Cleared Traditional

K955264 - NOVA CHEMISTRY CONTROLS

K955264 is the FDA 510(k) clearance for NOVA CHEMISTRY CONTROLS by Nova Biomedical Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K955264 · Nova Biomedical Corp. · Chemistry device
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Feb 1996
Decision
79d
Days
Class 1
Risk

K955264 is an FDA 510(k) clearance for the NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2. 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 February 2, 1996 after a review of 79 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 K955264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1995
Decision Date February 02, 1996
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K955264.
N/T PROTEIN CONTROL SY/L, M AND H
K955858 · Behring Diagnostics, Inc. · Feb 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
K955252 · Nova Biomedical Corp. · Feb 1996
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
K955260 · Nova Biomedical Corp. · Feb 1996
ROCHE CONTROL SERUM N
K954655 · Roche Diagnostic Systems, Inc. · Dec 1995
ROCHE CONTROL SERUM P
K954656 · Roche Diagnostic Systems, Inc. · Dec 1995
LIQUICHEK ETHANOL/AMMONIA CONTROL
K955024 · Bio-Rad · Nov 1995