Cleared Traditional

K203530 - Albumin BCP2 (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.