Cleared Traditional

K982679 - MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982679 · Spectral Diagnostics, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
68d
Days
Class 2
Risk

K982679 is an FDA 510(k) clearance for the MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on October 7, 1998 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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 K982679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date October 07, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.