Cleared Traditional

K012397 - URISYS 2400 URINE TEST STRIP

K012397 is the FDA 510(k) clearance for URISYS 2400 URINE TEST STRIP by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K012397 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2001
Decision
61d
Days
Class 2
Risk

K012397 is an FDA 510(k) clearance for the URISYS 2400 URINE TEST STRIP. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 26, 2001 after a review of 61 days - a notably fast clearance 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: 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K012397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2001
Decision Date September 26, 2001
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
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 K012397.
FORESIGHT U120 URINE ANALYZER
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K032437 · Roche Diagnostics Corp. · Oct 2003
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K896454 · Boehringer Mannheim Corp. · Jan 1990
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · Behring Diagnostics, Inc. · Oct 1986
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · Miles Laboratories, Inc. · Sep 1983