Cleared Traditional

K831585 - ALBUMIN REAGENT (BCG

K831585 is the FDA 510(k) clearance for ALBUMIN REAGENT (BCG by Reagents Applications, Inc.. It is a Class 2 Immunology device (product code CIX) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K831585 · Reagents Applications, Inc. · Immunology device
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Jun 1983
Decision
30d
Days
Class 2
Risk

K831585 is an FDA 510(k) clearance for the ALBUMIN REAGENT (BCG. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1035 - the FDA immunology 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K831585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1983
Decision Date June 16, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 104d · This submission: 30d
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 Immunology 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 K831585.
ALBUMIN REAGENT SET
K841063 · Medical Specialties, Inc. · May 1984
ALBUMIN REAGENT
K840782 · American Dade · Apr 1984
ALBUMIN REAGENT CS-716
K833699 · Fisher Scientific Co., LLC · Jan 1984
FLOW-PAC ALBUMIN REAGENT
K830536 · Amresco, Inc. · Mar 1983
COBAS REAGENT FOR ALBUMIN
K823574 · Hoffmann-La Roche, Inc. · Jan 1983
COBAS STANDARDS FOR ALBUMIN
K823575 · Hoffmann-La Roche, Inc. · Jan 1983