510(k) Report

510(k) · Cleared

Cleared

Urine Collection, Preservation and Transport System

K013819510(k) TraditionalCleared Feb 28, 2002104-day reviewClass I21 CFR 866.2900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sierra Diagnostic, LLC · JTW System, Transport, Aerobic

Cleared on Feb 28, 2002 as substantially equivalent to K935833 (Abbott Laboratories, 1996) and 1 other predicate after a 104-day review. Its family tree reaches back 1 generation to 1995.

Decided
Feb 28, 2002
Review
104 days
Class
Class I
Product code
JTW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K934622 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK934622 · LCX Chlamydia Trachomatis Assay · Abbott Laboratories · 199519961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K934622 · LCX Chlamydia Trachomatis Assay · Abbott Laboratories · 19950
  1. Root · 1 generation backK934622 LCX Chlamydia Trachomatis AssayAbbott Laboratories · 1995
  2. This deviceK013819 Urine Collection, Preservation and Transport SystemSierra Diagnostic, LLC · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934622LCX Chlamydia Trachomatis AssayAbbott Laboratories1995—
0 (this device)K013819Urine Collection, Preservation and Transport SystemSierra Diagnostic, LLC2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K013819, 1995–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K935833LCX Neisseria Gonorrhoeae Assay
Summary page 1
…imens for testing with the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays and referenced in the package inserts for the LCx® devices (See 510(k) Nos. K935833 (Neisseria gonorrhoeae) and K934622 (Chlamydia trachomatis)). IV. Description of Device The device is comprised of a urine coll…
Abbott Laboratories1996—
*K934622LCX Chlamydia Trachomatis Assay
Summary page 1
…x® Neisseria gonorrhoeae and Chlamydia trachomatis assays and referenced in the package inserts for the LCx® devices (See 510(k) Nos. K935833 (Neisseria gonorrhoeae) and K934622 (Chlamydia trachomatis)). IV. Description of Device The device is comprised of a urine collection cup containing of a nucleic a…
Abbott Laboratories1995—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.

How does its category compare?

All JTW devices

JTW System, Transport, Aerobic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTW

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JTW

Too few JTW 510(k)s in any year since 2007 to give a median.

Recalls per year · JTW

1in 2022

2009: 12018: 42022: 1
2007high 4 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JTW

36in 2025

2011: 22012: 22013: 12014: 32015: 22016: 22017: 142018: 322019: 82020: 122021: 72022: 52023: 222024: 372025: 36
2007high 37 (2024) · low 0 (2007)2025

MAUDE reports naming product code JTW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—10
20100—00
20110—02
20121—02
20130—01
20140—03
20150—02
20160—02
20170—014
20180—432
20190—08
20200—012
20210—07
20220—15
20230—022
20240—037
20250—036
20260—0—

What is it indicated for?

The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is indicated for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in JTW

The JTW category page

  • K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
  • K061301Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemCopan Diagnostics, Inc. · 2006
  • K022874Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2002
  • K993161Copan Easy-Swab Collection and Transport SystemCopan Diagnostics, Inc. · 19991 recall
  • K983244Sensititre 18-24 HR Susceptibility Plates (Addition of Meropenem)Trek Diagnostic Systems, Inc. · 19989 Class I recalls

https://510kreport.com/device/K013819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013819: Urine Collection, Preservation and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013819

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026