Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JLW — Predicate Candidate Screening
242 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
209 days90th percentile
242clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 | 262 | 0 |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cart | Siemens Healthcare Diagnostics | 2025-04-25 | 158 | 0 |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | 2024-07-22 | 209 | 0 |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 | 192 | 0 |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormo | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 | 360 | 1 |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analy | Beckman Coulter, Inc. | 2022-11-10 | 196 | 18 |
| K190773 | Elecsys TSH | Roche Diagnostics | 2019-04-16 | 21 | 0 |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB | Boditech Med, Inc. | 2017-10-13 | 261 | 0 |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | 2017-07-28 | 106 | 0 |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017-07-14 | 290 | 0 |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | 2017-01-23 | 126 | 0 |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit | Sysmex America, Inc. | 2016-10-21 | 238 | 0 |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrator | Beckman Coulter, Inc. | 2016-08-18 | 241 | 0 |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2016-05-31 | 85 | 0 |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinida | Siemens Healthcare Diagnostics, Inc. | 2015-11-20 | 142 | 2 |
| K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | 2015-05-01 | 72 | 0 |
| K141999 | ADVIA CENTAUR TSH | Siemens Healthcare Diagnostics, Inc. | 2015-04-22 | 273 | 1 |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | Nanoentek USA, Inc. | 2014-03-14 | 260 | 0 |
| K130469 | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYR | DiaSorin, Inc. | 2013-04-05 | 39 | 0 |
| K110761 | MICT TSH | Magnabiosciences, LLC | 2012-03-09 | 357 | 0 |
| K101390 | FASTPACK TSH IMMUNOASSAY | Qualigen, Inc. | 2010-08-13 | 88 | 0 |
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | Perkinelmer, Inc. | 2009-09-03 | 157 | 4 |
| K083844 | ADVIA CENTAUR TSH3-ULTRA METHOD | Siemens Healthcare Diagnostics | 2009-05-08 | 135 | 4 |
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBR | Ortho-Clinical Diagnostics | 2008-12-22 | 56 | 16 |
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBR | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 | 143 | 26 |
| K081074 | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 | 37 | 3 |
| K072458 | GBI TSH NEONATAL SCREENING KIT | Golden Bridge International, Inc. | 2008-04-10 | 223 | 0 |
| K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | Monobind, Inc. | 2008-04-04 | 507 | 0 |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMU | Olympus America, Inc. | 2006-11-29 | 90 | 0 |
| K060090 | DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CAR | Dade Behring, Inc. | 2006-02-27 | 46 | 1 |
| K052301 | FASTPACK TSH IMMUNOASSAY | Qualigen, Inc. | 2006-01-04 | 135 | 1 |
| K042281 | MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY | Beckman Coulter, Inc. | 2004-09-16 | 23 | 0 |
| K041014 | TSH-CTK-3 IRMA | DiaSorin, Inc. | 2004-07-14 | 85 | 0 |
| K030912 | THYRO TEST | Thryotec | 2003-07-25 | 123 | 1 |
| K023093 | ACCESS HYPERSENSITIVE HTSH ASSAY | Beckman Coulter, Inc. | 2002-11-25 | 68 | 0 |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | Awareness Technology, Inc. | 2002-07-19 | 277 | 0 |
| K011527 | PRAXSYS RELIA TSH TEST | Praxsys Biosystems, Inc. | 2001-08-07 | 82 | 0 |
| K011525 | SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTI | Biosafe Laboratories, Inc. | 2001-07-16 | 60 | 0 |
| K003752 | BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID | Biosafe Laboratories, Inc. | 2001-03-23 | 108 | 0 |
| K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | Neometrics, Inc. | 2000-11-02 | 177 | 0 |
| K001606 | REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) | Repromedix Corp. | 2000-10-05 | 134 | 0 |
| K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | Biocheck, Inc. | 1999-06-22 | 78 | 0 |
| K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; | Biocheck, Inc. | 1999-06-22 | 90 | 0 |
| K990658 | THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY | Little Nell Labs, Inc. | 1999-06-02 | 93 | 0 |
| K983442 | ABBOTT ARCHITECT TSH | Abbott Laboratories | 1998-11-20 | 51 | 0 |
| K981312 | 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1998-06-05 | 56 | 0 |
| K981060 | ABBOTT AXSYM 3RD GENERATION TSH ASSAY | Abbott Laboratories | 1998-04-29 | 37 | 0 |
| K980574 | AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TS | Alfa Biotech (Uk) , Ltd. | 1998-03-24 | 35 | 0 |
| K973276 | AUTODELFIA NEONATAL HTSH L KIT (B077-112) | Eg &G Wallac | 1997-11-20 | 79 | 0 |
| K972586 | AIA-PACK TSH 3RD-GEN ASSAY | Tosoh Medics, Inc. | 1997-08-29 | 49 | 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