Cleared Traditional

K232404 - CHOLESTEROL

Also marketed or referenced as:
HDL-cholesterol LDL-cholesterol TRIGLYCERIDES

K232404 is an FDA 510(k) clearance for CHOLESTEROL, manufactured by Medicon Hellas S.A. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 365-day FDA review.

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

FDA 510(k) Submission Details - K232404

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.

CHH Device Classification - Class 1, General Controls

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.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 140
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K232404.
Lipids
K251091 · Truvian Health · Dec 2025
Cholesterol2
K203597 · Abbott Ireland Diagnostics Division · Jun 2022
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
Extended Lipid Panel Assay
K181373 · Laboratory Corporation of America Holdings · Oct 2018
Mission Lipid Panel Monitoring System
K180504 · ACON Laboratories, Inc. · Mar 2018
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · ACON Laboratories, Inc. · Jul 2017