Cleared Traditional

K931105 - PROCHECK(TM) BLIND PERFORMANCE SPECIMENS

K931105 is an FDA 510(k) clearance for PROCHECK(TM) BLIND PERFORMANCE SPECIMENS, manufactured by Dynagen, Inc.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K931105 · Dynagen, Inc. · Toxicology device
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Apr 1993
Decision
49d
Days
Class 1
Risk

K931105 is an FDA 510(k) clearance for the PROCHECK(TM) BLIND PERFORMANCE SPECIMENS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Dynagen, Inc. (Cambridge, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 49 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 Dynagen, Inc. devices

FDA 510(k) Submission Details - K931105

510(k) Number K931105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date April 21, 1993
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 87d · This submission: 49d
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 176
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K931105.
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · Roche Diagnostic Systems, Inc. · Aug 1993
ABUSCREEN ONLINE CONTROL
K931125 · Roche Diagnostic Systems, Inc. · Aug 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · Bio-Rad · Jul 1993
COBAS-FP TDM CONTROLS
K930269 · Roche Diagnostic Systems, Inc. · Feb 1993
DRUG OF ABUSE URINE CONTROL
K920477 · Diagnostic Reagents, Inc. · Mar 1992
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · Bio-Rad · Nov 1991