510(k) · Cleared

Recalled · Class II · 2018

Roche Diagnostics Tina-Quant Igm Gen.2

K040431510(k) SpecialCleared Mar 10, 200420-day reviewClass II21 CFR 866.5550Recalls 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. · DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control

Cleared on Mar 10, 2004 as substantially equivalent to K955908 (Boehringer Mannheim Corp., 1996) after a 20-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.

Decided: Mar 10, 2004
Review: 20 days
Class: Class II
Product code: DAO
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K955908 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK955908 Boehringer Mannheim Igm AssayBoehringer Mannheim Corp. · 1996
This deviceK040431 Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955908	Boehringer Mannheim Igm Assay	Boehringer Mannheim Corp.	1996	—
0 (this device)	K040431	Roche Diagnostics Tina-Quant Igm Gen.2	Roche Diagnostics Corp.	2004	—

FIG. 1 — Lineage of K040431, 1996–2004Source: 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 DAO? 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
*	K955908	Boehringer Mannheim Igm Assay Summary page 1 …stry analyzers. Predicate We claim substantial equivalence to the currently marketed Roche Device Diagnostics T'Ina-quant IgM assay. (K955908). 22 510(k) Summary - T…	Boehringer Mannheim Corp.	1996	—

Also cleared against K955908: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 17, 2018	Class II	Z-1147-2019	Device Design	New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K955908.

How does its category compare?

All DAO devices

DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DAO

FDA has decided no DAO device since 2007.

Median 510(k) review, days · DAO

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

Recalls per year · DAO

No recall names DAO since 2007.

Adverse event reports per year · DAO

4in 2025

2007high 4 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	2
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	1
2018	—	1
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	1
2024	—	3
2025	—	4
2026	—	—

What is it indicated for?

Immmumotibidimetric assay for the quaotitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers.

Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040431 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040431: Roche Diagnostics Tina-Quant Igm Gen.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040431

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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