510(k) · Cleared
ClearedActiclot Protein S, Model 843L
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 Sep 14, 2001 as substantially equivalent to K955738 (Medical Diagnostic Technologies, Inc., 1996) after a 49-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 14, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955738 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955738 Bioclot Protein SMedical Diagnostic Technologies, Inc. · 1996
- This deviceK012386 Acticlot Protein S, Model 843LAmerican Diagnostica, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955738 | Bioclot Protein S | Medical Diagnostic Technologies, Inc. | 1996 | — |
| 0 (this device) | K012386 | Acticlot Protein S, Model 843L | American Diagnostica, Inc. | 2001 | — |
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 |
|---|---|---|---|
| * | K955738 | Bioclot Protein SSummary page 1…Classification Name(s): 864.7290 Factor Deficiency Test, Class II 81GGP Test, Qualitative and Quantitative Factor Deficient Predicate Device: BIOCLOT Protein S-300 ACT K955738 Intended Use: ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activi… | 1996 |
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 GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the
quantitative determination of Protein S activity in human plasma.
Protein S activity levels in plasma are known to be low in patients with congenital
Protein S deficiencies type-I, type-Ila, and type-IIb, and may also be low in pregnant
women, in patients with liver disease and in inflammatory disease in which levels of C4b
binding protein are elevated. A decrease in Protein S activity is associated with an
increased incidence of thromboembolism.
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/K012386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012386: Acticlot Protein S, Model 843L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012386
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026