510(k) · Cleared
ClearedApo-Tek LP (a)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimmune, Inc. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Nov 10, 1997 as substantially equivalent to K910552 (Roche Diagnostic Systems, Inc., 1991) and 1 other predicate after a 287-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Nov 10, 1997
- Review
- 287 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870564 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870564 SPQ (TM) Test System for Apolipoprotein BAtlantic Antibodies · 1987
- This deviceK970302 Apo-Tek LP (a)Perimmune, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870564 | SPQ (TM) Test System for Apolipoprotein B | Atlantic Antibodies | 1987 | — |
| 0 (this device) | K970302 | Apo-Tek LP (a) | Perimmune, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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? (2)
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 |
|---|---|---|---|
| * | K910552 | Roche Reagent for Apolipoprotein BSummary page 1…Lp(a)™ is similar in design and function to the Roche Reagent for Apolipoprotein B manufactured by Roche Diagnostics, which was the subject of a Premarket Notification #K910552, and the SPQ™ Test System for Apolipoprotein B manufactured by Atlantic Antibodies, which was the subject of Premarket Notificati… | 1991 |
| * | K870564 | SPQ (TM) Test System for Apolipoprotein BSummary page 1…of a Premarket Notification #K910552, and the SPQ™ Test System for Apolipoprotein B manufactured by Atlantic Antibodies, which was the subject of Premarket Notification #K870564 1330 Piccard Drive » Rockville, MD 20850-4396 » Tel. (301) 258-5200 » Fax (301) 840-2161 4, Summary Apo-Tek Lp(… | 1987 |
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?
- None of the 2 ancestors has a recall.
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?
Apo-Tek Lp(a)™ is an Apo(a) isoform independent enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma. The measurement of Lp(a), in conjunction with other lipoprotein tests, is of diagnostic significance when assessing atherosclerotic cardiovascular disease in specific 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/K970302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970302: Apo-Tek LP (a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970302
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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