510(k) · Cleared
ClearedTina-quant Lipoprotein (a) Gen.2 Molarity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Operations · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Jan 24, 2025 as substantially equivalent to K122722 (Roche Diagnostics, 2012) after a 268-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jan 24, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K982708 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK982708 SPQ Test SystemDiaSorin, Inc. · 1999 · Recalled
- 3 generations backK013359 LP (a)-Latex Seiken Assay KitDenka Seiken'S · 2002
- 2 generations backK082488 Diazyme LP (a) AssayGeneral Atomics · 2009
- 1 generation backK122722 Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190…Roche Diagnostics · 2012
- This deviceK241220 Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982708 | SPQ Test System | DiaSorin, Inc. | 1999 | 1 |
| −3 | K013359 | LP (a)-Latex Seiken Assay Kit | Denka Seiken'S | 2002 | — |
| −2 | K082488 | Diazyme LP (a) Assay | General Atomics | 2009 | — |
| −1 | K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP… | Roche Diagnostics | 2012 | — |
| 0 (this device) | K241220 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics Operations | 2025 | — |
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
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 |
|---|---|---|---|
| * | K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…Summary page 5…nological test system. Product Codes, DFC, 21 CFR 866.5600 Regulation Numbers Predicate Device Tina-quant Lipoprotein (a) Gen.2 (K122722) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Registration Roche Diagnostics Gm… | 2012 |
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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2025, 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 Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.
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/K241220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241220: Tina-quant Lipoprotein (a) Gen.2 Molarity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241220
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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