510(k) · Cleared
Recalled · Class II · 2018Tina-Quant Albumin Gen 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · DCF Albumin, Antigen, Antiserum, Control
Cleared on Sep 10, 2010 as substantially equivalent to K932950 (Boehringer Mannheim Corp., 1995) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 10, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- DCF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895883 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK895883 Beckman MA Microalbumin Reagent KitBeckman Instruments, Inc. · 1989
- 1 generation backK972929 N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
- This deviceK101203 Tina-Quant Albumin Gen 2Roche Diagnostics · 2010
- Descendant · cites it directly · 0 of its ownK113072 Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012
Most influential descendants
Showing 1 of 1 · See all- K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895883 | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | 1989 | — |
| −1 | K972929 | N Antiserum to Human Albumin | Behring Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K101203 | Tina-Quant Albumin Gen 2 | Roche Diagnostics | 2010 | — |
| +1 | K113072 | Tina-Quant Albumin Gen.2 | Roche Diagnostics Operations | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 DCF? 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? (2)
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 |
|---|---|---|---|
| * | K932950 | Tina-Quant MicroalbuminSummary page 2…tantially equivalence equivalent to the Hitachi Microalbumnin urine assay. The Hitachi Microalbumin urine assay was cleared under K932950. The Serum/plasma and CSF applications of the Tina-quant Albumin Gen. 2 assa… | 1995 |
| * | K972929 | N Antiserum to Human AlbuminSummary page 2…s of the Tina-quant Albumin Gen. 2 assays are substantially equivalent to the Behring Nephelometric method cleared in K972929. Substantial equivalence - comparison Feature Tina-quant Albumin Gen. 2 Assay… | 1997 |
| † | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113072 | Tina-Quant Albumin Gen.2 | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2018 | Class II | Z-1124-2019 | Device Design | COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113072 (Roche Diagnostics Operations, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DCF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DCF
167in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCF
12in 2025
MAUDE reports naming product code DCF, 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 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 167 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101203 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101203: Tina-Quant Albumin Gen 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101203
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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