Cleared Traditional

ALB BCG REAGENT (K852007) - FDA 510(k) Clearance

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

K852007 · Alpkem Corp. · Chemistry device
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May 1985
Decision
23d
Days
Class 2
Risk

K852007 is an FDA 510(k) clearance for the ALB BCG REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 30, 1985 after a review of 23 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 Alpkem Corp. devices

Submission Details

510(k) Number K852007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date May 30, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
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 25
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K852007.
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · Em Diagnostic Systems, Inc. · Oct 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · Em Diagnostic Systems, Inc. · Dec 1986
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
SYSTEMATE ALBUMIN
K843108 · Em Diagnostic Systems, Inc. · Aug 1984
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030 · Eastman Kodak Company · Aug 1981
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · Beckman Instruments, Inc. · Sep 1980