Cleared Traditional

K032027 - CHOLESTECH LDX ASPARTATE AMINOTRANSFERA...

K032027 is an FDA 510(k) clearance for CHOLESTECH LDX ASPARTATE AMINOTRANSFERA..., manufactured by Cholestech Corp.. The device is a Class 2 Chemistry device with product code CIS cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K032027 · Cholestech Corp. · Chemistry device
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Sep 2003
Decision
66d
Days
Class 2
Risk

K032027 is an FDA 510(k) clearance for the CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST). Classified as Hydrazone Colorimetry, Ast/sgot (product code CIS), Class II - Special Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 Cholestech Corp. devices

FDA 510(k) Submission Details - K032027

510(k) Number K032027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2003
Decision Date September 05, 2003
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIS Device Classification - Class 2, Special Controls

Product Code CIS Hydrazone Colorimetry, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIS Hydrazone Colorimetry, Ast/sgot

Devices cleared under the same product code (CIS) and FDA review panel - the closest regulatory comparables to K032027.
COBAS READY AST REAGENT
K896238 · Roche Diagnostic Systems, Inc. · Feb 1990
IN-VITRO TEST DETERMINATION OF SGOT (AST)
K854187 · Clinical Data, Inc. · Nov 1985
OPTIONAL TOTAL CA-MODULE FOR IL 504/508
K812872 · Instrumentation Laboratory CO · Oct 1981
ELVI SGOT & SGPT TRANSAMINASE
K792410 · Volu Sol Medical Industries · Dec 1979