510(k) · Cleared
Recalled · 2005Coaguchek PT.S Test for Prothrombin Time Self-Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · GJS Test, Time, Prothrombin
Cleared on May 22, 2003 as substantially equivalent to K962571 (Boehringer Mannheim Corp., 1997) after a 66-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- May 22, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962571 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK962571 Coaguchek PST SystemBoehringer Mannheim Corp. · 1997 · Recalled
- This deviceK030845 Coaguchek PT.S Test for Prothrombin Time Self-TestingRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 2 of its ownK093243 Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK183255 Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK212779 Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient…Coagusense, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · cites it directly2descendants
- K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · 2 generations on1descendant
- K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962571 | Coaguchek PST System | Boehringer Mannheim Corp. | 1997 | 4 |
| 0 (this device) | K030845 | Coaguchek PT.S Test for Prothrombin Time Self-Testing | Roche Diagnostics Corp. | 2003 | — |
| +1 | K093243 | Coagusense Self-Test Prothrombin Time/Inr Monitoring System | Coagusense, Inc. | 2010 | 1 |
| +2 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019 | 1 |
| +3 | K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K962571 | Coaguchek PST SystemSummary page 1…ing. Most notably, the system is substantially equivalent to the currently marketed CoaguChek System for Prothrombin Time Self-Testing (K96257 1). Continued on next page… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093243 | Coagusense Self-Test Prothrombin Time/Inr Monitoring System | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2005 | Not classified | Z-0098-06 | Other | Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K093243 (Coagusense, Inc., 2010) has gone furthest, with 2 descendants of its own.
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?
For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030845: Coaguchek PT.S Test for Prothrombin Time Self-Testing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030845
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