510(k) · Cleared

Cleared

Precinorm CK-MB and Precipath CK-MB Controls

K062972510(k) SpecialCleared Oct 13, 200614-day reviewClass I21 CFR 862.1660

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

Roche Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Oct 13, 2006 as substantially equivalent to K003158 (Roche Diagnostics Corp., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000.

Decided: Oct 13, 2006
Review: 14 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003158 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003158 Roche Diagnostics CK-MBRoche Diagnostics Corp. · 2000
This deviceK062972 Precinorm CK-MB and Precipath CK-MB ControlsRoche Diagnostics Corp. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003158	Roche Diagnostics CK-MB	Roche Diagnostics Corp.	2000	—
0 (this device)	K062972	Precinorm CK-MB and Precipath CK-MB Controls	Roche Diagnostics Corp.	2006	—

FIG. 1 — Lineage of K062972, 2000–2006Source: 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 JJX? 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

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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
*	K003158	Roche Diagnostics CK-MB Summary page 1 …e Modification to provide notification of modifications to our Precinorm CK- MB Control. This control was originally cleared for use in K003 158, along with a CK-MB reagent and calibrator system on Roche/Hitachi Analyzers. Modifications to…	Roche Diagnostics Corp.	2000	—

Also cleared against K003158: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
5 other devices also cite its predicate K003158.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062972 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062972: Precinorm CK-MB and Precipath CK-MB Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062972

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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