Cleared Traditional

K812950 - QAC CONTROL

K812950 is the FDA 510(k) clearance for QAC CONTROL by The Quality Assurance Service Corp.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K812950 · The Quality Assurance Service Corp. · Toxicology device
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Dec 1981
Decision
57d
Days
Class 1
Risk

K812950 is an FDA 510(k) clearance for the QAC CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by The Quality Assurance Service Corp. (Walker, US). The FDA issued a Cleared decision on December 17, 1981 after a review of 57 days - a notably fast clearance 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: 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 The Quality Assurance Service Corp. devices

Submission Details

510(k) Number K812950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1981
Decision Date December 17, 1981
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 149
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K812950.
EMIT-ST URINE CONTROLS SET A #3A349
K820462 · Syva Co. · Mar 1982
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BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · Stanbio Laboratory · Dec 1981
THERAPEUTIC DRUG CONTROL
K811756 · Icl Scientific · Jul 1981
EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL
K811618 · Syva Co. · Jun 1981
THERACHEM ANTI CONVULSANTA THEOPHYLLINE
K810504 · Fisher Scientific Co., LLC · Mar 1981