Review Panel
Immunology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,548
- Product Codes (page)
- 48
- Latest Decision
- 2026-09-30
Clearances · page 1 of 36
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K262893 | Eonis SMA kit | Revvity, Inc. | QUE | Class II | 2026-09-30 |
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | DHB | Class II | 2026-09-04 |
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | MOB | Class II | 2026-08-21 |
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | LLL | Class II | 2026-08-21 |
| K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | SET | Class II | 2026-08-19 |
| K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | SET | Class II | 2026-08-19 |
| K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | NIG | Class II | 2026-08-10 |
| K261362 | Xpert Hemorrhagic Fever | Cepheid | QVR | Class II | 2026-08-07 |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | Hycor Biomedical | DHB | Class II | 2026-07-24 |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | Hycor Biomedical | DHB | Class II | 2026-07-21 |
| K253367 | EliA CTD 13 Screen | Phadia AB | LLL | Class II | 2026-06-25 |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical | DHB | Class II | 2026-06-18 |
| K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | DFC | Class II | 2026-06-16 |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | Hycor Biomedical | DHB | Class II | 2026-05-15 |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific | OBE | Class II | 2026-05-08 |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | NQD | Class II | 2026-04-02 |
| K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | SGA | Class II | 2026-03-30 |
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | MSV | Class II | 2026-02-06 |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | Hycor Biomedical | DHB | Class II | 2026-01-16 |
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | LTJ | Class II | 2026-01-05 |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical | DHB | Class II | 2025-12-23 |
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | DiaSorin, Inc. | SGW | Class II | 2025-12-23 |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | 2025-12-19 |
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | OVK | Class II | 2025-12-16 |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | JNL | Class II | 2025-12-04 |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | LLL | Class II | 2025-10-22 |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | JZO | Class II | 2025-10-17 |
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | SGG | Class II | 2025-10-17 |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | SET | Class II | 2025-10-08 |
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | SGA | Class II | 2025-09-30 |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | LLL | Class II | 2025-09-19 |
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | MSW | Class II | 2025-06-20 |
| DEN240032 | APO-Easy Genotyping kit | Firalis SA | SFC | Class II | 2025-06-12 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | DFH | Class II | 2025-05-23 |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | SET | Class II | 2025-05-16 |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific | MOB | Class II | 2025-05-07 |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | Hycor Biomedical | DHB | Class II | 2025-04-23 |
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | DCK | Class II | 2025-04-18 |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | Biofire Defense, LLC | PRD | 2025-03-12 | |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | DFC | Class II | 2025-01-24 |
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | PTA | Class II | 2025-01-07 |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | MID | Class II | 2024-12-17 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | JZO | Class II | 2024-08-09 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | JNL | Class II | 2024-07-03 |
| K240987 | Access sTfR | Beckman Coulter, Inc. | DDG | Class II | 2024-07-03 |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | MSW | Class II | 2024-06-28 |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | MSW | Class II | 2024-06-07 |
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | DGC | Class II | 2024-05-31 |
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | LTK | Class II | 2024-05-10 |
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | MOI | Class II | 2024-05-09 |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | QAT | Class II | 2024-05-01 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | QAT | Class II | 2024-03-27 |
| K234052 | Access Ferritin | Beckman Coulter, Inc. | JMG | Class II | 2024-03-20 |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | MOI | Class II | 2024-03-13 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia | DFH | Class II | 2024-02-23 |
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | NXO | Class II | 2024-02-06 |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site, Ltd. | DFH | Class II | 2024-01-24 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | NQD | Class II | 2024-01-18 |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | CFN | Class II | 2023-12-13 |
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | DCN | Class II | 2023-11-27 |
| K231316 | Aptima Trichomonas vaginalis Assay | Hologic, Inc. | OUY | Class II | 2023-11-06 |
| DEN220090 | EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | Stemcell Technologies Canada, Inc. | QYO | Class II | 2023-11-06 |
| K221890 | Elecsys Tg II | Roche Diagnostics | MSW | Class II | 2023-09-30 |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | LLL | Class II | 2023-09-29 |
| K232669 | TBI | Abbott Laboratories | QAT | Class II | 2023-09-29 |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | JZO | Class II | 2023-09-26 |
| K223921 | Access CEA | Beckman Coulter, Inc. | DHX | Class II | 2023-09-22 |
| K231832 | Access Myoglobin | Beckman Coulter, Inc. | DDR | Class II | 2023-09-18 |
| K222251 | B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | B.R.A.H.M.S GmbH, Part of Thermo Fisher | QXS | Class II | 2023-09-18 |
| K231336 | T2 Biothreat Panel | T2biosystems, Inc. | QVR | Class II | 2023-09-15 |
| K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | MSW | Class II | 2023-09-15 |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | JZO | Class II | 2023-09-15 |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | LTK | Class II | 2023-09-08 |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific | KTL | Class II | 2023-08-31 |
| K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | OIF | Class II | 2023-08-24 |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | DHX | Class II | 2023-08-23 |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics | NIG | Class II | 2023-08-09 |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | CFN | Class II | 2023-08-02 |
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | Roche Diagnostics | QSE | Class II | 2023-06-05 |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | Immuno Concepts, N.A. , Ltd. | KTL | Class II | 2023-05-26 |
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix , Ltd. | MMW | Class II | 2023-05-04 |
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | ALPCO | NXO | Class II | 2023-04-13 |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | Biofire Defense, LLC | QVR | Class II | 2023-03-22 |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | DCN | Class II | 2023-03-17 |
| K223602 | Traumatic brain injury (TBI) test | Abbott Laboratories | QAT | Class II | 2023-03-02 |
| K211181 | Idylla MSI Test | Biocartis NV | PZJ | Class II | 2023-02-27 |
| K214068 | Quantia IgE | Biokit, S.A. | DGC | Class II | 2023-02-21 |
| K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle, Ltd. | PZJ | Class II | 2023-02-21 |
| K211058 | Lp(a) Ultra | SENTINEL CH. SpA | DFC | Class II | 2022-12-22 |
| K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | NQD | Class II | 2022-12-16 |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho Clinical Diagnostics | LTK | Class II | 2022-12-12 |
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | Roche Diagnostics | QSE | Class II | 2022-12-07 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Sebia | DFH | Class II | 2022-11-18 |
| DEN200044 | Eonis SCID-SMA Kit | Perkinelmer, Inc. | QUE | Class II | 2022-11-09 |
| K203035 | Eonis SCID-SMA kit | Perkinelmer, Inc. | PJI | Class II | 2022-11-09 |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | Procise Diagnostics | DCK | Class II | 2022-11-04 |
| K221420 | AlphaID At Home Genetic Health Risk Service | Progenika Biopharma S.A., A Grifols Company | PTA | Class II | 2022-10-27 |
| K213396 | SPIFE A1AT kit | Helena Laboratories, Corp. | OBZ | Class II | 2022-10-13 |
| K220176 | Elecsys AFP | Roche Diagnostics | LOJ | Class II | 2022-09-15 |
| K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | NYI | Class II | 2022-09-08 |
3,548 clearances in the Immunology panel. Data: openFDA.