Cleared Traditional

K880750 - NOVA STAT PROFILE 6 ANALYZER + QUALITY ...

K880750 is the FDA 510(k) clearance for NOVA STAT PROFILE 6 ANALYZER + QUALITY ... by Nova Biomedical Corp.. It is a Class 2 Chemistry device (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.

View all Nova Biomedical Corp. devices

Submission Details

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.

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 K880750.
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · Technicon Instruments Corp. · Oct 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218 · Nova Biomedical Corp. · Sep 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500 · Ciba Corning Diagnostics Corp. · Jul 1989
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255 · Nova Biomedical Corp. · May 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
K874832 · Nova Biomedical Corp. · Feb 1988
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263 · Technicon Instruments Corp. · Feb 1988