510(k) · Cleared
ClearedK-Assay Apo AI
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 25, 1999 after a 20-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Oct 25, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- DER
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993345 K-Assay Apo AIKamiya Biomedical Co. · 1999
- Descendant · cites it directly · 0 of its ownK072977 Diazyme Apolipoprotein a-1 AssayGeneral Atomics · 2008
Most influential descendants
Showing 1 of 1 · See all- K072977Diazyme Apolipoprotein a-1 AssayGeneral Atomics · 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) | K993345 | K-Assay Apo AI | Kamiya Biomedical Co. | 1999 | — |
| +1 | K072977 | Diazyme Apolipoprotein a-1 Assay | General Atomics | 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 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 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K072977 | Diazyme Apolipoprotein a-1 Assay | 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, K072977 (General Atomics, 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 Al Assay is intended to be used for the quantitative determination of
Apo Al 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 diseases.
FOR IN VITRO DIAGNOSTIC USE.
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/K993345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993345: K-Assay Apo AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993345
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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