Cleared Traditional

K962997 - NOVA CHEMISTRY CONTROLS WITH CREATININE

K962997 is the FDA 510(k) clearance for NOVA CHEMISTRY CONTROLS WITH CREATININE by Nova Biomedical Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K962997 · Nova Biomedical Corp. · Chemistry device
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Aug 1996
Decision
13d
Days
Class 1
Risk

K962997 is an FDA 510(k) clearance for the NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K962997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1996
Decision Date August 15, 1996
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 369
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K962997.
N/T PROTEIN CONTROL SL
K964065 · Behring Diagnostics, Inc. · Nov 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941 · Bio-Rad · Sep 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · Nova Biomedical Corp. · Aug 1996
ELECSYS PRECICONTROL CARDIAC
K962575 · Boehringer Mannheim Corp. · Jul 1996
CHEM-CHEX STAT
K961195 · Streck Laboratories, Inc. · May 1996
IMMUNOLOGY CONTROL
K960824 · Medical Analysis Systems, Inc. · Apr 1996