Cleared Traditional

K862419 - SERUM VANCOMYCIN TOXICOLOGY CONTROL

K862419 is an FDA 510(k) clearance for SERUM VANCOMYCIN 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 141-day FDA review.

K862419 · Utak Laboratories, Inc. · Toxicology device
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Nov 1986
Decision
141d
Days
Class 1
Risk

K862419 is an FDA 510(k) clearance for the SERUM VANCOMYCIN 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 November 13, 1986 after a review of 141 days - within the typical 510(k) review window.

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 - K862419

510(k) Number K862419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1986
Decision Date November 13, 1986
Days to Decision 141 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
54d slower than avg
Panel avg: 87d · This submission: 141d
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 K862419.
DIGOXIN FPIA CONTROLS
K872347 · Sigma Diagnostics, Inc. · Jul 1987
PHENYTOIN FPIA CONTROLS
K871567 · Sigma Diagnostics, Inc. · Jul 1987
BENZODIAZEPINES TOXICOLOGY CONTROL
K862418 · Utak Laboratories, Inc. · Nov 1986
SERUM CLONAZEPAM TOXICOLOGY CONTROL
K862421 · Utak Laboratories, Inc. · Nov 1986
EMIT 700 CANNABINOID CONTROL SET
K843419 · Syva Co. · Oct 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · E.I. Dupont DE Nemours & Co., Inc. · May 1984