Cleared Traditional

K210452 - Creatinine2

K210452 is an FDA 510(k) clearance for Creatinine2, manufactured by Abbott Ireland Diagnostics Division. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 399-day FDA review.

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

FDA 510(k) Submission Details - K210452

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.

CGX Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K210452.
Tru Kidney Health Test Panel
K251058 · Truvian Health · Nov 2025
Atellica® CH Creatinine_3 (Crea3)
K242685 · Siemens Healthcare Diagnostics, Inc. · Dec 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · Nova Biomedical Corporation · Nov 2024
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494 · Siemens Healthcare Diagnostics, Inc. · Nov 2016
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728 · Siemens Healthcare Diagnostics, Inc. · Jan 2014