Cleared Traditional

K981084 - URISCREEN

K981084 is an FDA 510(k) clearance for URISCREEN, manufactured by Diatech Diagnostics,Inc.. The device is a Class 1 Microbiology device with product code JXA cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K981084 · Diatech Diagnostics,Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K981084

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 102d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

JXA Device Classification - Class 1, General Controls

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.

Regulatory Peers - JXA Kit, Screening, Urine

All 27
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K981084.
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043 · Osmetech · Nov 2001
URINE SCREENING DEVICE
K972676 · Combact Diagnostic Systems , Ltd. · Feb 1998
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
K952246 · Tri-Tech, Inc. · Jun 1995
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
K950257 · Izon Business Products, Inc. · Apr 1995
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K950221 · Izon Business Products, Inc. · Mar 1995
MULTIPLE (IZON URINE COLLECTION KIT)
K950246 · Izon Business Products, Inc. · Mar 1995
K981084 · URISCREEN
Download PDF FDA Summary Diatech Diagnostics,I…