Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DER — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
276 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013249 | TINA-QUANT APOLIPOPROTEIN VER.2 | Roche Diagnostics Corp. | 2001-11-16 | 49 | 0 |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | 2000-05-18 | 57 | 0 |
| K993354 | K-ASSAY APO B | Kamiya Biomedical Co. | 1999-10-28 | 23 | 0 |
| K993345 | K-ASSAY APO AI | Kamiya Biomedical Co. | 1999-10-25 | 20 | 0 |
| K990594 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Roche Diagnostics Corp. | 1999-04-14 | 49 | 0 |
| K983289 | APOLIPOPROTEIN A1 | Abbott Laboratories | 1999-01-29 | 133 | 1 |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | 1997-08-01 | 276 | 0 |
| K964296 | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 | 276 | 0 |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 | 276 | 0 |
| K910553 | ROCHE APOLIPOPROTEIN STANDARD | Roche Diagnostic Systems, Inc. | 1991-05-08 | 90 | 0 |
| K904125 | UC IMU A | Eucardio Laboratory, Inc. | 1990-09-24 | 18 | 0 |
| K872078 | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Solomon Park Research Laboratories | 1987-06-18 | 20 | 0 |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | 1986-01-24 | 51 | 0 |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Photec Diagnostics, Inc. | 1985-08-28 | 40 | 0 |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | 1985-06-05 | 44 | 0 |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | Ventrex Laboratories, Inc. | 1984-05-21 | 87 | 0 |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Hyland Therapeutic Div., Travenol Laboratories | 1981-01-05 | 76 | 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