510(k) · Cleared
Recalled · 2005SPQ Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Apr 2, 1999 after a 241-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 2, 1999
- Review
- 241 days
- Class
- Class II
- Product code
- DFC
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK982708 SPQ Test SystemDiaSorin, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK013359 LP (a)-Latex Seiken Assay KitDenka Seiken'S · 2002
- Descendant · 2 generations on · 3 of its ownK082488 Diazyme LP (a) AssayGeneral Atomics · 2009
- Descendant · 2 generations on · 1 of its ownK122722 Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190…Roche Diagnostics · 2012
- Descendant · 3 generations on · 0 of its ownK241220 Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025
- Descendant · 3 generations on · 0 of its ownK131556 Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013
Most influential descendants
Showing 5 of 5 · See all- K013359LP (a)-Latex Seiken Assay KitDenka Seiken'S · 2002 · cites it directly4descendants
- K082488Diazyme LP (a) AssayGeneral Atomics · 2009 · 2 generations on3descendants
- K122722Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…Roche Diagnostics · 2012 · 2 generations on1descendant
- K241220Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025 · 3 generations on0descendants
- K131556Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982708 | SPQ Test System | DiaSorin, Inc. | 1999 | — |
| +1 | K013359 | LP (a)-Latex Seiken Assay Kit | Denka Seiken'S | 2002 | — |
| +2 | K082488 | Diazyme LP (a) Assay | General Atomics | 2009 | — |
| +2 | K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP… | Roche Diagnostics | 2012 | — |
| +3 | K241220 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics Operations | 2025 | — |
| +3 | K131556 | Diazyme Lipoprotein (a) Calibrator Set, Control Set | Diazyme Laboratories | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Strategic Diagnostics Macra Lp (a) Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013359 | LP (a)-Latex Seiken Assay Kit | 2002 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2005 | Not classified | Z-0636-05 | Other | QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013359 (Denka Seiken'S, 2002) has gone furthest, with 4 descendants of its own.
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.
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 SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(@) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurment of Lp(a) is Indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations.
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/K982708 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982708: SPQ Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982708
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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