510(k) · Cleared
ClearedDiazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · MSJ Apolipoproteins
Cleared on Mar 7, 2008 as substantially equivalent to K993354 (Kamiya Biomedical Co., 1999) after a 137-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Mar 7, 2008
- Review
- 137 days
- Class
- Class I
- Product code
- MSJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993354 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993354 K-Assay Apo BKamiya Biomedical Co. · 1999
- This deviceK073488 Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model…Diazyme Laboratories · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993354 | K-Assay Apo B | Kamiya Biomedical Co. | 1999 | — |
| 0 (this device) | K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx | Diazyme Laboratories | 2008 | — |
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 MSJ? 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 |
|---|---|---|---|
| * | K993354 | K-Assay Apo BSummary page 2…lipoprotein Immunological Test System Lipoprotein test system, we are claiming equivalence [807.92(a) (3) to K-ASSAY APO B ASSAY (k993354) manufactured by Kamiya Biomedical Company 18… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MSJ devicesMSJ Apolipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MSJ
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MSJ
Too few MSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MSJ
No recall names MSJ since 2007.
Adverse event reports per year · MSJ
No MAUDE report names MSJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.
For calibration of the Diazyme Apolipoprotein B Assay in serum. For in vitro Diagnostic Use.
To monitor the performance of Diazyme Apolipoprotein B Assay in serum. For in vitro Diagnostic Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073488 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073488: Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073488
Report an extraction error
Are you the manufacturer?
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