Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1035](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1035) → CIX — Bromcresol Green Dye-Binding, Albumin # CIX · Bromcresol Green Dye-Binding, Albumin _Clinical Chemistry · 21 CFR 862.1035 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX ## Overview - **Product Code:** CIX - **Device Name:** Bromcresol Green Dye-Binding, Albumin - **Regulation:** [21 CFR 862.1035](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1035) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K251157.md) | Core Metabolic | Truvian Health | Jan 9, 2026 | SESE | | [K203248](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K203248.md) | Albumin BCG2 | Abbott Ireland Diagnostics Division | Nov 23, 2021 | SESE | | [K200898](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K200898.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K191316.md) | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | Jun 7, 2019 | SESE | | [K170901](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K170901.md) | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | Biosystems S.A. | Apr 13, 2018 | SESE | | [K131488](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K131488.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K113374.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K110818.md) | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | Polymedco, Inc. | Sep 8, 2011 | SESE | | [K110830](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K110830.md) | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH | Elitechgroup | Jun 21, 2011 | SESE | | [K101088](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K101088.md) | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT | Medica Corp. | Apr 4, 2011 | SESE | | [K080874](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K080874.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K072143.md) | S40 CLINICAL ANALYZER, S TEST ALB | Alfa Wassermann Diagnostic Technologies, Inc. | Jul 14, 2008 | SESE | | [K060434](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K060434.md) | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL | Horiba Abx | Jun 5, 2007 | SESE | | [K033009](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K033009.md) | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 | Roche Diagnostics Corp. | Oct 16, 2003 | SESE | | [K030006](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K030006.md) | ATAC PAK ALBUMIN REAGENT | Elan Diagnostics | Mar 7, 2003 | SESE | | [K023875](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K023875.md) | VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 | Ortho-Clinical Diagnostics, Inc. | Dec 10, 2002 | SESE | | [K022072](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K022072.md) | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS | Precision Systems, Inc. | Aug 23, 2002 | SESE | | [K012329](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K012329.md) | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 | Wiener Laboratories Saic | Sep 21, 2001 | SESE | | [K011720](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K011720.md) | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | Jun 25, 2001 | SESE | | [K010877](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K010877.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com