Cleared Traditional

K991727 - STAT PROFILE M7 ANALYZER

K991727 is an FDA 510(k) clearance for STAT PROFILE M7 ANALYZER, manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code CGL cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K991727 · Nova Biomedical Corp. · Chemistry device
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Jul 1999
Decision
57d
Days
Class 2
Risk

K991727 is an FDA 510(k) clearance for the STAT PROFILE M7 ANALYZER. Classified as Electrode, Ion Based, Enzymatic, Creatinine (product code CGL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on July 16, 1999 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Nova Biomedical Corp. devices

FDA 510(k) Submission Details - K991727

510(k) Number K991727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1999
Decision Date July 16, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGL Device Classification - Class 2, Special Controls

Product Code CGL Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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.

Regulatory Peers - CGL Electrode, Ion Based, Enzymatic, Creatinine

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