Cleared Traditional

NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER (K863438) - FDA 510(k) Clearance

Class I Chemistry device.

K863438 · Nova Biomedical Corp. · Chemistry device
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Sep 1986
Decision
24d
Days
Class 1
Risk

K863438 is an FDA 510(k) clearance for the NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER. Classified as Electrode, Ion Selective (non-specified) (product code JJP), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K863438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1986
Decision Date September 29, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJP Electrode, Ion Selective (non-specified)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.