Cleared Traditional

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS (K052525) - FDA 510(k) Clearance

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

K052525 · DFI Co., Ltd. · Chemistry device
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Mar 2006
Decision
196d
Days
Class 2
Risk

K052525 is an FDA 510(k) clearance for the CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by DFI Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 196 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 DFI Co., Ltd. devices

Submission Details

510(k) Number K052525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date March 29, 2006
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 16
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K052525.
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024 · DFI Co., Ltd. · May 2018
DUS R-50S (Urine Chemistry system)
K171521 · DFI Co., Ltd. · Feb 2018
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · Siemens Healthcare Diagnostics · Oct 2009
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
URISYS 2400 URINE TEST STRIP
K012397 · Roche Diagnostics Corp. · Sep 2001
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990