510(k) · Cleared
ClearedAstoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit
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 Nov 4, 2008 as substantially equivalent to K010844 (Astoria-Pacific, Inc., 2001) after a 274-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 4, 2008
- Review
- 274 days
- Class
- Class II
- Product code
- NAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010844 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010844 Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO.…Astoria-Pacific, Inc. · 2001
- This deviceK080294 Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitAstoria-Pacific, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K | Astoria-Pacific, Inc. | 2001 | — |
| 0 (this device) | K080294 | Astoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit | Astoria-Pacific, Inc. | 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 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? (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 |
|---|---|---|---|
| * | K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13KSummary page 2…evice for which substantial equivalence is claimed Product Classification Regulation Number 21 CFR 862.1118 5 10(k) Number K010844 Classification Panel Clinical Chemistry Product Code NAK Device Classification C… | 2001 |
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.
- 1 other device also cites its predicate K010844.
How does its category compare?
All NAK devicesNAK System, Test, Biotinidase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
This method is for the semi-quantitative determination of biotinidase, EC 3.5.1.12, activity in dried whole blood spots using a spectrophotometer. Measurement of biotinidase activity is primarily for the diagnosis and treatment of biotinidase deficiency in newborns. This method is intended for in vitro diagnostic use in screening for decreased levels of biotinidase activity and not for monitoring purposes.
This device is for use by trained, qualified clinical laboratory personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080294: Astoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080294
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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