Cleared Traditional

K905264 - STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS

K905264 is an FDA 510(k) clearance for STAT PROFILE 8 ANALYZER, manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K905264

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.

JGS Device Classification - Class 2, Special Controls

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 133
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
IONOMETER EF-HK AND ACCESSORIES
K901042 · Fresenius USA, Inc. · Jul 1990