510(k) · Cleared
ClearedAstoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astoria-Pacific, Inc. · NAK System, Test, Biotinidase
Cleared on Sep 21, 2001 after a 184-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 21, 2001
- Review
- 184 days
- Class
- Class II
- Product code
- NAK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK010844 Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO.…Astoria-Pacific, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK090123 Neonatal Biotinidase Kit, Model 3018Perkinelmer, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK131284 GSP Neonatal Biotinidase KitWallac OY · 2013
- Descendant · cites it directly · 0 of its ownK080294 Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitAstoria-Pacific, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K090123Neonatal Biotinidase Kit, Model 3018Perkinelmer, Inc. · 2010 · cites it directly1descendant
- K131284GSP Neonatal Biotinidase KitWallac OY · 2013 · 2 generations on0descendants
- K080294Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitAstoria-Pacific, Inc. · 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) | K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K | Astoria-Pacific, Inc. | 2001 | — |
| +1 | K090123 | Neonatal Biotinidase Kit, Model 3018 | Perkinelmer, Inc. | 2010 | — |
| +2 | K131284 | GSP Neonatal Biotinidase Kit | Wallac OY | 2013 | — |
| +1 | K080294 | Astoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit | Astoria-Pacific, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NAK? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K090123 (Perkinelmer, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NAK devicesNAK System, Test, Biotinidase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · NAK
Too few NAK 510(k)s in any year since 2007 to give a median.
Recalls per year · NAK
No recall names NAK since 2007.
Adverse event reports per year · NAK
1in 2010
MAUDE reports naming product code NAK, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 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 | — |
https://510kreport.com/device/K010844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010844: Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010844
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026