Cleared Traditional

CHEMVARION(TM) (K862586) - FDA 510(k) Clearance

Class I Chemistry device.

K862586 · G.B.F. Industries, Inc. · Chemistry device
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Aug 1986
Decision
28d
Days
Class 1
Risk

K862586 is an FDA 510(k) clearance for the CHEMVARION(TM). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by G.B.F. Industries, Inc. (New York, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 G.B.F. Industries, Inc. devices

Submission Details

510(k) Number K862586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1986
Decision Date August 04, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 168
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K862586.
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227 · Bio-Rad · Jul 1987
MULTI-ANALYTE LIN-TROL
K863751 · Sigma Diagnostics, Inc. · Nov 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
PRECINORM IM AND PRECIPATH IM
K860970 · Boehringer Mannheim Corp. · Apr 1986
PRECINORM H & PRECIPATH H
K850017 · Boehringer Mannheim Corp. · Mar 1985