Cleared Dual Track

K223179 - Cholestech LDX System

K223179 is an FDA 510(k) clearance for Cholestech LDX System, manufactured by Alere San Diego, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Dual Track 510(k) pathway after a 344-day FDA review.

K223179 · Alere San Diego, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2023
Decision
344d
Days
Class 2
Risk

K223179 is an FDA 510(k) clearance for the Cholestech LDX ™ System. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Alere San Diego, Inc. (San Diego, US). The FDA issued a Cleared decision on September 20, 2023 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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. Elevated predicate reliance profile. 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 Alere San Diego, Inc. devices

FDA 510(k) Submission Details - K223179

510(k) Number K223179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2022
Decision Date September 20, 2023
Days to Decision 344 days
Submission Type Dual Track
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
256d slower than avg
Panel avg: 88d · This submission: 344d
Pathway characteristics

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 231
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