510(k) · Cleared

Cleared

Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927

K071215510(k) SpecialCleared May 25, 200723-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

Ortho-Clinical Diagnostics, Inc. · JFY Enzymatic Method, Creatinine

Cleared on May 25, 2007 as substantially equivalent to K934071 (Eastman Kodak Company, 1994) after a 23-day review. Its family tree reaches back 1 generation to 1994.

Decided: May 25, 2007
Review: 23 days
Class: Class II
Product code: JFY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934071 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK934071 Kodak Ektachem DT Slides (Urcr)Eastman Kodak Company · 1994 · Recalled
This deviceK071215 Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934071	Kodak Ektachem DT Slides (Urcr)	Eastman Kodak Company	1994	1
0 (this device)	K071215	Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator…	Ortho-Clinical Diagnostics, Inc.	2007	—

FIG. 1 — Lineage of K071215, 1994–2007Source: 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
*	K934071	Kodak Ektachem DT Slides (Urcr) Summary page 1 …. The FDA cleared the VITROS Chem- istry Products urCR DT Slides and VITROS Chemistry Products DT Calibra- tor Kit on March 21, 1994 (K934071) under the following product names: KODAK EKTACHEM DT SLIDES (urCR) and KODAK EKTACHE…	Eastman Kodak Company	1994	1

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 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. 2007, 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?

For in vitro diagnostic use only.

VITROS urCR DT Slides quantitatively measure creatinine concentration in urine on the DT60/DT60 II analyzer.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

For in vitro diagnostic use only.

VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, C02, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071215 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071215: Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071215

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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