Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIX — Predicate Candidate Screening
120 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
168 days90th percentile
120clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251157 | Core Metabolic | Truvian Health | 2026-01-09 | 269 | 0 |
| K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | 2021-11-23 | 384 | 0 |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hell | Medicon Hellas S.A | 2021-09-21 | 536 | 0 |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-06-07 | 23 | 0 |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, | Biosystems S.A. | 2018-04-13 | 382 | 0 |
| K131488 | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM- | Alfa Wassermann Diagnostics Technologies, LLC | 2013-08-19 | 88 | 0 |
| K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-AR | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-13 | 240 | 0 |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATINI | Polymedco, Inc. | 2011-09-08 | 168 | 0 |
| K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL | Elitechgroup | 2011-06-21 | 88 | 1 |
| K101088 | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS | Medica Corp. | 2011-04-04 | 350 | 0 |
| K080874 | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214 | Medica Corp. | 2009-02-20 | 326 | 0 |
| K072143 | S40 CLINICAL ANALYZER, S TEST ALB | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-07-14 | 347 | 0 |
| K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENT | Horiba Abx | 2007-06-05 | 469 | 0 |
| K033009 | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 | Roche Diagnostics Corp. | 2003-10-16 | 20 | 2 |
| K030006 | ATAC PAK ALBUMIN REAGENT | Elan Diagnostics | 2003-03-07 | 64 | 0 |
| K023875 | VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUC | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 | 19 | 1 |
| K022072 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANAL | Precision Systems, Inc. | 2002-08-23 | 58 | 0 |
| K012329 | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 | Wiener Laboratories Saic | 2001-09-21 | 60 | 0 |
| K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2001-06-25 | 21 | 4 |
| K010877 | CHEMWELL, MODEL 2900 | Awareness Technology, Inc. | 2001-05-23 | 61 | 0 |
| K003327 | ALBUMIN | Jas Diagnostics, Inc. | 2000-12-05 | 42 | 0 |
| K992399 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-09-15 | 58 | 0 |
| K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Bayer Corp. | 1999-06-30 | 55 | 0 |
| K984494 | RANDOX ALBUMIN | Randox Laboratories, Ltd. | 1999-03-23 | 96 | 0 |
| K981758 | ALBG | Abbott Laboratories | 1998-06-12 | 24 | 1 |
| K981468 | ALBG | Abbott Laboratories | 1998-05-27 | 34 | 0 |
| K980041 | CARESIDE ALBUMIN | Exigent Diagnostics, Inc. | 1998-02-04 | 29 | 0 |
| K971445 | ALB OR ALBUMIN | Carolina Liquid Chemistries Corp. | 1997-05-02 | 11 | 0 |
| K955781 | ALBUMIN | Derma Media Lab., Inc. | 1996-03-13 | 83 | 0 |
| K952488 | TRACE COBAS MIRA RANGE | Trace Scientific , Ltd. | 1995-10-13 | 136 | 0 |
| K946355 | DMA ALBUMIN PROCEDURE | Data Medical Associates, Inc. | 1995-03-01 | 61 | 0 |
| K943000 | ALBUMIN QVET | Prisma Systems | 1994-12-13 | 173 | 0 |
| K935179 | EMDS ALBUMIN (ALB) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 | 52 | 0 |
| K924368 | OLYMPUS ALBUMIN REAGENT | Olympus Corp. | 1993-02-08 | 164 | 0 |
| K923959 | ALBUMIN TEST | Em Diagnostic Systems, Inc. | 1992-12-28 | 144 | 0 |
| K923322 | TRACE ALBUMIN-MR REAGENT | Trace Scientific , Ltd. | 1992-09-11 | 66 | 0 |
| K922369 | OLYMPUS ALBUMIN REAGENT | Olympus Corp. | 1992-07-17 | 58 | 0 |
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | Technicon Instruments Corp. | 1991-11-27 | 28 | 0 |
| K913920 | ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 | Em Diagnostic Systems, Inc. | 1991-09-27 | 24 | 0 |
| K913195 | KODAK EKTACHEM DT SLIDES (ALB) | Eastman Kodak Company | 1991-08-26 | 39 | 0 |
| K905660 | SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 | Em Diagnostic Systems, Inc. | 1991-01-25 | 38 | 0 |
| K903543 | SYNERMED ALBUMIN REAGENT KIT | Synermed, Inc. | 1990-10-12 | 66 | 0 |
| K901268 | COULTER ALBUMIN REAGENT | Coulter Corp. | 1990-05-30 | 75 | 0 |
| K896235 | COBAS READY ALBUMIN REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-27 | 120 | 0 |
| K896910 | CLINISTAT ALBUMIN REAGENT TEST | Miles Diagnostics Div. | 1990-01-18 | 38 | 0 |
| K893777 | ALBUMIN TEST (ALB) ITEM NUMBER: 65401 | Em Diagnostic Systems, Inc. | 1989-08-21 | 91 | 0 |
| K891375 | IQ ALBUMIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-05 | 57 | 0 |
| K885094 | BIOTROL ALBUMIN | Biotrol, USA, Inc. | 1989-02-10 | 63 | 0 |
| K884705 | ALBUMIN TEST (ALB) ITEM #65650 | Em Diagnostic Systems, Inc. | 1989-01-11 | 63 | 0 |
| K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM | A-Kem, Inc. | 1988-08-08 | 46 | 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