Cleared Traditional

K022746 - STAT PROFILE CRITICAL CARE XPRESS ANALYZER

K022746 is the FDA 510(k) clearance for STAT PROFILE CRITICAL CARE XPRESS ANALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K022746 · Nova Biomedical Corp. · Chemistry device
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Nov 2002
Decision
95d
Days
Class 2
Risk

K022746 is an FDA 510(k) clearance for the STAT PROFILE CRITICAL CARE XPRESS ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K022746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2002
Decision Date November 22, 2002
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 107
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K022746.
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K021713 · Nova Biomedical Corp. · Jul 2002
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K021515 · Medica Corp. · Jul 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · Nova Biomedical Corp. · Jun 2002