510(k) · Cleared
ClearedK-Assay Apo B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamiya Biomedical Co. · DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Cleared on Oct 28, 1999 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 28, 1999
- Review
- 23 days
- Class
- Class II
- Product code
- DER
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993354 K-Assay Apo BKamiya Biomedical Co. · 1999
- Descendant · cites it directly · 0 of its ownK073488 Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model…Diazyme Laboratories · 2008
Most influential descendants
Showing 1 of 1 · See all- K073488Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxDiazyme Laboratories · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993354 | K-Assay Apo B | Kamiya Biomedical Co. | 1999 | — |
| +1 | K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx | Diazyme Laboratories | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DER? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx | 2008 | 0 |
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?
- Of its descendants, K073488 (Diazyme Laboratories, 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DER devicesDER Alpha-1-Lipoprotein, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DER
FDA has decided no DER device since 2007.
Median 510(k) review, days · DER
Too few DER 510(k)s in any year since 2007 to give a median.
Recalls per year · DER
No recall names DER since 2007.
Adverse event reports per year · DER
2in 2024
MAUDE reports naming product code DER, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 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 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of Apo B in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal disorders. FOR IN VITRO DIAGNOSTIC USE.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993354: K-Assay Apo B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993354
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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