Cleared Traditional

K812950 - QAC CONTROL

K812950 is an FDA 510(k) clearance for QAC CONTROL, manufactured by The Quality Assurance Service Corp.. The device is a Class 1 Toxicology device with 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.

FDA 510(k) Submission Details - K812950

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 201
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
CONTROL SET
K820191 · Syva Co. · Feb 1982
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · Stanbio Laboratory · Dec 1981
THERAPEUTIC DRUG CONTROL
K811756 · Icl Scientific · Jul 1981
ANTI-ARRHYTHMIC CONTROL LEVELS I & II
K811809 · Environmental Chemical Specialties · Jul 1981
TDM ANTI-CONVULSANT CONTROL LEVELS I-II
K811811 · Environmental Chemical Specialties · Jul 1981
K812950 · QAC CONTROL
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