Cleared Traditional

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834) - FDA 510(k) Clearance

Class I Chemistry device.

K991834 · Cholestech Corp. · Chemistry device
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Sep 1999
Decision
104d
Days
Class 1
Risk

K991834 is an FDA 510(k) clearance for the CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772. Classified as Hydrazone Colorimetry, Alt/sgpt (product code CKD), Class I - General Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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.

View all Cholestech Corp. devices

Submission Details

510(k) Number K991834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date September 09, 1999
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKD Hydrazone Colorimetry, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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.