510(k) · Cleared

Cleared

Teco Creatinine Enzymatic Reagent Kit

K161527510(k) TraditionalCleared Jul 21, 2017414-day reviewClass II21 CFR 862.1225

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

Teco Diagnostics, Inc. · JFY Enzymatic Method, Creatinine

Cleared on Jul 21, 2017 as substantially equivalent to K050283 (Stanbio Laboratory, 2005) after a 414-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jul 21, 2017
Review: 414 days
Class: Class II
Product code: JFY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K941837 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK941837 Roche Reagent for CreatinineRoche Diagnostic Systems, Inc. · 1994
1 generation backK050283 Creatinine LiquicolorStanbio Laboratory · 2005
This deviceK161527 Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941837	Roche Reagent for Creatinine	Roche Diagnostic Systems, Inc.	1994	—
−1	K050283	Creatinine Liquicolor	Stanbio Laboratory	2005	—
0 (this device)	K161527	Teco Creatinine Enzymatic Reagent Kit	Teco Diagnostics, Inc.	2017	—

FIG. 1 — Lineage of K161527, 1994–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K050283	Creatinine Liquicolor Summary page 6 …510(k) SUMMARY J. Substantial Equivalence Information: 1. Predicate device name(s): Stanbio Creatinine LiquiColor test system 2. Predicate K number(s): K050283 3. Compare with predicate: Table 5.1 Creatinine Enzymatic Reagent Kit vs Stanbio Creatinine LiquiColor test system…	Stanbio Laboratory	2005	—

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 23 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All JFY devices

JFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · JFY

2in 2021

2007high 8 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFY

59in 2009

2007high 193 (2007) · low 59 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JFY

1in 2013

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JFY

61in 2025

2007high 61 (2025) · low 1 (2007)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?

Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination or estimation of creatinine clearance or glomerular filtration rate (GFR).

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

https://510kreport.com/device/K161527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161527: Teco Creatinine Enzymatic Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161527

Report an extraction error

Are you the manufacturer?

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