Cleared Traditional

K880750 - NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT

K880750 is an FDA 510(k) clearance for NOVA STAT PROFILE 6 ANALYZER + QUALITY ..., 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 128-day FDA review.

K880750 · Nova Biomedical Corp. · Chemistry device
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Jul 1988
Decision
128d
Days
Class 2
Risk

K880750 is an FDA 510(k) clearance for the NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT. 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 July 1, 1988 after a review of 128 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.

FDA 510(k) Submission Details - K880750

510(k) Number K880750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date July 01, 1988
Days to Decision 128 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
40d slower than avg
Panel avg: 88d · This submission: 128d
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 155
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K880750.
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K880750 · NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
Download PDF Nova Biomedical Corp.