Cleared Traditional

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) (K965166) - FDA 510(k) Clearance

Class I Chemistry device.

K965166 · Specialized Assays, Inc. · Chemistry device
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Feb 1997
Decision
42d
Days
Class 1
Risk

K965166 is an FDA 510(k) clearance for the STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001). Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Specialized Assays, Inc. (Pipersville, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 42 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 Specialized Assays, Inc. devices

Submission Details

510(k) Number K965166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date February 04, 1997
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
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 - JJT Enzyme Controls (assayed And Unassayed)

All 96
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