Cleared Traditional

K903061 - UTAK LABORATORIES TOXICOLOGY CONTROL

K903061 is an FDA 510(k) clearance for UTAK LABORATORIES TOXICOLOGY CONTROL, manufactured by Utak Laboratories, Inc.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K903061 · Utak Laboratories, Inc. · Toxicology device
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Apr 1991
Decision
277d
Days
Class 1
Risk

K903061 is an FDA 510(k) clearance for the UTAK LABORATORIES TOXICOLOGY CONTROL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Utak Laboratories, Inc. (Canyon Country, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 277 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Utak Laboratories, Inc. devices

FDA 510(k) Submission Details - K903061

510(k) Number K903061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1990
Decision Date April 12, 1991
Days to Decision 277 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
190d slower than avg
Panel avg: 87d · This submission: 277d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - LAS Drug Specific Control Materials

All 69
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K903061.
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
K913677 · Analytical Control Systems, Inc. · Sep 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · Roche Diagnostic Systems, Inc. · Aug 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · Roche Diagnostic Systems, Inc. · Aug 1991
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829 · Bio-Rad · Apr 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · Roche Diagnostic Systems, Inc. · Mar 1991
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · Roche Diagnostic Systems, Inc. · Aug 1989