Cleared Traditional

K991834 - CHOLESTECH LDX ALANINE AMINOTRANSFERASE...

K991834 is an FDA 510(k) clearance for CHOLESTECH LDX ALANINE AMINOTRANSFERASE..., manufactured by Cholestech Corp.. The device is a Class 1 Chemistry device with product code CKD cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K991834 · Cholestech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K991834

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

CKD Device Classification - Class 1, General Controls

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.

Regulatory Peers - CKD Hydrazone Colorimetry, Alt/sgpt

All 8
Devices cleared under the same product code (CKD) and FDA review panel - the closest regulatory comparables to K991834.
ORTHO ALT MICROWELL TEST SYSTEM
K941192 · Ortho Diagnostic Systems, Inc. · May 1995
COBAS READY ALT REAGENT
K896237 · Roche Diagnostic Systems, Inc. · Feb 1990
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387 · Tech-Co, Inc. · Oct 1988
REFLOTRON(R) ALT (GPT)
K864082 · Boehringer Mannheim Corp. · Dec 1986
SGPT (ALT) REAGENT SET (COLORIMETRIC)
K860485 · Sterling Diagnostics, Inc. · Apr 1986
SGPT REAGENT SET
K841059 · Medical Specialties, Inc. · May 1984