Cleared Traditional

K920926 - KEMTROL SERUM CONTROL-ABNORMAL

K920926 is the FDA 510(k) clearance for KEMTROL SERUM CONTROL-ABNORMAL by Helena Laboratories. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K920926 · Helena Laboratories · Chemistry device
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May 1992
Decision
69d
Days
Class 1
Risk

K920926 is an FDA 510(k) clearance for the KEMTROL SERUM CONTROL-ABNORMAL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 7, 1992 after a review of 69 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 Helena Laboratories devices

Submission Details

510(k) Number K920926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date May 07, 1992
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K920926.
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636 · Baxter Diagnostics, Inc. · Jul 1992
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
K920927 · Helena Laboratories · Jun 1992
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
K921286 · Bio-Rad · Jun 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K920940 · Eastman Kodak Company · Apr 1992
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL
K920826 · Eastman Kodak Company · Apr 1992
CHEM-CHEM MULTI-ANALYTE (MODIFIED)
K920350 · Streck Laboratories, Inc. · Mar 1992