Cleared Traditional

K913309 - TDM I LINEARITY TEST SET

K913309 is the FDA 510(k) clearance for TDM I LINEARITY TEST SET by Casco Standards. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K913309 · Casco Standards · Chemistry device
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Sep 1991
Decision
50d
Days
Class 1
Risk

K913309 is an FDA 510(k) clearance for the TDM I LINEARITY TEST SET. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - the FDA in vitro diagnostics and chemistry 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.

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Submission Details

510(k) Number K913309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date September 13, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K913309.
DRUG OF ABUSE URINE CONTROL
K920477 · Diagnostic Reagents, Inc. · Mar 1992
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · Bio-Rad · Nov 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · Roche Diagnostic Systems, Inc. · Nov 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 II
K911167 · Analytical Control Systems, Inc. · May 1991