Cleared Traditional

ALBUMIN REAGENT SET (K905776) - FDA 510(k) Clearance

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

K905776 · Biochemical Trade, Inc. · Toxicology device
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Feb 1991
Decision
61d
Days
Class 2
Risk

K905776 is an FDA 510(k) clearance for the ALBUMIN REAGENT SET. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 61 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biochemical Trade, Inc. devices

Submission Details

510(k) Number K905776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date February 26, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 87d · This submission: 61d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CJW Bromcresol Purple Dye-binding, Albumin

All 17
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K905776.
Albumin BCP2
K203530 · Abbott Ireland Diagnostics Division · Mar 2022
Albumin BCP
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ALBP
K981814 · Abbott Laboratories · Jul 1998
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · Em Diagnostic Systems, Inc. · Oct 1991
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · Em Diagnostic Systems, Inc. · Sep 1986
VISION ALBUMIN
K862138 · Abbott Laboratories · Jun 1986