Cleared Traditional

K905457 - CLINICAL CHEMISTRY QUALITY CONTROL MATE...

K905457 is the FDA 510(k) clearance for CLINICAL CHEMISTRY QUALITY CONTROL MATE... by Consolidated Technologies, Inc.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K905457 · Consolidated Technologies, Inc. · Chemistry device
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Apr 1991
Decision
132d
Days
Class 1
Risk

K905457 is an FDA 510(k) clearance for the CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 132 days - within the typical 510(k) review window.

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

View all Consolidated Technologies, Inc. devices

Submission Details

510(k) Number K905457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date April 16, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 K905457.
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
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
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · Eastman Kodak Company · Aug 1990