Cleared Traditional

K905264 - STAT PROFILE 8 ANALYZER

K905264 is the FDA 510(k) clearance for STAT PROFILE 8 ANALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K905264 · Nova Biomedical Corp. · Chemistry device
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Mar 1991
Decision
104d
Days
Class 2
Risk

K905264 is an FDA 510(k) clearance for the STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 K905264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1990
Decision Date March 05, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 99
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K905264.
NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
K912559 · Nova Biomedical Corp. · Jul 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · Instrumentation Laboratory CO · Jun 1991
CLINAK(TM) ISE SUBSYSTEM
K910554 · Baxter Healthcare Corp · Mar 1991
SECONDARY CALIBRATORS
K904335 · Bionostics, Inc. · Oct 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · Abbott Laboratories · Sep 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · Baxter Healthcare Corp · Jan 1990