Cleared Traditional

K032791 - GLYCOHEMOSURE HBA1C CONTROL (FDA 510(k) Clearance)

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

K032791 · Quantimetrix Corp. · Chemistry device
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Oct 2003
Decision
52d
Days
Class 2
Risk

K032791 is an FDA 510(k) clearance for the GLYCOHEMOSURE HBA1C CONTROL. Classified as Control, Hemoglobin (product code GGM), Class II - Special Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.8625 - 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 Quantimetrix Corp. devices

Submission Details

510(k) Number K032791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date October 30, 2003
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGM Control, Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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.