Cleared Traditional

K992502 - AXIS %CDT TURBIDIMETRIC IMMUNOASSAY

K992502 is an FDA 510(k) clearance for AXIS %CDT TURBIDIMETRIC IMMUNOASSAY, manufactured by Axis. The device is a Class 1 Chemistry device with product code NAO cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K992502 · Axis · Chemistry device
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Dec 1999
Decision
148d
Days
Class 1
Risk

K992502 is an FDA 510(k) clearance for the AXIS %CDT TURBIDIMETRIC IMMUNOASSAY. Classified as Test, Carbohydrate Deficient Transferrin (product code NAO), Class I - General Controls.

Submitted by Axis (San Diego, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K992502

510(k) Number K992502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date December 21, 1999
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

NAO Device Classification - Class 1, General Controls

Product Code NAO Test, Carbohydrate Deficient Transferrin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
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.