510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Creatinine Plus

K003261510(k) SpecialCleared Nov 16, 200029-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

Roche Diagnostics Corp. · JFY Enzymatic Method, Creatinine

Cleared on Nov 16, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it. It has been recalled once.

Decided
Nov 16, 2000
Review
29 days
Class
Class II
Product code
JFY
Recalls
1
Predicates
0

15 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2007: 3 descendants cleared2008: 2 descendants cleared2002: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2011: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK003261 Creatinine PlusRoche Diagnostics Corp. · 2000
  2. Descendant · cites it directly · 7 of its ownK024098 Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp. · 2002 · Recalled
  3. Descendant · cites it directly · 2 of its ownK070383 Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd. · 2007 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
  5. Descendant · 2 generations on · 1 of its ownK113726 Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012
  6. Descendant · 2 generations on · 1 of its ownK110137 Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2011 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2002: 12007: 32008: 22009: 12011: 22012: 12014: 12019: 12020: 12021: 12023: 1
2002high 3 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 15 · See all
  • K024098Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp. · 2002 · cites it directly7descendants
  • K070383Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd. · 2007 · cites it directly2descendants
  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · 2 generations on1descendant
  • K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012 · 2 generations on1descendant
  • K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas · 2011 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003261Creatinine PlusRoche Diagnostics Corp.2000—
+1K024098Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp.20022
+1K070383Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd.20072
+2K183555GEM Premier ChemSTATInstrumentation Laboratory CO2019—
+2K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.2012—
+2K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control…Horiba Abx Sas20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200730
200820
200910
201120
201210
201410
201910
202010
202110
202310
FIG. 1 — Lineage of K003261, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K024098Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp.20027
K070383Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd.20072
K090330Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine…Siemens Healthcare Diagnostics, Inc.20090
K073634Multigent Creatinine (Enzymatic) AssaySENTINEL CH. SpA20080
K073055Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270Dade Behring, Inc.20080
K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories20070

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

Recalls of this device

DateClassRecallRoot causeReason
May 7, 2015Class IIZ-1923-2015Under Investigation by firmPossible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only)…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K024098 (Roche Diagnostics Corp., 2002) has gone furthest, with 7 descendants of its own.

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—

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/K003261 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003261: Creatinine Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003261

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026