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510(k) Data Aggregation
(462 days)
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 clotting 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 INRation2 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.
The INRatio2 PT/INR Monitoring Systems (Professional and Home) perform a modified version of the one-stage Prothrombin Time test, using commercially available recombinant human thromboplastin (rhTP) reagent. The clot formed in the Prothrombin Time (PT) reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor heats the test strip to the proper reaction temperature; a measure clot impedance and provides a result on a screen (user interface). The clotting reaction occurs on the Test Strip after the blood sample is applied. An International Normalized Ratio (INR) value is calculated from measured Prothrombin Time and the INR is displayed on the monitor to the user/patient.
The Alere INRatio2 PT/INR Monitoring System and INRatio2 PT/INR Test Strips were evaluated for performance against acceptance criteria. The study aimed to demonstrate equivalent or better performance compared to previously cleared devices.
Here's a breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table (pages 3-6) showing the performance of the new INRatio2 PT/INR Monitoring System utilizing the modified Alere™ INRatio2 PT/INR Test Strip against the previous INRatio/INRatio2 Monitoring PT/INR Test Systems.
| Parameter | Acceptance Criteria (Previous INRatio/INRatio2 Systems) | Reported Device Performance (INRatio2 PT/INR System with modified strip) | Comment/Explanation of Difference |
|---|---|---|---|
| Intended Use | Quantitative measurement of PT in fresh capillary whole blood for professional and home use to monitor warfarin therapy. Not for screening. | Same, but with added specificity for "International Normalized Ratio (INR)" and "monitoring the effect of warfarin on clotting time by health care professionals" (Professional Use) and "by properly selected suitably trained users (by prescription for home use or other order of a treating physician)" (Home Use). Patients must be stabilized (>6 weeks) for Home Use. | Addition of patient self-testing to the intended use of the INRatio2 PT/INR Monitoring System (for Home Use). Clarification of limitations for both professional and home use regarding patients transitioning from heparin treatment to warfarin therapy. |
| Intended Users | Healthcare professionals and trained patients. | Same | No change. |
| Intended Sample | Capillary whole blood | Capillary whole blood | No change. |
| Test Strip Monitor Compatibility | INRatio (professional and patient self test) and INRatio2 (professional) monitors | INRatio2 (professional and patient self-test) | Addition of patient self-testing to the intended use of Alere INRatio2 PT/INR Monitoring System. The new strip is specifically designed for the INRatio2 monitors. |
| Mode of Measurement | Electrical Impedance | Same | No change. |
| Number of Reaction Sites | 3 (3 Pairs of Electrodes) | Same | No change. |
| Test Strip Layout | "Trident" | Same | No change. |
| Quality Control | Integrated in Test Strip | Same | No change. |
| Test Strip Graphics | Name of product | Name of product and thumbprint and directional leading arrow | Thumbprint and directional leading arrow graphic added to test strip for ease of use. |
| Minimum Sample Volume | 15 µL | 9.5 µL | Miniaturized micro-fluidic design of Test Strip channels allows for reduction in minimum sample volume and increases ease of use. |
| Test Time | Approximately 1 min for INRatio2 | Approximately 1 min for INRatio2 | No change. |
| Measurement Range (INR) | 0.7 - 7.5 | 0.7 - 7.5 | No change. |
| Measurement Range (PT) | 7 - 75 sec | Not reported | PT seconds units are no longer reported in package insert; INR units are now industry standard. |
| Reference Range (INR) | 0.7 - 1.2 | 0.8 - 1.3 | Reflects verified normal reference range. PT range is no longer reported in package insert; INR units are now industry standard. |
| Reference Range (PT) | 6.5 - 11.9 sec | Not reported | PT seconds units are no longer reported in package insert; INR units are now industry standard. |
| Strip Calibration | Per WHO889:1999, using normal and therapeutic capillary whole blood samples vs. reference method using normal and therapeutic venous whole blood samples processed to plasma | Same | No change. |
