Cleared Traditional

K091742 - SYNCHRON SYSTEMS ENZYMATIC CREATININE (...

K091742 is the FDA 510(k) clearance for SYNCHRON SYSTEMS ENZYMATIC CREATININE (... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JFY) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K091742 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
59d
Days
Class 2
Risk

K091742 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 14, 2009 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K091742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date August 14, 2009
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFY Enzymatic Method, 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 - JFY Enzymatic Method, Creatinine

All 30
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K091742.
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
K182063 · Ortho-Clinical Diagnostics, Inc. · Oct 2018
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
K142391 · ACON Laboratories, Inc. · Dec 2014
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K093458 · Beckman Coulter, Inc. · Dec 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
K090330 · Siemens Healthcare Diagnostics, Inc. · May 2009
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · Dade Behring, Inc. · Jan 2008
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383 · Diagnostic Chemicals , Ltd. · Jun 2007