Cleared Traditional

K232404 - CHOLESTEROL (FDA 510(k) Clearance)

Also includes:
HDL-cholesterol LDL-cholesterol TRIGLYCERIDES

Class I Chemistry device.

K232404 · Medicon Hellas S.A · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
365d
Days
Class 1
Risk

K232404 is an FDA 510(k) clearance for the CHOLESTEROL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Medicon Hellas S.A (Gerakas, GR). The FDA issued a Cleared decision on August 9, 2024 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 Medicon Hellas S.A devices

Submission Details

510(k) Number K232404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2023
Decision Date August 09, 2024
Days to Decision 365 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
277d slower than avg
Panel avg: 88d · This submission: 365d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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.