Cleared Dual Track

K223179 - Cholestech LDX ™ System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K223179 · Alere San Diego, Inc. · Chemistry device
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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

Submission Details

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

Device Classification

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.

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