Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JNL · Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
241 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 | 261 | 0 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024-07-03 | 83 | 0 |
| K112933 | ACCESS THYROGLOBULIN ANITBODY | Beckman Coulter, Inc. | 2011-12-27 | 85 | 2 |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | Phadia US, Inc. | 2007-11-20 | 60 | 0 |
| K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGE | Beckman Coulter, Inc. | 2006-10-05 | 38 | 2 |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Monobind | 1997-07-03 | 45 | 0 |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K954256 | ANTI-TPO | Biomerica, Inc. | 1995-11-27 | 83 | 0 |
| K951362 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 | 241 | 0 |
| K951364 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 | 241 | 0 |
| K951320 | AURAFLEX TG-AB AND TPO-AB | Organon Teknika Corp. | 1995-08-25 | 155 | 0 |
| K952607 | AURAFLEX TPO-AB | Organon Teknika Corp. | 1995-08-25 | 86 | 0 |
| K943580 | AUTOSTAT II ANTI-TPO | Cogent Diagnotics , Ltd. | 1995-04-17 | 269 | 0 |
| K941361 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 | 51 | 0 |
| K941358 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 | 51 | 0 |
| K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT | Nichols Institute | 1993-04-08 | 51 | 0 |
| K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL | Cogent Diagnotics , Ltd. | 1992-09-22 | 75 | 0 |
| K923370 | AUTOSTAT ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1992-09-22 | 75 | 0 |
| K921787 | SYNELISA TPO ANTIBODIES | Elias U.S.A., Inc. | 1992-07-28 | 105 | 0 |
| K905486 | IMMUNOWELL TPO (MICROSOME) TEST | General Biometrics, Inc. | 1991-01-03 | 28 | 0 |
| K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL | General Biometrics, Inc. | 1990-10-02 | 42 | 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