510(k) · Cleared
ClearedDiazyme LP (a) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Atomics · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Jan 13, 2009 as substantially equivalent to K013359 (Denka Seiken'S, 2002) after a 138-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it.
- Decided
- Jan 13, 2009
- Review
- 138 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982708 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK982708 SPQ Test SystemDiaSorin, Inc. · 1999 · Recalled
- 1 generation backK013359 LP (a)-Latex Seiken Assay KitDenka Seiken'S · 2002
- This deviceK082488 Diazyme LP (a) AssayGeneral Atomics · 2009
- Descendant · cites it directly · 1 of its ownK122722 Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190…Roche Diagnostics · 2012
- Descendant · 2 generations on · 0 of its ownK241220 Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025
- Descendant · cites it directly · 0 of its ownK131556 Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013
Most influential descendants
Showing 3 of 3 · See all- K122722Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…Roche Diagnostics · 2012 · cites it directly1descendant
- K241220Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025 · 2 generations on0descendants
- K131556Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982708 | SPQ Test System | DiaSorin, Inc. | 1999 | 1 |
| −1 | K013359 | LP (a)-Latex Seiken Assay Kit | Denka Seiken'S | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K241220 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics Operations | 2025 | — |
| +1 | K131556 | Diazyme Lipoprotein (a) Calibrator Set, Control Set | Diazyme Laboratories | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K013359 | LP (a)-Latex Seiken Assay KitSummary page 2…Assay Substantial Equivalence Information 1. Predicate device name(s): Lp(a) Assay 2. Predicate 510(k) number(s): K013359 3. Comparison with predicate: Indications for Use Diazyme Lp(a) Assay Denka Lp(a) Assay… | 2002 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122722 (Roche Diagnostics, 2012) has gone furthest, with 1 descendant 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. 2009, 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 Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid-metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. Diazyme Lp(a)…
Read the full statement (98 words)
The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid-metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry.
Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082488: Diazyme LP (a) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082488
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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