Cleared Traditional

K884178 - DRUG CONTROL SET

K884178 is the FDA 510(k) clearance for DRUG CONTROL SET by Gelman Sciences, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K884178 · Gelman Sciences, Inc. · Toxicology device
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Feb 1989
Decision
136d
Days
Class 1
Risk

K884178 is an FDA 510(k) clearance for the DRUG CONTROL SET. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gelman Sciences, Inc. devices

Submission Details

510(k) Number K884178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date February 17, 1989
Days to Decision 136 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
49d slower than avg
Panel avg: 87d · This submission: 136d
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 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K884178.
KIT- CIBA CORNING L-TDM I, II, III
K893682 · Ciba Corning Diagnostics Corp. · Sep 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · Ciba Corning Diagnostics Corp. · Jul 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957 · Hycor Biomedical, Inc. · Mar 1989
EMIT (R) HVA NEGATIVE URINE
K883210 · Syva Co. · Sep 1988
DADE TDM CONTROL
K883190 · Baxter Healthcare Corp · Sep 1988
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988