Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JJT — Predicate Candidate Screening
97 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
88 days90th percentile
97clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | Astoria-Pacific, Inc. | 2009-12-14 | 255 | 0 |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | Quantimetrix Corp. | 2006-10-03 | 19 | 0 |
| K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TR | Cliniqa Corporation | 2003-03-21 | 10 | 1 |
| K030102 | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | Bayer Healthcare, LLC | 2003-01-24 | 14 | 0 |
| K021498 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRIL | Bio-Rad | 2002-05-24 | 15 | 0 |
| K012656 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646 | Bio-Rad | 2001-09-06 | 24 | 0 |
| K993723 | CARDIASURE CARDIAC MARKERS CONTROL | Quantimetrix Corp. | 1999-11-23 | 20 | 0 |
| K993715 | QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 | Seracare Technology | 1999-11-16 | 13 | 0 |
| K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1999-08-30 | 40 | 0 |
| K984437 | QUANTEX ASO-CRP-RP CONTROL II | Instrumentation Laboratory CO | 1999-02-02 | 50 | 0 |
| K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1998-12-09 | 9 | 0 |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS N | More Diagnostics | 1998-08-21 | 9 | 0 |
| K980556 | LIQUICHEK CARDIAC MARKERS CONTROL LT | Bio-Rad | 1998-02-25 | 12 | 0 |
| K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE C | Biosite Incorporated | 1997-12-10 | 15 | 0 |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Intl., Inc. | 1997-11-06 | 17 | 0 |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEV | More Diagnostics | 1997-08-29 | 18 | 0 |
| K972408 | CARDIAC STATUS CONTROLS | Spectral Diagnostics, Inc. | 1997-07-25 | 29 | 0 |
| K971777 | QUANTEX ASO-CRP-RF CONTROL | Instrumentation Laboratory CO | 1997-05-27 | 13 | 0 |
| K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL | Medical Analysis Systems, Inc. | 1997-04-08 | 29 | 0 |
| K965169 | STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) | Specialized Assays, Inc. | 1997-02-06 | 44 | 0 |
| K965166 | STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) | Specialized Assays, Inc. | 1997-02-04 | 42 | 0 |
| K965168 | STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) | Specialized Assays, Inc. | 1997-02-04 | 42 | 0 |
| K961828 | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) | Bio-Rad | 1996-06-11 | 29 | 0 |
| K960275 | OPUS CK-MB & TOTAL CK CONTROLS | Behring Diagnostics, Inc. | 1996-04-25 | 97 | 0 |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | Ciba Corning Diagnostics Corp. | 1996-04-23 | 98 | 0 |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 8 | Isolab, Inc. | 1995-09-21 | 212 | 2 |
| K951293 | QUANTITATE ENZYME VERIFIER SET | Beckman Instruments, Inc. | 1995-04-20 | 29 | 0 |
| K950801 | CARDIO REP LD CONTROL - CAT NO. 3325 | Helena Laboratories | 1995-03-30 | 37 | 0 |
| K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION | Clinical Controls, Inc. | 1995-01-24 | 39 | 0 |
| K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL | Clinical Controls, Inc. | 1995-01-24 | 39 | 0 |
| K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, | Clinical Controls, Inc. | 1994-11-04 | 29 | 0 |
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | Cala Diagnostics | 1994-10-31 | 61 | 0 |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | Cala Diagnostics | 1994-10-31 | 61 | 0 |
| K944243 | CARDIOCHEX | Cala Diagnostics | 1994-10-27 | 57 | 0 |
| K943684 | HICHEM ENZYME VERIFIER KIT | Hi Chem, Inc. | 1994-10-04 | 67 | 0 |
| K932442 | CARDIO REP RECOMBINANT CK ABNORMAL CONTROL | Helena Laboratories | 1993-10-28 | 161 | 0 |
| K930889 | ROCHE CARDIOTROL-CK | Roche Diagnostic Systems, Inc. | 1993-07-06 | 134 | 0 |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | Cala Diagnostics | 1993-04-13 | 53 | 0 |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | Cala Diagnostics | 1993-04-13 | 53 | 0 |
| K925151 | LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 | Bio-Rad | 1992-12-17 | 65 | 0 |
| K905623 | CK-MB IMMUNOASSAY CONTROL | Seradyn, Inc. | 1991-02-22 | 70 | 0 |
| K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 | Bio-Rad | 1990-08-23 | 23 | 0 |
| K902321 | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) | Hichem Diagnostics | 1990-06-28 | 36 | 0 |
| K896465 | CLP CK/LD ISOENZYME/IMMUNO CONTROL | Creative Laboratory Products, Inc. | 1990-03-01 | 108 | 0 |
| K894554 | CLP CK/LD ISOENZYME CONTROL | Creative Laboratory Products, Inc. | 1989-10-16 | 88 | 0 |
| K894207 | CK-MB/LD-1 CONTROL SYSTEM | Boehringer Mannheim Corp. | 1989-08-28 | 70 | 0 |
| K883395 | ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY | Quantimetrix Medical Industries | 1988-09-19 | 39 | 0 |
| K882795 | DADE(R) CK-MB IMMUNOASSAY CONTROL | Baxter Healthcare Corp | 1988-08-29 | 54 | 0 |
| K880701 | QUANTIMETRIX SERUM ENZYME CONTROL | Quantimetrix Corp. | 1988-03-24 | 31 | 0 |
| K880266 | MULTI-ENZYME LINEARITY SOLUTION | Verichem Laboratories, Inc. | 1988-02-18 | 27 | 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