510(k) · Cleared
ClearedTina-Quant Igg Gen.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DEW Igg, Antigen, Antiserum, Control
Cleared on Feb 8, 2005 as substantially equivalent to K943997 (Behring Diagnostics, Inc., 1994) after a 21-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Feb 8, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- DEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943997 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943997 Behring Nephelometer IIBehring Diagnostics, Inc. · 1994
- This deviceK050113 Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
- Descendant · cites it directly · 3 of its ownK073490 Olympus Igg ReagentOlympus America, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK162208 DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK221114 Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020
Most influential descendants
Showing 4 of 4 · See all- K073490Olympus Igg ReagentOlympus America, Inc. · 2008 · cites it directly3descendants
- K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017 · 2 generations on1descendant
- K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · 3 generations on0descendants
- K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943997 | Behring Nephelometer II | Behring Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K050113 | Tina-Quant Igg Gen.2 | Roche Diagnostics Corp. | 2005 | — |
| +1 | K073490 | Olympus Igg Reagent | Olympus America, Inc. | 2008 | — |
| +2 | K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017 | — |
| +3 | K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023 | — |
| +2 | K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200… | Horiba Abx Sas | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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
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 |
|---|---|---|---|
| * | K943997 | Behring Nephelometer IISummary page 5…e claim equivalence to in Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) IgG assay on the BN I1 cleared under K943997. Both products are intended for use in the quantitative determination of IgG in human CSF. Substantial… | 1994 |
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 |
|---|---|---|---|
| K073490 | Olympus Igg Reagent | 2008 | 3 |
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, K073490 (Olympus America, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DEW devicesDEW 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEW
4in 2024
MAUDE reports naming product code DEW, 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 | 4 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 1 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.
Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
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/K050113 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050113: Tina-Quant Igg 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/K050113
Report an extraction error
Are you the manufacturer?
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