Cleared Traditional

K203248 - Albumin BCG2

K203248 is an FDA 510(k) clearance for Albumin BCG2, manufactured by Abbott Ireland Diagnostics Division. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K203248 · Abbott Ireland Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
384d
Days
Class 2
Risk

K203248 is an FDA 510(k) clearance for the Albumin BCG2. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on November 23, 2021 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Ireland Diagnostics Division devices

FDA 510(k) Submission Details - K203248

510(k) Number K203248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2020
Decision Date November 23, 2021
Days to Decision 384 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 88d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 82
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K203248.
Core Metabolic
K251157 · Truvian Health · Jan 2026
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
K200898 · Medicon Hellas S.A · Sep 2021
VITROS XT Chemistry Products ALB-TP Slides
K191316 · Ortho-Clinical Diagnostics, Inc. · Jun 2019
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
K170901 · Biosystems S.A. · Apr 2018
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
K101088 · Medica Corp. · Apr 2011
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
K080874 · Medica Corp. · Feb 2009