510(k) · Decided
Recalled · Class I · 2016INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere San Diego, Inc (Formally Biosite Incorporate · GJS Test, Time, Prothrombin
Cleared on May 1, 2012 as substantially equivalent to K020679 (Hemosense, Inc., 2002) and 3 other predicates after a 462-day review. Its family tree reaches back 3 generations to 2002. 5 of the 5 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including 5 Class I recalls.
- Decided
- May 1, 2012
- Review
- 462 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 5 (5 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K020679 (2002). 4 ancestors in all. No later device cites it as a predicate yet. 5 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK020679 InratioHemosense, Inc. · 2002 · Recalled (Class I)
- 2 generations backK072727 Inratio 2 PT Monitoring SystemHemosense, Inc. · 2007 · Recalled (Class I)
- 1 generation backK092987 Inratio/INRATIO2 Test StripsBiosite Incorporated · 2010 · Recalled (Class I)
- This deviceK110212 INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020679 | Inratio | Hemosense, Inc. | 2002 | Class I |
| −2 | K072727 | Inratio 2 PT Monitoring System | Hemosense, Inc. | 2007 | Class I |
| −1 | K092987 | Inratio/INRATIO2 Test Strips | Biosite Incorporated | 2010 | Class I |
| 0 (this device) | K110212 | INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip | Alere San Diego, Inc (Formally Biosite Incorporate | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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.
5 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? (4)
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 |
|---|---|---|---|
| * | K020679 | InratioSummary page 1…re lNRatio®2 PT/INR Home Monitoring System Alere lNRatio®D2 PT/INR Test Strip C. Predicate Devices: lNRatio® PT Monitoring System, K020679 lNRatio® PT Monitoring System, K02 1923 lNRatio®-2 PT/INR Monitoring… | 2002 |
| * | K021923 | Inratio Self-TestSummary page 1…Alere lNRatio®D2 PT/INR Test Strip C. Predicate Devices: lNRatio® PT Monitoring System, K020679 lNRatio® PT Monitoring System, K02 1923 lNRatio®-2 PT/INR Monitoring System, K072727 lNRatio® PT/INR Test Str… | 2002 |
| * | K072727 | Inratio 2 PT Monitoring SystemSummary page 1…o® PT Monitoring System, K020679 lNRatio® PT Monitoring System, K02 1923 lNRatio®-2 PT/INR Monitoring System, K072727 lNRatio® PT/INR Test Strip, K092987 D. Device Description: The INRatio2 PT/INR Monitoring… | 2007 |
| * | K092987 | Inratio/INRATIO2 Test StripsSummary page 1…atio® PT Monitoring System, K02 1923 lNRatio®-2 PT/INR Monitoring System, K072727 lNRatio® PT/INR Test Strip, K092987 D. Device Description: The INRatio2 PT/INR Monitoring Systems (Professional and Home) perform a modified version o… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2016 | Class I | Z-2359-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with… |
| Jul 11, 2016 | Class I | Z-2358-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with… |
| Jul 11, 2016 | Class I | Z-2354-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with… |
| 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… |
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.
- K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 2010 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
- K072727Inratio 2 PT Monitoring SystemHemosense, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K021923Inratio Self-TestHemosense, Inc. · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K020679InratioHemosense, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 4 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K020679.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Alere INRatio®2 PT/INR Monitoring System (Professional Use): The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clonting time by health care professionals. The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is…
Read the full statement (251 words)
Alere INRatio®2 PT/INR Monitoring System (Professional Use): The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clonting time by health care professionals. The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.
Limitations: The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
Alere INRatio®2 PT/INR Home Monitoring System: The Alere INRatio®2 PT/INR Home Monitoring System, consisting of the INRatio®2 Home Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The The Alere INRatio®2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Home Monitoring System is not intended to be used, for screening purposes.
Limitations: The Alere INRatio®2 PT/INR Home Monitoring System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
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/K110212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110212: INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110212
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