Cleared Traditional

QUANTIMETRIX TOTAL CREATINE KINASE CONTROL (K874302) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

Device Classification

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 29
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K874302.
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · Bio-Rad · Aug 1990
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · Baxter Healthcare Corp · Aug 1988
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · Helena Laboratories · Nov 1987
VIRON(TM)
K872646 · bioMerieux, Inc. · Sep 1987
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · Em Diagnostic Systems, Inc. · May 1986