510(k) · Cleared
Recalled · 2007Acticlot, Model 824
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Diagnostica, Inc. · GJS Test, Time, Prothrombin
Cleared on Oct 17, 2005 as substantially equivalent to K940490 (American Diagnostica, Inc., 1995) after a 73-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Oct 17, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940490 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK940490 DV Test and DVV ConfirmAmerican Diagnostica, Inc. · 1995
- This deviceK052124 Acticlot, Model 824American Diagnostica, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940490 | DV Test and DVV Confirm | American Diagnostica, Inc. | 1995 | — |
| 0 (this device) | K052124 | Acticlot, Model 824 | American Diagnostica, Inc. | 2005 | — |
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 GJS? 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 GJS device
- #1 K243543 microINR Systemscore 13.4 · 6 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 |
|---|---|---|---|
| * | K940490 | DV Test and DVV ConfirmSummary page 2…n Name: Russell Viper Venom Reagent Device Classification: Class I Regulation Number: Title 21 CFR § 864.8950 Panel: Hematology Reagents Product Code: GIR K Number: K940490 Description of the Device: ACTICLOTR dPT'M is a test kit. It has three reagents that are used selectively for a screening proto… | 1995 |
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 |
|---|---|---|---|---|
| Feb 28, 2007 | Not classified | Z-0779-2007 | Other | Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas |
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 GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GJS
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJS
1in 2022
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GJS
105in 2025
MAUDE reports naming product code GJS, 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 | 4 | 77 | 5 | 439 |
| 2008 | 1 | — | 3 | 420 |
| 2009 | 0 | — | 4 | 876 |
| 2010 | 4 | 168 | 2 | 2,177 |
| 2011 | 0 | — | 1 | 2,965 |
| 2012 | 1 | — | 1 | 2,198 |
| 2013 | 1 | — | 1 | 2,584 |
| 2014 | 1 | — | 4 (3) | 2,397 |
| 2015 | 0 | — | 0 | 1,260 |
| 2016 | 1 | — | 0 | 864 |
| 2017 | 1 | — | 5 | 532 |
| 2018 | 2 | — | 3 (2) | 1,958 |
| 2019 | 2 | — | 0 | 2,385 |
| 2020 | 1 | — | 2 | 1,390 |
| 2021 | 0 | — | 1 | 1,359 |
| 2022 | 3 | 399 | 1 | 1,210 |
| 2023 | 2 | — | 0 | 809 |
| 2024 | 1 | — | 0 | 177 |
| 2025 | 3 | 60 | 0 | 105 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACTICLOT® dPT is intended for the qualitative determination of Lupus Anticoagulants (LA) in human plasma. The test is for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052124: Acticlot, Model 824.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052124
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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