Cleared Traditional

K905457 - CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL

K905457 is an FDA 510(k) clearance for CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL, manufactured by Consolidated Technologies, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K905457

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 175
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
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ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
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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