510(k) · Cleared

Cleared

Myoglobin Control Set

K973358510(k) TraditionalCleared Oct 6, 199728-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

Boehringer Mannheim Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Oct 6, 1997 as substantially equivalent to K902154 (Behring Diagnostics, Inc., 1990) after a 28-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Oct 6, 1997
Review: 28 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K902154 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
This deviceK973358 Myoglobin Control SetBoehringer Mannheim Corp. · 1997
Descendant · cites it directly · 0 of its ownK123785 Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013

Most influential descendants

Showing 1 of 1 · See all

K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902154	NA Latex Myoglobin Test	Behring Diagnostics, Inc.	1990	—
0 (this device)	K973358	Myoglobin Control Set	Boehringer Mannheim Corp.	1997	—
+1	K123785	Diazyme Myoglobin; Assay, Calibrator Set, Control Set	Diazyme Laboratories	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K973358, 1990–2013Source: 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
*	K902154	NA Latex Myoglobin Test Summary page 1 …commercial distribution intended for similar use. Most notably it is substantially equivalent to the myoglobin controls contained in the Behring N Latex Myoglobin assay (K902154). The Boehringer Mannheim Myoglobin Controls are manufactured using human serum albumin, Myoglobin, and stabilizers. The analyte…	Behring Diagnostics, Inc.	1990	—

Also cleared against K902154: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K123785	Diazyme Myoglobin; Assay, Calibrator Set, Control Set	Diazyme Laboratories	2013	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?

Its one ancestor has no recall.
Of its descendants, K123785 (Diazyme Laboratories, 2013) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K902154.

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?

The Myoglobin Control Set are used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant Myoglobin assay.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973358 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973358: Myoglobin Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973358

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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