Cleared Traditional

K874302 - QUANTIMETRIX TOTAL CREATINE KINASE CONTROL

K874302 is an FDA 510(k) clearance for QUANTIMETRIX TOTAL CREATINE KINASE CONTROL, manufactured by Quantimetrix Medical Industries. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K874302 · Quantimetrix Medical Industries · Chemistry device
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Feb 1988
Decision
105d
Days
Class 1
Risk

K874302 is an FDA 510(k) clearance for the QUANTIMETRIX TOTAL CREATINE KINASE CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Quantimetrix Medical Industries (Hawthorne, US). The FDA issued a Cleared decision on February 2, 1988 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Quantimetrix Medical Industries devices

FDA 510(k) Submission Details - K874302

510(k) Number K874302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date February 02, 1988
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 82
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K874302.
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · Baxter Healthcare Corp · Aug 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · Quantimetrix Corp. · Mar 1988
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · Helena Laboratories · Nov 1987
VIRON(TM)
K872646 · bioMerieux, Inc. · Sep 1987
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737 · U. S. Diagnostics, Inc. · Apr 1987