510(k) · Cleared

Cleared

Roche Diagnostics CK-MB

K003158510(k) TraditionalCleared Dec 18, 200069-day reviewClass II21 CFR 862.1215

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

Roche Diagnostics Corp. · JHW U.V. Method, Cpk Isoenzymes

Cleared on Dec 18, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided: Dec 18, 2000
Review: 69 days
Class: Class II
Product code: JHW
Recalls: None
Predicates: 0

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

This deviceK003158 Roche Diagnostics CK-MBRoche Diagnostics Corp. · 2000
Descendant · cites it directly · 3 of its ownK081731 Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent…Siemens Healthcare Diagnostics · 2008 · Recalled
Descendant · 2 generations on · 1 of its ownK083579 Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009
Descendant · cites it directly · 0 of its ownK162526 Creatine Kinase-MBRoche Diagnostics · 2017
Descendant · 3 generations on · 0 of its ownK160724 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
Descendant · cites it directly · 0 of its ownK123977 Randox Liquid CK-MB, Randox CK-MB CalibratorRandox Laboratories, Ltd. · 2013

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006high 2 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 9 · See all

K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Siemens Healthcare Diagnostics · 2008 · cites it directly3descendants
K083579Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009 · 2 generations on1descendant
K162526Creatine Kinase-MBRoche Diagnostics · 2017 · cites it directly0descendants
K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc. · 2016 · 3 generations on0descendants
K123977Randox Liquid CK-MB, Randox CK-MB CalibratorRandox Laboratories, Ltd. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003158	Roche Diagnostics CK-MB	Roche Diagnostics Corp.	2000	—
+1	K081731	Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge…	Siemens Healthcare Diagnostics	2008	1
+2	K083579	Dimension Vista System Enzyme 6 Calibrator, Model KC360	Siemens Healthcare Diagnostics	2009	—
+1	K162526	Creatine Kinase-MB	Roche Diagnostics	2017	—
+3	K160724	ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3…	Siemens Healthcare Diagnostics, Inc.	2016	2
+1	K123977	Randox Liquid CK-MB, Randox CK-MB Calibrator	Randox Laboratories, Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2013	1	0
2016	1	0
2017	1	0

FIG. 1 — Lineage of K003158, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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? (9)

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

Number	Device	Applicant	Decided	Descendants
K081731	Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…	Siemens Healthcare Diagnostics	2008	3
K162526	Creatine Kinase-MB	Roche Diagnostics	2017	0
K123977	Randox Liquid CK-MB, Randox CK-MB Calibrator	Randox Laboratories, Ltd.	2013	0
K102706	CKMB Udr Assay	SENTINEL CH. SpA	2011	0
K101456	Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator…	Roche Diagnostics	2010	0
K062972	Precinorm CK-MB and Precipath CK-MB Controls	Roche Diagnostics Corp.	2006	0

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, K081731 (Siemens Healthcare Diagnostics, 2008) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JHW devices

JHW U.V. Method, Cpk Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHW

1in 2017

2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHW

Too few JHW 510(k)s in any year since 2007 to give a median.

Recalls per year · JHW

No recall names JHW since 2007.

Adverse event reports per year · JHW

1in 2024

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code JHW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	1
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	1
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K003158 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003158: Roche Diagnostics CK-MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003158

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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