Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LPS — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
224 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 | 146 | 0 |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | Diazyme Laboratories | 2012-07-31 | 116 | 0 |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATO | Tosoh Bioscience, Inc. | 2012-06-15 | 22 | 0 |
| K113793 | HOMOCYSTEINE TEST | Roche | 2012-06-05 | 165 | 2 |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | Axis-Shield Diagnostics, Ltd. | 2012-05-07 | 224 | 0 |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, | Axis-Shield Diagnostics, Ltd. | 2009-07-31 | 270 | 1 |
| K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2008-10-10 | 198 | 0 |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | 2008-04-24 | 120 | 0 |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALI | Diazyme Laboratories | 2007-09-17 | 62 | 0 |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Teco Diagnostics | 2007-04-11 | 119 | 0 |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIB | Dade Behring, Inc. | 2006-12-28 | 66 | 2 |
| K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | Catch Incorporated | 2006-10-13 | 24 | 0 |
| K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | Instrumentation Laboratory CO | 2006-09-22 | 106 | 0 |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2006-07-21 | 43 | 1 |
| K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA A | Diazyme Laboratories | 2006-06-13 | 35 | 0 |
| K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/ | Dade Behring, Inc. | 2006-03-29 | 177 | 0 |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CH | Polymedco, Inc. | 2004-02-04 | 70 | 0 |
| K032012 | HOMOCYSTEINE MICROTITER PLATE ASSAY | Diazyme Laboratories | 2003-09-03 | 65 | 0 |
| K030754 | A/C ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2003-07-11 | 123 | 0 |
| K013606 | ACS 180 HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | 2001-12-21 | 51 | 0 |
| K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | 2001-12-18 | 64 | 2 |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Intersect Systems, Inc. | 2001-07-25 | 55 | 1 |
| K011689 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Catch, Inc. | 2001-07-25 | 55 | 1 |
| K003597 | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEI | Diagnostic Products Corp. | 2001-02-05 | 76 | 0 |
| K993107 | BIO-RAD HOMOCYSTEINE BY HPLC | Bio-Rad | 1999-12-21 | 95 | 0 |
| K992858 | ABBOTT AXSYM HOMOCYSTEINE | Abbott Laboratories | 1999-10-25 | 61 | 1 |
| K992274 | MODIFICATION TO IMX HOMOCYSTEINE | Axis Biochemicals, Asa | 1999-10-06 | 92 | 0 |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | Drew Scientific , Ltd. | 1999-02-11 | 248 | 0 |
| K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY | Axis Biochemicals, Asa | 1998-10-16 | 220 | 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