510(k) · Cleared
ClearedAstoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astoria-Pacific, Inc. · JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Cleared on May 11, 1999 as substantially equivalent to K790211 (Sigma Chemical Co., 1979) after a 50-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- May 11, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- JBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K790211 (1979). No later device cites it as a predicate yet.
- Root · 1 generation backK790211 Dehydrogenose, Glucose PhosphateSigma Chemical Co. · 1979
- This deviceK990957 Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KAstoria-Pacific, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790211 | Dehydrogenose, Glucose Phosphate | Sigma Chemical Co. | 1979 | — |
| 0 (this device) | K990957 | Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K | Astoria-Pacific, Inc. | 1999 | — |
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 JBL? 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 |
|---|---|---|---|
| * | K790211 | Dehydrogenose, Glucose PhosphateSummary page 2…the legally marketed device for which substantial equivalence is claimed. Product Classification Product Code 81 JBL Regulation Number 21 CFR 864.7360 510(k) Number K790211 S/E Decision Date March 15, 1979 Classification Panel Hematology Kits and Packages Device Classification Class Il Product Nome… | 1979 |
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.
How does its category compare?
All JBL devicesJBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBL
FDA has decided no JBL device since 2007.
Median 510(k) review, days · JBL
Too few JBL 510(k)s in any year since 2007 to give a median.
Recalls per year · JBL
No recall names JBL since 2007.
Adverse event reports per year · JBL
No MAUDE report names JBL since 2007.
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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is intended for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes using the Astoria-Pacific SPOTCHECK Analyzer. Measurements of glucose-6-phosphate dehydrogenase activity are used primarily in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a G6PD deficiency. It is for in vitro diagnostic use primarily as an aid in screening for decreased levels of G6PD enzyme activity. This device is for use by trained, qualified laboratory personnel.
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/K990957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990957: Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990957
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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