Cleared Traditional

K981474 - CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (FDA 510(k) Clearance)

Class I Chemistry device.

K981474 · Spectral Diagnostics, Inc. · Chemistry device
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May 1998
Decision
13d
Days
Class 1
Risk

K981474 is an FDA 510(k) clearance for the CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on May 7, 1998 after a review of 13 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 Spectral Diagnostics, Inc. devices

Submission Details

510(k) Number K981474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1998
Decision Date May 07, 1998
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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.