Cleared Traditional

K862420 - UTAK-STABBS TOXICOLOGY CONTROL

K862420 is the FDA 510(k) clearance for UTAK-STABBS TOXICOLOGY CONTROL by Utak Laboratories, Inc.. It is a Class 1 Toxicology device (product code JJY) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K862420 · Utak Laboratories, Inc. · Toxicology device
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Aug 1986
Decision
40d
Days
Class 1
Risk

K862420 is an FDA 510(k) clearance for the UTAK-STABBS TOXICOLOGY CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Utak Laboratories, Inc. (Canyon Country, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology 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 Utak Laboratories, Inc. devices

Submission Details

510(k) Number K862420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1986
Decision Date August 04, 1986
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
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 469
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K862420.
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
K861420 · Quantimetrix Corp. · Sep 1986
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K862963 · American Monitor Corp. · Sep 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · Ciba Corning Diagnostics Corp. · Jul 1986
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
K860906 · American Dade · May 1986
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID
K860942 · Quantimetrix Corp. · May 1986