Cleared Traditional

K082811 - URITEST 10G & 11G URINE REAGENT STRIPS ...

K082811 is an FDA 510(k) clearance for URITEST 10G & 11G URINE REAGENT STRIPS ..., manufactured by Urit Medical Electronic Co., Ltd.. The device is a Class 2 Chemistry device with product code JIO cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K082811 · Urit Medical Electronic Co., Ltd. · Chemistry device
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Sep 2009
Decision
352d
Days
Class 2
Risk

K082811 is an FDA 510(k) clearance for the URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE .... Classified as Blood, Occult, Colorimetric, In Urine (product code JIO), Class II - Special Controls.

Submitted by Urit Medical Electronic Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 11, 2009 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Urit Medical Electronic Co., Ltd. devices

FDA 510(k) Submission Details - K082811

510(k) Number K082811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2008
Decision Date September 11, 2009
Days to Decision 352 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
264d slower than avg
Panel avg: 88d · This submission: 352d
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 K082811.
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
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K905396 · Heraeus Kulzer, Inc. · Feb 1991