Cleared Traditional

K911167 - ACS THERAPEUTIC DRUG MONIT CONTR

K911167 is the FDA 510(k) clearance for ACS THERAPEUTIC DRUG MONIT CONTR by Analytical Control Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K911167 · Analytical Control Systems, Inc. · Toxicology device
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May 1991
Decision
47d
Days
Class 1
Risk

K911167 is an FDA 510(k) clearance for the ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on May 1, 1991 after a review of 47 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K911167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date May 01, 1991
Days to Decision 47 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
40d faster than avg
Panel avg: 87d · This submission: 47d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K911167.
TDM I LINEARITY TEST SET
K913309 · Casco Standards · Sep 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724 · E.I. Dupont DE Nemours & Co., Inc. · May 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930 · Analytical Control Systems, Inc. · May 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168 · Analytical Control Systems, Inc. · May 1991
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
K910333 · Medical Analysis Systems, Inc. · Apr 1991
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905 · Medical Analysis Systems, Inc. · Dec 1990