Cleared Traditional

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (K013819) - FDA 510(k) Clearance

Class I Microbiology device.

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

Submission Details

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.

Device Classification

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 42
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K013819.
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
URINE CULTURE KIT
K790366 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1979
EPTONE BACK-UP BROTH, VACUTAINER
K771058 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1977
BOTTLE, BLOOD CULTURE, SCHAEDLER
K760458 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1976
CULTURE TUBE, (VACUTAINER)
K760054 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976