Cleared Traditional

K951135 - MULTI-DRUG CONTROL SET

K951135 is the FDA 510(k) clearance for MULTI-DRUG CONTROL SET by Microgenics Corp.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K951135 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
31d
Days
Class 1
Risk

K951135 is an FDA 510(k) clearance for the MULTI-DRUG CONTROL SET. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 31 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.

View all Microgenics Corp. devices

Submission Details

510(k) Number K951135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date April 13, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K951135.
ABUSCREEN ONLINE CONTROLS
K953739 · Roche Diagnostic Systems, Inc. · Sep 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · Roche Diagnostic Systems, Inc. · Sep 1995
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056 · Medi-Tech, Inc. · Jun 1995
DRUGS OF ABUSE CONTROLS
K950138 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · Roche Diagnostic Systems, Inc. · Jan 1995
ABUSCREEN ONLINE CONTROLS
K945194 · Roche Diagnostic Systems, Inc. · Dec 1994