Cleared Traditional

K963005 - NOVA 16 ANALYZER (MODIFICATION POINT OF...

K963005 is the FDA 510(k) clearance for NOVA 16 ANALYZER (MODIFICATION POINT OF... by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code JFL) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K963005 · Nova Biomedical Corp. · Chemistry device
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Aug 1996
Decision
21d
Days
Class 2
Risk

K963005 is an FDA 510(k) clearance for the NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE). Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on August 23, 1996 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 K963005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1996
Decision Date August 23, 1996
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - JFL Ph Rate Measurement, Carbon-dioxide

All 18
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K963005.
SIGMA DIAGNOSTICS CO2 ACID REAGENT
K963541 · Sigma Diagnostics, Inc. · Oct 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
K963538 · Sigma Diagnostics, Inc. · Oct 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
K963540 · Sigma Diagnostics, Inc. · Sep 1996
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · Sigma Chemical Co. · Jan 1994
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691 · Sigma Chemical Co. · Dec 1993
SIGMA CO2 ACID REAGENT
K933692 · Sigma Chemical Co. · Dec 1993