Cleared Traditional

K013819 - URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM

K013819 is an FDA 510(k) clearance for URINE COLLECTION, manufactured by Sierra Diagnostic, LLC. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K013819 · Sierra Diagnostic, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
104d
Days
Class 1
Risk

K013819 is an FDA 510(k) clearance for the URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Sierra Diagnostic, LLC (Washington, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Sierra Diagnostic, LLC devices

FDA 510(k) Submission Details - K013819

510(k) Number K013819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2001
Decision Date February 28, 2002
Days to Decision 104 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
2d slower than avg
Panel avg: 102d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 29
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K013819.
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
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K993161 · Copan Diagnostics, Inc. · Nov 1999
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
K983244 · Trek Diagnostic Systems, Inc. · Nov 1998
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · Difco Laboratories, Inc. · Apr 1996
CULTURESWAB TRANSPORT SYSTEM
K934894 · Difco Laboratories, Inc. · Feb 1994