510(k) · Cleared
ClearedAct Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JBP Activated Whole Blood Clotting Time
Cleared on Jan 14, 2000 as substantially equivalent to K832189 (International Technidyne Corp., 1983) and 2 other predicates after a 143-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jan 14, 2000
- Review
- 143 days
- Class
- Class II
- Product code
- JBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K832189 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832189 Hemochron ThrombochronometerInternational Technidyne Corp. · 1983
- This deviceK992851 Act Test Catridges for Coaguchek Pro System, Act Controls for…Roche Diagnostics Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832189 | Hemochron Thrombochronometer | International Technidyne Corp. | 1983 | — |
| 0 (this device) | K992851 | Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro… | Roche Diagnostics Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
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 JBP? 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 JBP device
- #1 K223635 Sonoclot Coagulation & Platelet Function…score 4.6 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K832189 | Hemochron ThrombochronometerSummary page 1…3) Predicate We claim substantial equivalence to the International Technidyne Corporation device ACT Test and controls for the Hemochron Whole Blood Coagulation System, K832189, K913861, K960749. Continued on next page Roche Diagnostics 25 August 23, 1999 510(k) Summary, Continued 4) Dev… | 1983 |
| * | K913861 | Hemochron (R) KactSummary page 1…cate We claim substantial equivalence to the International Technidyne Corporation device ACT Test and controls for the Hemochron Whole Blood Coagulation System, K832189, K913861, K960749. Continued on next page Roche Diagnostics 25 August 23, 1999 510(k) Summary, Continued 4) Device Descr… | 1991 |
| * | K960749 | Hemochron JR. Microcoagulation Low Range ActSummary page 1…laim substantial equivalence to the International Technidyne Corporation device ACT Test and controls for the Hemochron Whole Blood Coagulation System, K832189, K913861, K960749. Continued on next page Roche Diagnostics 25 August 23, 1999 510(k) Summary, Continued 4) Device Description 5… | 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?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All JBP devicesJBP Activated Whole Blood Clotting Time: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JBP
Too few JBP 510(k)s in any year since 2007 to give a median.
Recalls per year · JBP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JBP
18in 2025
MAUDE reports naming product code JBP, 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 | 1 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 3 | 29 |
| 2010 | 0 | — | 3 | 24 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CoaguChek Pro ACT test cartridge is for the quantitative determination of the
activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is
intended for health care professional use only.
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/K992851 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992851: Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992851
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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