Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CHH — Predicate Candidate Screening
230 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
196 days90th percentile
230clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251091 | Lipids | Truvian Health | 2025-12-30 | 264 | 0 |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDE | Medicon Hellas S.A | 2024-08-09 | 365 | 0 |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | 2022-06-30 | 568 | 0 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 | 27 | 0 |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018-10-18 | 147 | 0 |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | 2018-03-28 | 30 | 0 |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol P | ACON Laboratories, Inc. | 2017-07-11 | 218 | 0 |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, Ca | Polymer Technology Systems, Inc. | 2016-12-22 | 562 | 0 |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | 2015-09-29 | 200 | 0 |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | 2014-03-21 | 246 | 0 |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2013-02-15 | 18 | 0 |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 | 28 | 0 |
| K120202 | EON CHOLESTEROL REAGENT | Vital Diagnostics Pty., Ltd. | 2012-07-27 | 186 | 0 |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 | 242 | 0 |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-03-29 | 210 | 0 |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLE | Hitachi Chemical Diagnostics, Inc. | 2011-12-14 | 175 | 0 |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTER | Alfa Wassermann, Inc. | 2009-10-26 | 166 | 0 |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, | Jas Diagnostics, Inc. | 2008-11-17 | 257 | 0 |
| K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | Medica Corp. | 2008-02-20 | 191 | 1 |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-10-15 | 126 | 1 |
| K062026 | VAP-NT CHOLESTEROL TEST | Atherotech, Inc. | 2007-03-06 | 231 | 0 |
| K051376 | ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT | Roche Diagnostics | 2005-08-23 | 89 | 0 |
| K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TES | Arkray, Inc. | 2004-11-24 | 76 | 0 |
| K031824 | COBAS INTEGRA CHOLESTEROL GEN. 2 | Roche Diagnostics Corp. | 2003-07-09 | 26 | 1 |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | Abaxis, Inc. | 2003-01-24 | 86 | 0 |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-11-15 | 23 | 1 |
| K022898 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-09-24 | 21 | 1 |
| K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2001-10-22 | 28 | 0 |
| K011970 | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT S | Biosafe Laboratories, Inc. | 2001-09-26 | 93 | 0 |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 2000-07-24 | 116 | 0 |
| K000610 | RESOLUTION CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | 2000-07-21 | 149 | 0 |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | Elan Holdings, Inc. | 2000-05-02 | 42 | 0 |
| K993096 | PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL M | Lifestream Technologies, Inc. | 1999-12-20 | 206 | 0 |
| K992803 | SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-2 | Sigma Diagnostics, Inc. | 1999-09-13 | 25 | 0 |
| K992132 | CHOLESITE TEST SYSTEM | Gds Technology, LLC | 1999-08-20 | 58 | 0 |
| K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 1999-08-20 | 142 | 0 |
| K990688 | MTM BIOSCANNER C TEST STRIPS | Polymer Technology Systems, Inc. | 1999-06-24 | 119 | 1 |
| K981345 | CHOLESTRON PRO II CHOLESTEROL TEST | Lifestream Diagnostics, Inc. | 1998-10-01 | 170 | 0 |
| K982469 | HICHEM CHOLESTEROL REAGENT KIT | Elan Pharma, Inc. | 1998-08-19 | 35 | 0 |
| K981181 | ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIR | Actimed Laboratories, Inc. | 1998-08-03 | 124 | 0 |
| K982118 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | 1998-07-24 | 51 | 0 |
| K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, | Polymer Technology Systems, Inc. | 1998-07-22 | 86 | 1 |
| K981652 | CHOL | Abbott Laboratories | 1998-06-29 | 49 | 0 |
| K981476 | CHOL | Abbott Laboratories | 1998-06-25 | 62 | 0 |
| K980667 | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) | Sigma Diagnostics, Inc. | 1998-04-21 | 60 | 0 |
| K973284 | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | Roche Diagnostic Systems, Inc. | 1997-12-18 | 107 | 0 |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Reagents Applications, Inc. | 1997-09-24 | 89 | 0 |
| K971072 | CHOLESTEROL REAGENT | Derma Media Lab., Inc. | 1997-06-20 | 88 | 0 |
| K971505 | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT | Beckman Instruments, Inc. | 1997-06-11 | 47 | 0 |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Dade Intl., Inc. | 1997-06-04 | 196 | 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