Cleared Traditional

CHEMTROL(TM) (K862565) - FDA 510(k) Clearance

Class I Chemistry device.

K862565 · G.B.F. Industries, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
190d
Days
Class 1
Risk

K862565 is an FDA 510(k) clearance for the CHEMTROL(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 January 13, 1987 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all G.B.F. Industries, Inc. devices

Submission Details

510(k) Number K862565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1986
Decision Date January 13, 1987
Days to Decision 190 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 88d · This submission: 190d
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 167
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K862565.
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · Bio-Rad · Jan 1988
PRECINORM L
K874230 · Boehringer Mannheim Corp. · Nov 1987
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