Cleared Traditional

K032437 - CHEMSTRIP 5 OB

K032437 is the FDA 510(k) clearance for CHEMSTRIP 5 OB by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K032437 · Roche Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
62d
Days
Class 2
Risk

K032437 is an FDA 510(k) clearance for the CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS. 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 October 8, 2003 after a review of 62 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 K032437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2003
Decision Date October 08, 2003
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 K032437.
DUS R-50S (Urine Chemistry system)
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K091216 · Siemens Healthcare Diagnostics · Oct 2009
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
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · Behring Diagnostics, Inc. · Oct 1986