Cleared Traditional

K963346 - STABILYPH UNASSAYED LIGAND ASSASY CONTROL

K963346 is the FDA 510(k) clearance for STABILYPH UNASSAYED LIGAND ASSASY CONTROL by Consolidated Technologies, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K963346 · Consolidated Technologies, Inc. · Chemistry device
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Sep 1996
Decision
14d
Days
Class 1
Risk

K963346 is an FDA 510(k) clearance for the STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on September 9, 1996 after a review of 14 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 Consolidated Technologies, Inc. devices

Submission Details

510(k) Number K963346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date September 09, 1996
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 464
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K963346.
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K964065 · Behring Diagnostics, Inc. · Nov 1996
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K961941 · Bio-Rad · Sep 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · Nova Biomedical Corp. · Aug 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997 · Nova Biomedical Corp. · Aug 1996
DOCUMENT CARDIAC ASSAYED CONTROL
K961750 · Casco Standards · Jul 1996