Cleared Traditional

K860340 - SERUM ALBUMIN (BCG) REAGENT SET

K860340 is the FDA 510(k) clearance for SERUM ALBUMIN (BCG) REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K860340 · Sterling Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
21d
Days
Class 2
Risk

K860340 is an FDA 510(k) clearance for the SERUM ALBUMIN (BCG) REAGENT SET. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 19, 1986 after a review of 21 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K860340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date February 19, 1986
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 77
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K860340.
ALBUMIN PROCEDURE
K861654 · Data Medical Associates, Inc. · Jun 1986
ALBUMIN (BCG) REAGENT
K861467 · Sigma Diagnostics, Inc. · May 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · Amresco, Inc. · Mar 1986
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · Clinical Data, Inc. · Nov 1985
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · Medical Analysis Systems, Inc. · Sep 1985