Cleared Traditional

K981536 - QUANTECH MYOGLOBIN ASSAY

K981536 is an FDA 510(k) clearance for QUANTECH MYOGLOBIN ASSAY, manufactured by Hellen Professional Services. The device is a Class 2 Immunology device with product code MVE cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K981536 · Hellen Professional Services · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Hellen Professional Services devices

FDA 510(k) Submission Details - K981536

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 105d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVE Device Classification - Class 2, Special Controls

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.