510(k) · Cleared

Cleared

Roche Diagnostics Tina-Quant Igg Gen.2

K040434510(k) SpecialCleared Mar 10, 200420-day reviewClass II21 CFR 866.5510

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

Roche Diagnostics Corp. · DEW Igg, Antigen, Antiserum, Control

Cleared on Mar 10, 2004 as substantially equivalent to K955906 (Boehringer Mannheim Corp., 1996) after a 20-day review. Its family tree reaches back 1 generation to 1996.

Decided: Mar 10, 2004
Review: 20 days
Class: Class II
Product code: DEW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955906 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK955906 Boehringer Mannheim Igg AssayBoehringer Mannheim Corp. · 1996
This deviceK040434 Roche Diagnostics Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955906	Boehringer Mannheim Igg Assay	Boehringer Mannheim Corp.	1996	—
0 (this device)	K040434	Roche Diagnostics Tina-Quant Igg Gen.2	Roche Diagnostics Corp.	2004	—

FIG. 1 — Lineage of K040434, 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 DEW? 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
*	K955906	Boehringer Mannheim Igg Assay Summary page 1 …istry analyzers. Predicate We claim substantial equivalence to the currently marketed Roche Device Diagnostics Tina-quant IgG assay. (K955906). 22 510(k) Summary -…	Boehringer Mannheim Corp.	1996	—

Also cleared against K955906: 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)

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.
1 other device also cites its predicate K955906.

How does its category compare?

All DEW devices

DEW Igg, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEW

FDA has decided no DEW device since 2007.

Median 510(k) review, days · DEW

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

Recalls per year · DEW

1in 2024

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DEW

4in 2024

2007high 19 (2020) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	4
2010	—	1	2
2011	—	0	16
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	2
2016	—	0	4
2017	—	0	6
2018	—	0	1
2019	—	0	9
2020	—	0	19
2021	—	0	0
2022	—	0	0
2023	—	0	1
2024	—	1	4
2025	—	0	0
2026	—	0	—

What is it indicated for?

Immunoturbidimetric assay for the quantitative in vitro determination of IgG 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/K040434 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040434: Roche Diagnostics Tina-Quant Igg Gen.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040434

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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