510(k) · Cleared
Recalled · Class II · 2020Coaguchek XS 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 Aug 11, 2006 as substantially equivalent to K020831 (Roche Diagnostics Corp., 2002) after a 123-day review. Its family tree reaches back 2 generations to 2001. 4 of the 19 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 11, 2006
- Review
- 123 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010599 (2001). 16 later devices descend from it, 5 citing it directly. 4 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 1 generation backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- This deviceK060978 Coaguchek XS SystemRoche Diagnostics · 2006
- Descendant · cites it directly · 6 of its ownK071041 Coaguchek XS Plus SystemRoche Diagnostics · 2007 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK180780 microINR SystemIline Microsystems, S.L. · 2019
- Descendant · 2 generations on · 3 of its ownK201185 microINR SystemIline Microsystems, S.L. · 2020
- Descendant · 3 generations on · 2 of its ownK231711 microINR SystemIline Microsystems, S.L. · 2023
- Descendant · 2 generations on · 1 of its ownK243543 microINR SystemIline Microsystems, S.L. · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K071041Coaguchek XS Plus SystemRoche Diagnostics · 2007 · cites it directly6descendants
- K180780microINR SystemIline Microsystems, S.L. · 2019 · cites it directly4descendants
- K201185microINR SystemIline Microsystems, S.L. · 2020 · 2 generations on3descendants
- K231711microINR SystemIline Microsystems, S.L. · 2023 · 3 generations on2descendants
- K243543microINR SystemIline Microsystems, S.L. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −1 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | — |
| +1 | K071041 | Coaguchek XS Plus System | Roche Diagnostics | 2007 | Class I |
| +1 | K180780 | microINR System | Iline Microsystems, S.L. | 2019 | — |
| +2 | K201185 | microINR System | Iline Microsystems, S.L. | 2020 | — |
| +3 | K231711 | microINR System | Iline Microsystems, S.L. | 2023 | — |
| +2 | K243543 | microINR System | Iline Microsystems, S.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2010 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2018 | 2 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
4 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 |
|---|---|---|---|
| * | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404Summary page 1…ercial distribution intended for similar use. Most notably, it is substantially equivalent to the Roche Diagnostics CoaguChek S System (K02083 1). 4) Device The CoaguChek XS is a 3 a generation CoaguChek meter which measures Description prothrombin time in fre… | 2002 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2020 | Class II | Z-0803-2021 | Device Design | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| May 16, 2013 | Class II | Z-1584-2013 | 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-2002-2009 | 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.
- K071041Coaguchek XS Plus SystemRoche Diagnostics · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K170960CoaguChek Vantus SystemRoche Diagnostics · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K180684CoaguChek XS Plus SystemRoche Diagnostics · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K093460Coaguchek XS Pro SystemRoche Diagnostics · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K071041 (Roche Diagnostics, 2007) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K020831.
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 CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or non-anticoagulated venous whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060978: Coaguchek XS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060978
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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