Cleared Traditional

CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (K972976) - FDA 510(k) Clearance

Class I Chemistry device.

K972976 · More Diagnostics · Chemistry device
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Aug 1997
Decision
18d
Days
Class 1
Risk

K972976 is an FDA 510(k) clearance for the CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all More Diagnostics devices

Submission Details

510(k) Number K972976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date August 29, 1997
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
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 96
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K972976.
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K961828 · Bio-Rad · Jun 1996