510(k) · Cleared
Recalled · Class I · 2016Inratio/INRATIO2 Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · GJS Test, Time, Prothrombin
Cleared on Jun 11, 2010 as substantially equivalent to K072727 (Hemosense, Inc., 2007) after a 256-day review. Its family tree reaches back 2 generations to 2002. 4 of the 4 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 7 times, including 6 Class I recalls.
- Decided
- Jun 11, 2010
- Review
- 256 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 7 (6 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020679 (2002). 1 later device descends from it, 1 citing it directly. 4 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK020679 InratioHemosense, Inc. · 2002 · Recalled (Class I)
- 1 generation backK072727 Inratio 2 PT Monitoring SystemHemosense, Inc. · 2007 · Recalled (Class I)
- This deviceK092987 Inratio/INRATIO2 Test StripsBiosite Incorporated · 2010
- Descendant · cites it directly · 0 of its ownK110212 INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K110212INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020679 | Inratio | Hemosense, Inc. | 2002 | Class I |
| −1 | K072727 | Inratio 2 PT Monitoring System | Hemosense, Inc. | 2007 | Class I |
| 0 (this device) | K092987 | Inratio/INRATIO2 Test Strips | Biosite Incorporated | 2010 | — |
| +1 | K110212 | INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip | Alere San Diego, Inc (Formally Biosite Incorporate | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
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 |
|---|---|---|---|
| * | K072727 | Inratio 2 PT Monitoring SystemSummary page 1…othrombin Time Test Common/usual name Prothrombin Time Test Proprietary name INRatio Test Strips C. Predicate Device: lNRatio2 System, K072727 D. Device Description: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110212 | INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip Class I | 2012 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2016 | Class I | Z-2362-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2… |
| Jul 11, 2016 | Class I | Z-2361-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR… |
| Dec 5, 2014 | Class I | Z-0881-2015 | Under Investigation by firm | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical… |
| Dec 5, 2014 | Class I | Z-0880-2015 | Under Investigation by firm | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical… |
| Dec 5, 2014 | Class I | Z-0882-2015 | Under Investigation by firm | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical… |
| Apr 16, 2014 | Class I | Z-1546-2014 | Under Investigation by firm | Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when… |
| Feb 28, 2011 | Not classified | Z-2661-2011 | Other | The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections. |
The 5 latest of 7 recalls; the web page lists all.
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.
- K072727Inratio 2 PT Monitoring SystemHemosense, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K020679InratioHemosense, Inc. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K110212INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K110212 (Alere San Diego, Inc (Formally Biosite Incorporate, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072727.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio/INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio/INRatio 2 PT Monitoring system is not intended to be used for screening purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092987: Inratio/INRATIO2 Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092987
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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