Cleared Traditional

K040703 - URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS

K040703 is an FDA 510(k) clearance for URISTIK H SERIES REAGENT STRIPS FOR URI..., manufactured by Dirui Industrial Co., Ltd.. The device is a Class 2 Chemistry device with product code JIO cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K040703 · Dirui Industrial Co., Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
162d
Days
Class 2
Risk

K040703 is an FDA 510(k) clearance for the URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS. Classified as Blood, Occult, Colorimetric, In Urine (product code JIO), Class II - Special Controls.

Submitted by Dirui Industrial Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on August 26, 2004 after a review of 162 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - 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.

FDA 510(k) Submission Details - K040703

510(k) Number K040703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date August 26, 2004
Days to Decision 162 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
74d slower than avg
Panel avg: 88d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIO Device Classification - Class 2, Special Controls

Product Code JIO Blood, Occult, Colorimetric, In Urine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 - JIO Blood, Occult, Colorimetric, In Urine

All 10
Devices cleared under the same product code (JIO) and FDA review panel - the closest regulatory comparables to K040703.
MISSION U500 URINE ANALYZER
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K083724 · Wiener Laboratorios Saic · Sep 2009
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K023297 · Teco Diagnostics · Mar 2003
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K921495 · Symcon Intl., Inc. · Jul 1992
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K913005 · Remel Co. · Sep 1991
K040703 · URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
Download PDF FDA Summary Dirui Industrial Co.,…