510(k) · Cleared
Recalled · Class I · 2018Coaguchek XS Plus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · GJS Test, Time, Prothrombin
Cleared on May 11, 2007 as substantially equivalent to K060978 (Roche Diagnostics, 2006) after a 29-day review. Its family tree reaches back 3 generations to 2001. 3 of the 10 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- May 11, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010599 (2001). 6 later devices descend from it, 4 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 2 generations backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- 1 generation backK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- This deviceK071041 Coaguchek XS Plus SystemRoche Diagnostics · 2007
- Descendant · cites it directly · 1 of its ownK180684 CoaguChek XS Plus SystemRoche Diagnostics · 2018 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK093460 Coaguchek XS Pro SystemRoche Diagnostics · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK253188 CoaguChek XS Plus SystemRoche Diagnostics · 2025
- Descendant · cites it directly · 0 of its ownK220282 i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories · 2023
- Descendant · 2 generations on · 0 of its ownK180693 CoaguChek XS Pro SystemRoche Diagnostics · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K180684CoaguChek XS Plus SystemRoche Diagnostics · 2018 · cites it directly1descendant
- K093460Coaguchek XS Pro SystemRoche Diagnostics · 2010 · cites it directly1descendant
- K253188CoaguChek XS Plus SystemRoche Diagnostics · 2025 · 2 generations on0descendants
- K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories · 2023 · cites it directly0descendants
- K180693CoaguChek XS Pro SystemRoche Diagnostics · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −2 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| −1 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| 0 (this device) | K071041 | Coaguchek XS Plus System | Roche Diagnostics | 2007 | — |
| +1 | K180684 | CoaguChek XS Plus System | Roche Diagnostics | 2018 | Class I |
| +1 | K093460 | Coaguchek XS Pro System | Roche Diagnostics | 2010 | Class I |
| +2 | K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025 | — |
| +1 | K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | 2023 | — |
| +2 | K180693 | CoaguChek XS Pro System | Roche Diagnostics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 1 |
| 2018 | 2 | 1 |
| 2023 | 1 | 0 |
| 2025 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K060978 | Coaguchek XS SystemSummary page 1…e blood. Predicate The Roche Diagnostics CoaguChek XS Plus System is substantially Device equivalent to to the previously cleared CoaguChek XS System (K060978). Similarities The table below indicates the similarities between the CoaguChek XS Plus System and the Coa… | 2006 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2018 | Class I | Z-0360-2019 | Nonconforming Material/Component | Abnormally high INR test results with the affected CoaguChek test strips |
| May 16, 2013 | Class II | Z-1583-2013 | Software design | Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. |
| Jul 22, 2009 | Not classified | Z-2004-2009 | Device Design | The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K180684 (Roche Diagnostics, 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K060978.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071041: Coaguchek XS Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071041
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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