510(k) · Cleared

Cleared

Careside Creatinine

K980043510(k) TraditionalCleared Mar 30, 199883-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

Exigent Diagnostics, Inc. · JFY Enzymatic Method, Creatinine

Cleared on Mar 30, 1998 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after an 83-day review. Its family tree reaches back 1 generation to 1991.

Decided: Mar 30, 1998
Review: 83 days
Class: Class II
Product code: JFY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
This deviceK980043 Careside CreatinineExigent Diagnostics, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912844	Kodak Ektachem Dtii System	Eastman Kodak Company	1991	—
0 (this device)	K980043	Careside Creatinine	Exigent Diagnostics, Inc.	1998	—

FIG. 1 — Lineage of K980043, 1991–1998Source: 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

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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
*	K912844	Kodak Ektachem Dtii System Summary page 1 …tinan Kodak, Inc.) Vitres CREA Slides (blank corrected method) for Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak’s DT 60 IT). Predicate Device S10K number: K912844/A Product Code: 7S5ILA FROM : EXIGENT DIAGNOSTICS INC. PHONE NO. : 3183386789 Mar. 23 1998 18:84AM P8 Exigent Di…	Eastman Kodak Company	1991	—

Also cleared against K912844: 28 other devices →

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?

Its one ancestor has no recall.
28 other devices also cite its predicate K912844.

How does its category compare?

All JFY devices

JFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure creatinine in whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of renal diseases.

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/K980043 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980043: Careside Creatinine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980043

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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