Cleared Traditional

K082811 - URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.