Cleared Traditional

K090330 - DIMENSION VISTA ENZYMATIC CREATININE FL...

K090330 is an FDA 510(k) clearance for DIMENSION VISTA ENZYMATIC CREATININE FL..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K090330 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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May 2009
Decision
101d
Days
Class 2
Risk

K090330 is an FDA 510(k) clearance for the DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CR.... Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 101 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K090330

510(k) Number K090330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date May 22, 2009
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K090330.
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
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K073055 · Dade Behring, Inc. · Jan 2008
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K070383 · Diagnostic Chemicals , Ltd. · Jun 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
K071215 · Ortho-Clinical Diagnostics, Inc. · May 2007