510(k) · Cleared
ClearedDiazyme Lipoprotein (a) Calibrator Set, Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · JIT Calibrator, Secondary
Cleared on Jun 26, 2013 as substantially equivalent to K082488 (General Atomics, 2009) after a 28-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jun 26, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982708 (1999). No later device cites it as a predicate yet.
- 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 deviceK131556 Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013
View FIG. 1 as a table
Line of descent and top descendants
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 JIT? 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? (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 |
|---|---|---|---|
| * | K082488 | Diazyme LP (a) AssaySummary page 2…sification Panel: Clinical Chemistry (75) ‘Product Code: JIT, JJX Submission Type Special 510k Legally marketed device to which equivalency is claimed: K082488, Diazyme Lp(a) calibrators and controls Manufactu‘ring Address Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 Establis… | 2009 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K082488.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Diazyme Lipoprotein (a) Calibrator Set is intended for use in establishing the calibration curve for the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
The Diazyme Lipoprotein (a) Control Set is intended for use in monitoring the quality control of results obtained with the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
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/K131556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131556: Diazyme Lipoprotein (a) Calibrator Set, Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131556
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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