Cleared Traditional

Albumin BCP2 (K203530) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203530 · Abbott Ireland Diagnostics Division · Chemistry device
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Mar 2022
Decision
471d
Days
Class 2
Risk

K203530 is an FDA 510(k) clearance for the Albumin BCP2. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on March 18, 2022 after a review of 471 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abbott Ireland Diagnostics Division devices

Submission Details

510(k) Number K203530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2020
Decision Date March 18, 2022
Days to Decision 471 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
383d slower than avg
Panel avg: 88d · This submission: 471d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJW Bromcresol Purple 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 - CJW Bromcresol Purple Dye-binding, Albumin

All 10
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K203530.
Albumin BCP
K193001 · SENTINEL CH. SpA · Dec 2019
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
ALBP
K981814 · Abbott Laboratories · Jul 1998
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · Em Diagnostic Systems, Inc. · Oct 1991
ALBUMIN (BCP)
K863226 · Sigma Diagnostics, Inc. · Sep 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · Em Diagnostic Systems, Inc. · Sep 1986