510(k) · Cleared
Recalled · Class I · 2014Inratio Self-Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemosense, Inc. · GJS Test, Time, Prothrombin
Cleared on Oct 24, 2002 after a 135-day review. The FDA summary names its predicate without a number. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- Oct 24, 2002
- Review
- 135 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 4 (2 Class I)
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK021923 Inratio Self-TestHemosense, Inc. · 2002
- 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
- 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
- K110212 INRATIO2 PI/NR Monitoring System; Inratio PT/Inr…cites it directly · 2012
Most influential descendants
Showing 4 of 4 · 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
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K021923 | Inratio Self-Test | Hemosense, Inc. | 2002 | — |
| +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 | — |
| +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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 1 |
| 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.
2 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 |
|---|---|---|---|
| * | — | The INRatio System Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
| Oct 11, 2011 | Not classified | Z-0188-2012 | Material/Component Contamination | Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus. |
| Sep 7, 2005 | Not classified | Z-0132-06 | Other | A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. |
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.
- 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?
- 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?
The HemoSense INRatio is an in vitro diagnostic system that provides a quantitative prothrombin time results, expressed in seconds and as an International Normalized Ratio (INR). It uses fresh capillary whole blood and is intended for is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021923: Inratio Self-Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021923
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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