510(k) · Cleared
ClearedCobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2 Califrator Set Model 05852641160
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Nov 29, 2012 as substantially equivalent to K013359 (Denka Seiken'S, 2002) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Nov 29, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982708 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK982708 SPQ Test SystemDiaSorin, Inc. · 1999 · Recalled
- 2 generations backK013359 LP (a)-Latex Seiken Assay KitDenka Seiken'S · 2002
- 1 generation backK082488 Diazyme LP (a) AssayGeneral Atomics · 2009
- This deviceK122722 Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190…Roche Diagnostics · 2012
- Descendant · cites it directly · 0 of its ownK241220 Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025
Most influential descendants
Showing 1 of 1 · See all- K241220Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982708 | SPQ Test System | DiaSorin, Inc. | 1999 | 1 |
| −2 | K013359 | LP (a)-Latex Seiken Assay Kit | Denka Seiken'S | 2002 | — |
| −1 | K082488 | Diazyme LP (a) Assay | General Atomics | 2009 | — |
| 0 (this device) | K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP… | Roche Diagnostics | 2012 | — |
| +1 | K241220 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics Operations | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DFC? 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 DFC device
- #1 K253069 Lipoprotein (a) Molarity Assayscore 11.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K013359 | LP (a)-Latex Seiken Assay KitSummary page 5…Assay Comparison of assays - Lp(a)-Latex Seiken assay TQ Lp(a) Gen.2 assay similarities Feature (predicate device: k013359) (candidate device) and The Lp(a)-Latex Seiken Assay The cobas c Tina-… | 2002 |
| * | K082488 | Diazyme LP (a) AssaySummary page 4…, Ltd. (kO 13359). (2) Preciset Lp(a) Gen.2 calibrator set is equivalent to the Diazyme Lp(a) calibrator set, General Atomics (k082488). (3) Preciontrol Lp(a) Gen.2 control set is equivalent to the Diazyme Lp(a) control s… | 2009 |
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 |
|---|---|---|---|
| K241220 | Tina-quant Lipoprotein (a) Gen.2 Molarity | 2025 | 0 |
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K241220 (Roche Diagnostics Operations, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013359.
How does its category compare?
All DFC devicesDFC Lipoprotein, Low-Density, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DFC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFC
Too few DFC 510(k)s in any year since 2007 to give a median.
Recalls per year · DFC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFC
7in 2025
MAUDE reports naming product code DFC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 2 | 16 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. The Preciset…
Read the full statement (118 words)
The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The Preciontrol Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122722: Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2 Califrator Set Model 05852641160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122722
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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