Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LBS — Predicate Candidate Screening
80 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
183 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162593 | HDL-Cholesterol Gen.4 | Roche Diagnostics Operations (Rdo) | 2016-10-19 | 33 | 0 |
| K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | 2016-01-08 | 42 | 0 |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | Carolina Liquid Chemistries Corp. | 2014-05-08 | 252 | 0 |
| K120609 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 | 191 | 1 |
| K111516 | NMR LIPOPROFILE (R) TEST AND NMR PROFILER | Liposcience, Inc. | 2011-09-27 | 118 | 0 |
| K103747 | ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBR | Elitechgroup Seppim S.A.S. | 2011-08-31 | 251 | 0 |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; | Medica Corporation | 2011-07-12 | 89 | 0 |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL | Polymedco, Inc. | 2010-09-28 | 214 | 0 |
| K100010 | HDL CHOLESTEROL (HDLX) ASSAY | Beckman Coulter, Inc. | 2010-05-14 | 130 | 0 |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 9 | Wako Chemicals USA, Inc. | 2008-07-18 | 183 | 0 |
| K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 | Medica Corp. | 2008-04-14 | 123 | 0 |
| K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS | Diazyme Laboratories | 2008-01-03 | 129 | 0 |
| K072836 | CHOLESTRAK HDL CHOLESTEROL HOME TEST | Accutech, LLC | 2007-12-27 | 85 | 0 |
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIB | Clinical Data, Inc. | 2007-12-20 | 182 | 0 |
| K062092 | PREVU POINT OF CARE SKIN STEROL TEST | Premd, Inc. | 2006-09-15 | 53 | 0 |
| K053157 | AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48 | Dade Behring, Inc. | 2005-12-09 | 25 | 0 |
| K051962 | ULTRA HDL | Abbott Laboratories | 2005-08-25 | 37 | 0 |
| K050632 | ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY | Bayer Healthcare, LLC | 2005-05-26 | 78 | 0 |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | Diagnostic Chemicals , Ltd. | 2004-11-23 | 127 | 0 |
| K041090 | HDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2004-10-29 | 186 | 0 |
| K042006 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2004-10-28 | 94 | 2 |
| K042195 | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIP | Beckman Coulter, Inc. | 2004-09-16 | 34 | 0 |
| K040767 | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT | Beckman Coulter, Inc. | 2004-06-07 | 74 | 0 |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTE | Stanbio Laboratory | 2004-03-10 | 170 | 0 |
| K033610 | HDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | 2003-12-05 | 18 | 0 |
| K023640 | PICCOLO HDL TEST SYSTEM | Abaxis, Inc. | 2003-01-24 | 86 | 0 |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N- | Genzyme Corp. | 2002-07-25 | 91 | 0 |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | Jas Diagnostics, Inc. | 2002-07-19 | 59 | 0 |
| K014018 | CHOLESTEROL 1, 2, 3 | Imi | 2002-06-24 | 200 | 0 |
| K014032 | OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CAL | Olympus America, Inc. | 2002-02-08 | 64 | 0 |
| K014015 | OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CAL | Olympus America, Inc. | 2002-02-08 | 65 | 0 |
| K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR K | Elan Holdings, Inc. | 2001-11-09 | 50 | 0 |
| K012286 | MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENER | Roche Diagnostics Corp. | 2001-08-08 | 19 | 2 |
| K991664 | LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 | A.P. Total Care, Inc. | 1999-08-19 | 97 | 0 |
| K991665 | HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 | A.P. Total Care, Inc. | 1999-08-10 | 88 | 0 |
| K990581 | DIRECT HDL-CHOLESTEROL REAGENT | Kamiya Biomedical Co. | 1999-06-18 | 115 | 0 |
| K982539 | HDLC PRECIPITATING REAGENT | Ac Biochemicals, Inc. | 1998-09-15 | 56 | 0 |
| K981224 | DIRECT HDL | Abbott Laboratories | 1998-08-03 | 122 | 0 |
| K982341 | DIRECT HDL-CHOLESTROL LIQUID | Randox Laboratories, Ltd. | 1998-07-30 | 38 | 0 |
| K981899 | CARESIDE HDL-CHOLESTEROL | Exigent Diagnostics, Inc. | 1998-07-14 | 43 | 0 |
| K981580 | HDL | Abbott Laboratories | 1998-06-11 | 38 | 1 |
| K973988 | RDI HOMOGENEOUS HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1997-12-22 | 62 | 0 |
| K972041 | EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR | Sigma Diagnostics, Inc. | 1997-07-22 | 50 | 0 |
| K971162 | LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR | Genzyme Corp. | 1997-06-16 | 77 | 0 |
| K971190 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | Genzyme Corp. | 1997-06-16 | 77 | 0 |
| K971902 | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIREC | Roche Diagnostic Systems, Inc. | 1997-06-16 | 24 | 0 |
| K970735 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | Randox Laboratories, Ltd. | 1997-06-06 | 108 | 0 |
| K971526 | ACE HDL-C REAGENT | Schiapparelli Biosystems, Inc. | 1997-05-21 | 23 | 0 |
| K963213 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | Boehringer Mannheim Corp. | 1996-10-23 | 68 | 1 |
| K954778 | CHOLESTECH LDX SYSTEM | Cholestech Corp. | 1995-11-24 | 66 | 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