Cleared Traditional

K203597 - Cholesterol2 (FDA 510(k) Clearance)

Class I Chemistry device.

K203597 · Abbott Ireland Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
568d
Days
Class 1
Risk

K203597 is an FDA 510(k) clearance for the Cholesterol2. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on June 30, 2022 after a review of 568 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abbott Ireland Diagnostics Division devices

Submission Details

510(k) Number K203597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date June 30, 2022
Days to Decision 568 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
480d slower than avg
Panel avg: 88d · This submission: 568d
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.