Cleared Traditional

K965169 - STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)

K965169 is an FDA 510(k) clearance for STABLELIN ENZYME LINEARITY TEST SET C (..., manufactured by Specialized Assays, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K965169 · Specialized Assays, Inc. · Chemistry device
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Feb 1997
Decision
44d
Days
Class 1
Risk

K965169 is an FDA 510(k) clearance for the STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003). 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 6, 1997 after a review of 44 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

FDA 510(k) Submission Details - K965169

510(k) Number K965169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date February 06, 1997
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

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 79
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