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)
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.

View all Dirui Industrial Co., Ltd. devices

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
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

Devices cleared under the same product code (JIO) and FDA review panel - the closest regulatory comparables to K040703.
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
K232317 · Urit Medical Electronic Co., Ltd. · Apr 2024
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
K111999 · Healgen Scientific, LLC · Apr 2012
MISSION U500 URINE ANALYZER
K111221 · ACON Laboratories, Inc. · Jan 2012
URS-1B (BLOOD TEST)
K023297 · Teco Diagnostics · Mar 2003
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
K913005 · Remel Co. · Sep 1991
HEMASTIX REAGENT STRIPS
K905396 · Heraeus Kulzer, Inc. · Feb 1991