CIX · Bromcresol Green Dye-Binding, Albumin
Clinical Chemistry · 21 CFR 862.1035 · Class 2
Overview
| Product Code | CIX |
|---|---|
| Device Name | Bromcresol Green Dye-Binding, Albumin |
| Regulation | 21 CFR 862.1035 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 120)
Showing 20 most recent of 120 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251157 | Core Metabolic | Truvian Health | Jan 9, 2026 | SESE |
| K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | Nov 23, 2021 | SESE |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin | Medicon Hellas S.A | Sep 21, 2021 | SESE |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | Jun 7, 2019 | SESE |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | Biosystems S.A. | Apr 13, 2018 | SESE |
| K131488 | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT | Alfa Wassermann Diagnostics Technologies, LLC | Aug 19, 2013 | SESE |
| K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Jul 13, 2012 | SESE |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | Polymedco, Inc. | Sep 8, 2011 | SESE |
| K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH | Elitechgroup | Jun 21, 2011 | SESE |
| K101088 | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT | Medica Corp. | Apr 4, 2011 | SESE |
| K080874 | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT | Medica Corp. | Feb 20, 2009 | SESE |
| K072143 | S40 CLINICAL ANALYZER, S TEST ALB | Alfa Wassermann Diagnostic Technologies, Inc. | Jul 14, 2008 | SESE |
| K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL | Horiba Abx | Jun 5, 2007 | SESE |
| K033009 | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 | Roche Diagnostics Corp. | Oct 16, 2003 | SESE |
| K030006 | ATAC PAK ALBUMIN REAGENT | Elan Diagnostics | Mar 7, 2003 | SESE |
| K023875 | VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 | Ortho-Clinical Diagnostics, Inc. | Dec 10, 2002 | SESE |
| K022072 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS | Precision Systems, Inc. | Aug 23, 2002 | SESE |
| K012329 | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 | Wiener Laboratories Saic | Sep 21, 2001 | SESE |
| K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | Jun 25, 2001 | SESE |
| K010877 | CHEMWELL, MODEL 2900 | Awareness Technology, Inc. | May 23, 2001 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 9 clearances
- Harleco — 5 clearances
- Abbott Laboratories — 4 clearances
- Data Medical Associates, Inc. — 3 clearances
- Technicon Instruments Corp. — 3 clearances
