Cleared Traditional

QUANTECH MYOGLOBIN ASSAY (K981536) - FDA 510(k) Clearance

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

K981536 · Hellen Professional Services · Immunology device
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Jun 1998
Decision
61d
Days
Class 2
Risk

K981536 is an FDA 510(k) clearance for the QUANTECH MYOGLOBIN ASSAY. Classified as Biosensor, Immunoassay, Myoglobin (product code MVE), Class II - Special Controls.

Submitted by Hellen Professional Services (Northridge, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5680 - the FDA immunology device 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.

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Submission Details

510(k) Number K981536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1998
Decision Date June 29, 1998
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 104d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVE Biosensor, Immunoassay, Myoglobin
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 Immunology devices follow this clearance model.