Cleared Traditional

URISCREEN (K882211) - FDA 510(k) Clearance

Class I Microbiology device.

K882211 · Diatech Diagnostica , Ltd. · Microbiology device
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Sep 1988
Decision
127d
Days
Class 1
Risk

K882211 is an FDA 510(k) clearance for the URISCREEN. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Diatech Diagnostica , Ltd. (Washington, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diatech Diagnostica , Ltd. devices

Submission Details

510(k) Number K882211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1988
Decision Date September 30, 1988
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 102d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.