | LKP | Class II | 2018-12-24 |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | DHR | Class II | 2018-12-18 |
| K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus | Hycor Biomedical | DHB | Class II | 2018-12-04 |
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | Phadia AB | LJM | Class II | 2018-11-27 |
| K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | Kronus, Inc. | PCG | Class II | 2018-11-23 |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | DDG | Class II | 2018-11-05 |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH | DFH | Class II | 2018-11-01 |
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | DBL | Class II | 2018-10-19 |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | NXO | Class II | 2018-10-16 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | DCN | Class II | 2018-10-12 |
| K173833 | CRP Vario | SENTINEL CH. SpA | NQD | Class II | 2018-09-27 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | DFH | Class II | 2018-08-23 |
| K181556 | EliA M2 Immunoassay | Phadia AB | DBM | Class II | 2018-07-13 |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | 2018-06-26 |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | LLL | Class II | 2018-06-25 |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | MSV | Class II | 2018-06-25 |
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | SEKISUI Diagnostics, LLC | KTN | Class II | 2018-06-22 |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics | MOI | Class II | 2018-06-22 |
| K172745 | ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. | DHN | Class II | 2018-06-05 |
| K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | NXO | Class II | 2018-06-04 |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | Euroimmun Us, Inc. | MOB | Class II | 2018-05-24 |
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | DEH | Class II | 2018-05-08 |
3,548 clearances in the Immunology panel. Data: openFDA.