510(k) · Cleared
ClearedUritek TC-201 Urine Chemistry Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics, Inc. · JFY Enzymatic Method, Creatinine
Cleared on Mar 7, 2016 as substantially equivalent to K091216 (Siemens Healthcare Diagnostics, 2009) after a 160-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Mar 7, 2016
- Review
- 160 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905396 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 2 generations backK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- This deviceK152835 Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −2 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| 0 (this device) | K152835 | Uritek TC-201 Urine Chemistry Test System | Teco Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
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 JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Summary page 5…REDICATE DEVICE Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis SIEMMENS HEALTHCARE DIAGNOSTICS 2 Edgewater Dr. Norwood, MA 02062 510(k) Number: k091216 IV. DEVICE DESCRIPTION Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbum… | 2009 |
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K091216.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the…
Read the full statement (111 words)
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semi-quantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152835 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152835: Uritek TC-201 Urine Chemistry Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152835
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026