510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Cobas Integra Creatinine Plus Ver.2 Assay

K024098510(k) SpecialCleared Dec 19, 20027-day reviewClass II21 CFR 862.1225Recalls 2

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

Roche Diagnostics Corp. · JFY Enzymatic Method, Creatinine

Cleared on Dec 19, 2002 as substantially equivalent to K003261 (Roche Diagnostics Corp., 2000) after a 7-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it. It has been recalled 2 times.

Decided
Dec 19, 2002
Review
7 days
Class
Class II
Product code
JFY
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K003261 (2000). 7 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant clearedK003261 · Creatinine Plus · Roche Diagnostics Corp. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 2 descendants K003261 · Creatinine Plus · Roche Diagnostics Corp. · 2000 · recalled0
  1. Root · 1 generation backK003261 Creatinine PlusRoche Diagnostics Corp. · 2000 · Recalled
  2. This deviceK024098 Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp. · 2002
  3. Descendant · cites it directly · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
  4. Descendant · cites it directly · 1 of its ownK113726 Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012
  5. Descendant · 2 generations on · 0 of its ownK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
  6. Descendant · 2 generations on · 0 of its ownK200107 epoc Blood Analysis SystemEpocal, Inc. · 2020 · Recalled
  7. Descendant · cites it directly · 0 of its ownK132399 Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and…Elitechgroup · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 12011: 12012: 12014: 12019: 12020: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · cites it directly1descendant
  • K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012 · cites it directly1descendant
  • K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023 · 2 generations on0descendants
  • K200107epoc Blood Analysis SystemEpocal, Inc. · 2020 · 2 generations on0descendants
  • K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003261Creatinine PlusRoche Diagnostics Corp.20001
0 (this device)K024098Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp.2002—
+1K183555GEM Premier ChemSTATInstrumentation Laboratory CO2019—
+1K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.2012—
+2K223090GEM Premier ChemSTATInstrumentation Laboratory CO2023—
+2K200107epoc Blood Analysis SystemEpocal, Inc.202019
+1K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol…Elitechgroup2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
201210
201410
201910
202010
202310
FIG. 1 — Lineage of K024098, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K003261Creatinine Plus
Summary page 1
…serum, plasma, and urine. Predicate We claim substantial equivalence to the currently marketed COBAS Integra Device Creatinine plus Assay. (K003261). 24 continued…
Roche Diagnostics Corp.20001

Also cleared against K003261: 5 other devices →

What descends from it? (7)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191
K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.20121
K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140
K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110
K070824Creatinine (Enzymatic)Thermofisher Scientific OY20070

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 14, 2018Class IIZ-1125-2019Device DesignCOBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Jun 11, 2008Not classifiedZ-0008-2009Labeling Change ControlSome of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K183555 (Instrumentation Laboratory CO, 2019) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K003261.

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

2007: 82008: 42009: 32011: 22014: 22016: 12017: 12018: 22019: 22021: 22026 (partial year): 1
2007high 8 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFY

59in 2009

2007: 193 days median2008: 170 days median2009: 59 days median
2007high 193 (2007) · low 59 (2009)2026

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

Recalls per year · JFY

1in 2013

2008: 22009: 32010: 32013: 1
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

2007: 12008: 42009: 222010: 222011: 422012: 242013: 392014: 42015: 72016: 162017: 162018: 342019: 562020: 342021: 572022: 92023: 362024: 342025: 61
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007819301
2008417024
2009359322
20100—322
20112—042
20120—024
20130—139
20142—04
20150—07
20161—016
20171—016
20182—034
20192—056
20200—034
20212—057
20220—09
20230—036
20240—034
20250—061
20261—0—

What is it indicated for?

The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Indications for use as stated in the FDA summary.

Also cleared against K003261

5 other devices cite the same predicate.

  • K090330Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine Calibrator, Models…Siemens Healthcare Diagnostics, Inc. · 20095 recalls
  • K073634Multigent Creatinine (Enzymatic) AssaySENTINEL CH. SpA · 20081 recall
  • K073055Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270Dade Behring, Inc. · 20085 recalls
  • K070383Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd. · 20072 recalls
  • K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

Recent decisions in JFY

The JFY category page

  • K252619Qscheck UisacrQstag, Inc. · 2026
  • K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc. · 2021
  • K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021
  • K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019

https://510kreport.com/device/K024098 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024098: Cobas Integra Creatinine Plus Ver.2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024098

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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