510(k) · Cleared
Recalled · Class II · 2019Roche Diagnostics Tina-Quant Iga Gen.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CZP Iga, Antigen, Antiserum, Control
Cleared on Mar 10, 2004 as substantially equivalent to K955907 (Boehringer Mannheim Corp., 1996) after a 20-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 10, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- CZP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955907 (1996). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK955907 Boehringer Mannheim Iga AssayBoehringer Mannheim Corp. · 1996
- This deviceK040435 Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 3 of its ownK103824 Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012
- Descendant · 2 generations on · 1 of its ownK191985 Optilite IgA KitThe Binding Site Group, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK192116 Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012 · cites it directly3descendants
- K191985Optilite IgA KitThe Binding Site Group, Ltd. · 2019 · 2 generations on1descendant
- K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · 3 generations on0descendants
- K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955907 | Boehringer Mannheim Iga Assay | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K040435 | Roche Diagnostics Tina-Quant Iga Gen.2 | Roche Diagnostics Corp. | 2004 | — |
| +1 | K103824 | Human Iga Liquid Reagent Kit for Use on Spa Plus | The Binding Site | 2012 | — |
| +2 | K191985 | Optilite IgA Kit | The Binding Site Group, Ltd. | 2019 | — |
| +3 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group, Ltd. | 2025 | 1 |
| +2 | K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 1 | 0 |
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 CZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CZP device
- #1 K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200…score 0.2 · 3 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K955907 | Boehringer Mannheim Iga AssaySummary page 1…stry analyzers. Predicate We claim subs~tantial equivalence to the currently marketed Roche Device Diagnostics Tina-quant IgA assay. (K95 5907). 22 510(k) Summary -… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103824 | Human Iga Liquid Reagent Kit for Use on Spa Plus | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2019 | Class II | Z-1979-2019 | Material/Component Contamination | Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CZP devicesCZP Iga, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CZP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CZP
Too few CZP 510(k)s in any year since 2007 to give a median.
Recalls per year · CZP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CZP
1in 2025
MAUDE reports naming product code CZP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immanoturbidimetric assay for the quantitative in vitro determination of IgA 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/K040435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040435: Roche Diagnostics Tina-Quant Iga 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/K040435
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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