Cleared Traditional

K862420 - UTAK-STABBS TOXICOLOGY CONTROL

K862420 is an FDA 510(k) clearance for UTAK-STABBS TOXICOLOGY CONTROL, manufactured by Utak Laboratories, Inc.. The device is a Class 1 Toxicology device with 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

FDA 510(k) Submission Details - K862420

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 598
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K862420.
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K860906 · American Dade · May 1986
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