Cleared Traditional

K861467 - ALBUMIN (BCG) REAGENT

K861467 is the FDA 510(k) clearance for ALBUMIN (BCG) REAGENT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K861467 · Sigma Diagnostics, Inc. · Chemistry device
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May 1986
Decision
32d
Days
Class 2
Risk

K861467 is an FDA 510(k) clearance for the ALBUMIN (BCG) REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 32 days - a notably fast clearance cycle.

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: 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K861467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1986
Decision Date May 23, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K861467.
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
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ALBUMIN PROCEDURE
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ALBUMIN PROCEDURE
K861654 · Data Medical Associates, Inc. · Jun 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · Amresco, Inc. · Mar 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340 · Sterling Diagnostics, Inc. · Feb 1986
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · Clinical Data, Inc. · Nov 1985