Cleared Traditional

K210452 - Creatinine2 (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210452 · Abbott Ireland Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
399d
Days
Class 2
Risk

K210452 is an FDA 510(k) clearance for the Creatinine2. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on March 22, 2022 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Abbott Ireland Diagnostics Division devices

Submission Details

510(k) Number K210452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2021
Decision Date March 22, 2022
Days to Decision 399 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
311d slower than avg
Panel avg: 88d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 158
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K210452.
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K242685 · Siemens Healthcare Diagnostics, Inc. · Dec 2024
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K221813 · Nova Biomedical Corporation · Nov 2024