510(k) Report

510(k) · Cleared

Cleared

Roche Reagent for Creatinine

K941837510(k) TraditionalCleared Aug 26, 1994135-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

Roche Diagnostic Systems, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine

Cleared on Aug 26, 1994 after a 135-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Aug 26, 1994
Review
135 days
Class
Class II
Product code
CGX
Recalls
None
Predicates
0

19 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2006: 2 descendants cleared1998: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2017: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2008: 1 descendant cleared2021: 1 descendant cleared2019: 2 descendants cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK941837 Roche Reagent for CreatinineRoche Diagnostic Systems, Inc. · 1994
  2. Descendant · cites it directly · 11 of its ownK070249 Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase…Horiba Abx · 2007 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK070146 Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007
  4. Descendant · 2 generations on · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
  5. Descendant · 3 generations on · 2 of its ownK081276 Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine…Horiba Abx · 2008 · Recalled
  6. Descendant · cites it directly · 2 of its ownK061193 CreatinineAbbott Laboratories, Inc. · 2006

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1998: 12005: 12006: 22007: 32008: 12009: 12011: 22012: 12013: 12015: 12017: 12019: 22021: 12022: 1
1998high 3 (2007) · low 0 (1999)2026

Most influential descendants

Showing 5 of 19 · See all
  • K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx · 2007 · cites it directly11descendants
  • K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007 · 2 generations on3descendants
  • K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · 2 generations on2descendants
  • K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 2008 · 3 generations on2descendants
  • K061193CreatinineAbbott Laboratories, Inc. · 2006 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941837Roche Reagent for CreatinineRoche Diagnostic Systems, Inc.1994—
+1K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine…Horiba Abx20071
+2K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx2007—
+2K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical…Horiba Abx Sas2013—
+3K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx20081
+1K061193CreatinineAbbott Laboratories, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200510
200620
200730
200810
200910
201120
201210
201310
201510
201710
201920
202110
202210
FIG. 1 — Lineage of K941837, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CGX? 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 CGX device

  1. #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 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? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx200711
K061193CreatinineAbbott Laboratories, Inc.20062
K083809CreatinineAbbott Laboratories20091
K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20061
K050283Creatinine LiquicolorStanbio Laboratory20051
K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx20070
K981240Creatinine (Crea)Abbott Laboratories19980

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?

  • Of its descendants, K070249 (Horiba Abx, 2007) has gone furthest, with 11 descendants of its own.

How does its category compare?

All CGX devices

CGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGX

1in 2025

2007: 42009: 12012: 12013: 12014: 22016: 12022: 12024: 22025: 12026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGX

25in 2007

2007: 25 days median
2007high 25 (2007)2026

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

Recalls per year · CGX

2in 2016

2008: 12009: 22010: 22011: 12012: 22016: 22026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CGX

34in 2025

2007: 152008: 272009: 52010: 52011: 322012: 132013: 242014: 132015: 132016: 32017: 212018: 142019: 252020: 192021: 132022: 232023: 192024: 322025: 34
2007high 34 (2025) · low 3 (2016)2025

MAUDE reports naming product code CGX, 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
2007425015
20080—127
20091—25
20100—25
20110—132
20121—213
20131—024
20142—013
20150—013
20161—23
20170—021
20180—014
20190—025
20200—019
20210—013
20221—023
20230—019
20242—032
20251—034
20261—1—

More from Roche Diagnostic Systems, Inc.

296 FDA decisions under this applicant name. See the company

  • K983698Modification to Abuscreen Online BarbituratesRoche Diagnostic Systems, Inc. · 1999
  • K983702Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
  • K983704Modification to Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1999
  • K983556Abuscreen Online Benz 300 CalibratorsRoche Diagnostic Systems, Inc. · 1998
  • K983555Abuscreen Online Benz 200 CalibratorsRoche Diagnostic Systems, Inc. · 1998

Recent decisions in CGX

The CGX category page

  • K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2026
  • K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
  • K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024
  • K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  • K210452Creatinine2Abbott Ireland Diagnostics Division · 2022

https://510kreport.com/device/K941837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941837: Roche Reagent for Creatinine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941837

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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