Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Immunology — Predicate Candidate Screening
3,537 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
102 daysmedian FDA review time
329 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026-08-07 | 102 | 0 |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (G | Hycor Biomedical | 2026-07-24 | 116 | 0 |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed | Hycor Biomedical | 2026-07-21 | 148 | 0 |
| K253367 | EliA CTD 13 Screen | Phadia AB | 2026-06-25 | 268 | 0 |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Tri | Hycor Biomedical | 2026-06-18 | 140 | 0 |
| K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | 2026-06-16 | 266 | 0 |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut | Hycor Biomedical | 2026-05-15 | 127 | 0 |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SS | Zeus Scientific | 2026-05-08 | 417 | 0 |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026-04-02 | 87 | 0 |
| K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | 2026-03-30 | 17 | 0 |
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026-02-06 | 410 | 0 |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Ar | Hycor Biomedical | 2026-01-16 | 136 | 0 |
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 | 222 | 0 |
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Contr | DiaSorin, Inc. | 2025-12-23 | 146 | 0 |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Sh | Hycor Biomedical | 2025-12-23 | 137 | 0 |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Huma | Diazyme Laboratories, Inc. | 2025-12-19 | 80 | 0 |
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025-12-16 | 264 | 0 |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 | 261 | 0 |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | 2025-10-22 | 231 | 0 |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 | 262 | 0 |
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT | The Binding Site Group , Ltd. | 2025-10-17 | 269 | 1 |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | 2025-10-08 | 90 | 0 |
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | 2025-09-30 | 91 | 0 |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | 2025-09-19 | 218 | 0 |
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 | 267 | 0 |
| DEN240032 | APO-Easy Genotyping kit | Firalis SA | 2025-06-12 | 356 | 0 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx | The Binding Site Group , Ltd. | 2025-05-23 | 87 | 0 |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | 2025-05-16 | 249 | 7 |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti | Zeus Scientific | 2025-05-07 | 149 | 0 |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, John | Hycor Biomedical | 2025-04-23 | 240 | 0 |
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | 2025-04-18 | 268 | 0 |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | 2025-01-24 | 268 | 0 |
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | 2025-01-07 | 230 | 0 |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024-12-17 | 809 | 0 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024-08-09 | 171 | 0 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024-07-03 | 83 | 0 |
| K240987 | Access sTfR | Beckman Coulter, Inc. | 2024-07-03 | 84 | 0 |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-28 | 85 | 0 |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-07 | 18 | 0 |
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024-05-31 | 403 | 0 |
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | 2024-05-10 | 80 | 0 |
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024-05-09 | 90 | 0 |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | 2024-05-01 | 90 | 0 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024-03-27 | 89 | 0 |
| K234052 | Access Ferritin | Beckman Coulter, Inc. | 2024-03-20 | 90 | 0 |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 | 90 | 0 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level | Sebia | 2024-02-23 | 267 | 0 |
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024-02-06 | 210 | 0 |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lamb | The Binding Site, Ltd. | 2024-01-24 | 265 | 0 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda