510(k) · Cleared
Recalled · Class II · 2012Spectrolyse Pai-1, Model 101201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Diagnostica, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Aug 15, 2007 as substantially equivalent to K922782 (Biopool AB, 1992) after a 285-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 2 times.
- Decided
- Aug 15, 2007
- Review
- 285 days
- Class
- Class II
- Product code
- GGP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922782 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK922782 Spectrolyse/PL Pai KitBiopool AB · 1992
- This deviceK063323 Spectrolyse Pai-1, Model 101201American Diagnostica, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922782 | Spectrolyse/PL Pai Kit | Biopool AB | 1992 | — |
| 0 (this device) | K063323 | Spectrolyse Pai-1, Model 101201 | American Diagnostica, Inc. | 2007 | — |
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 GGP? 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 GGP device
- #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K922782 | Spectrolyse/PL Pai KitSummary page 1…Name(s): 864.7290 Test, Qualitative And Quantitative Factor Deficiency GGP Hematology Reagents, Class II Predicate Device: SpectrolyselpL PAI K922782 Description of the Device Spectrolyse ® PAI-I is a two stage colorimetric assay. The first stage involves incubating samples wit… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2012 | Class II | Z-0463-2013 | Nonconforming Material/Component | Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions. |
| Aug 28, 2012 | Class II | Z-2431-2012 | Process control | SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions. |
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 GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GGP
153in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGP
3in 2025
MAUDE reports naming product code GGP, 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 | 3 | 153 | 2 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Spectrolyse®PAI-1 kit, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-I (PAI-I) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063323: Spectrolyse Pai-1, Model 101201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063323
Report an extraction error
Are you the manufacturer?
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