Cleared Traditional

K864202 - UTISCREEN BACTERIAL ATP TEST

K864202 is the FDA 510(k) clearance for UTISCREEN BACTERIAL ATP TEST by Los Alamos Diagnostics. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K864202 · Los Alamos Diagnostics · Microbiology device
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Feb 1987
Decision
109d
Days
Class 1
Risk

K864202 is an FDA 510(k) clearance for the UTISCREEN(R) BACTERIAL ATP TEST. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Los Alamos Diagnostics (Los Alamos, US). The FDA issued a Cleared decision on February 13, 1987 after a review of 109 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.

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Submission Details

510(k) Number K864202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date February 13, 1987
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
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.

Regulatory Peers - JXA Kit, Screening, Urine

All 11
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K864202.
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · Gen-Probe, Inc. · Sep 1989
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc. · Jun 1986
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984