510(k) · Cleared

Recalled · Class II · 2014

Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2721, 195 7927

K071216510(k) SpecialCleared May 25, 200723-day reviewClass II21 CFR 862.1225Recalls 1

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 K875191 (Eastman Kodak Company, 1988) after a 23-day review. Its family tree reaches back 1 generation to 1988. 5 later devices descend from it. It has been recalled once.

Decided: May 25, 2007
Review: 23 days
Class: Class II
Product code: JFY
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K875191 (1988). 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK875191 Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company · 1988
This deviceK071216 Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2007
Descendant · cites it directly · 4 of its ownK072443 Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
Descendant · 2 generations on · 3 of its ownK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
Descendant · 3 generations on · 2 of its ownK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009 · Recalled
Descendant · 4 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
Descendant · 5 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010

Most influential descendants

Showing 5 of 5 · See all

K072443Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssayOrtho-Clinical Diagnostics, Inc. · 2007 · cites it directly4descendants
K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2008 · 2 generations on3descendants
K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2009 · 3 generations on2descendants
K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 4 generations on1descendant
K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K875191	Kodak Ektachem DT Slides (CRSC)	Eastman Kodak Company	1988	—
0 (this device)	K071216	Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator…	Ortho-Clinical Diagnostics, Inc.	2007	—
+1	K072443	Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay	Ortho-Clinical Diagnostics, Inc.	2007	1
+2	K082099	Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…	Ortho-Clinical Diagnostics, Inc.	2008	—
+3	K083680	Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator…	Ortho-Clinical Diagnostics, Inc.	2009	1
+4	K091861	Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator…	Ortho-Clinical Diagnostics, Inc.	2009	—
+5	K093611	Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT…	Ortho-Clinical Diagnostics, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	2	0
2010	1	0

FIG. 1 — Lineage of K071216, 1988–2010Source: 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
*	K875191	Kodak Ektachem DT Slides (CRSC) Summary page 1 …The FDA cleared the VITROS Chemistry Products CRSC DT Slides on and VITROS Chemistry Products DT Calibrator Kit on February 24, 1988 (K875191) under the product names: KODAK EKTACHEM DT SLIDES (CRSC) and KODAK EKTACHEM DT Calibra…	Eastman Kodak Company	1988	—

Also cleared against K875191: 1 other device →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072443	Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay	Ortho-Clinical Diagnostics, Inc.	2007	4

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 29, 2014	Class II	Z-1490-2014	Process control	Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K072443 (Ortho-Clinical Diagnostics, Inc., 2007) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K875191.

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 Chemistry Products CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma 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, HIDLC, K+, LAC, LDH, LIPA, Mg, Na+, NIH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071216 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071216: Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2721, 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/K071216

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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