Cleared Traditional

URISCREEN (K981084) - FDA 510(k) Clearance

Class I Microbiology device.

K981084 · Diatech Diagnostics,Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
196d
Days
Class 1
Risk

K981084 is an FDA 510(k) clearance for the URISCREEN. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Diatech Diagnostics,Inc. (Beverly, US). The FDA issued a Cleared decision on October 7, 1998 after a review of 196 days - an extended review cycle.

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 Diagnostics,Inc. devices

Submission Details

510(k) Number K981084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1998
Decision Date October 07, 1998
Days to Decision 196 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 102d · This submission: 196d
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.