| Accuracy | Slope = 0.9 – 1.1, Intercept ± 0.5 INR | Slope = 0.9 – 1.1, Intercept ± 0.5 INR | No change. |
| Precision (Repeatability) - Normal subjects Capillary %CV | 7.6% | 8.2% | Minor change; reflects current performance of the test strip. This is likely still within acceptable analytical variation. |
| Precision (Repeatability) - Therapeutic Capillary %CV | 5.9% | 6.2% | Minor change; reflects current performance of the test strip. This is likely still within acceptable analytical variation. |
| Between Day Precision - Normal Subjects %CV | 8.5% | Not Applicable (Therapeutic Patient Self Testers Capillary %CV - 5.7%) | No longer reported on package insert as this number is not clinically useful; Between Day Precision can only be determined for normal subjects who are not the intended test population; This is now industry standard. The reported value (5.7%) for Therapeutic Patient Self Testers suggests good between-day precision in the relevant population. |
| Endogenous Interfering Factors: | |||
| - Bilirubin | None up to 20 mg/dL | None up to 30 mg/dL | Reflects current performance of the test strip, indicating improved resistance to bilirubin interference. |
| - Hemoglobin/Hemolysis | None up to 500 mg/dL | None up to 1000 mg/dL | Reflects current performance of the test strip, indicating improved resistance to hemoglobin interference. |
| - Lipemia/triglycerides | None up to 1500 mg/dL | None up to 1500 mg/dL | No change. |
| Factor Sensitivity: | |||
| - Factor II | <49% of normal factor level | <56% of normal factor level | Reflects current performance of the test strip. The slightly higher percentage suggests a minor change in sensitivity, which needs to be clinically acceptable. |
| - Factor VII | <74% of normal factor level | <78% of normal factor level | Reflects current performance of the test strip. The slightly higher percentage suggests a minor change in sensitivity, which needs to be clinically acceptable. |
| - Factor X | <72% of normal factor level | <74% of normal factor level | Reflects current performance of the test strip. The slightly higher percentage suggests a minor change in sensitivity, which needs to be clinically acceptable. |
| Exogenous Interfering Factors: | |||
| - Fondaparinux | Not previously characterized | Up to 5 mg/L | Further characterization of potential interfering factors; reflects values to appear in labeling. This is an improvement in known interference profiles. |
| - Acetylsalicylic acid | Not previously characterized | Up to 4 mmol/L | Further characterization of potential interfering factors; reflects values to appear in labeling. This is an improvement in known interference profiles. |
| - Clopidogrel | Not previously characterized | Up to 20 mg/dL | Further characterization of potential interfering factors; reflects values to appear in labeling. This is an improvement in known interference profiles. |
| - Atovastatin | Not previously characterized | Up to 600 µg/L | Further characterization of potential interfering factors; reflects values to appear in labeling. This is an improvement in known interference profiles. |
| - Unfractionated Heparin | Not previously characterized | ≥ 2 IU/mL | Further characterization of potential interfering factors; reflects values to appear in labeling. This is an improvement in known interference profiles. |
| - Low molecular weight Heparin | Not previously characterized | ≥ 3 IU/mL | Further characterization of potential interfering factors; reflects values to appear in labeling. This is an improvement in known interference profiles. |
| Hematocrit range | 30 - 55% | 25 - 53% | Expanded range on low end to include a larger patient population; decreased range on upper end. Accuracy was established up to 55% HCT. This allows use in a broader patient population. |
| Operating conditions: Temperature | 10 - 35°C (50 - 95°F) | 10 - 32°C (50 - 90°F) | Reflects current performance of the system (monitor and strip). The narrower upper temperature limit indicates less temperature tolerance than the previous system, but is likely still within acceptable limits for typical use environments. |
| Operating conditions: Humidity | 10%-95% RH | 15%-90% RH | Reflects current performance of the system (monitor and strip). The narrower humidity range indicates less humidity tolerance than the previous system, but is likely still within acceptable limits for typical use environments. |
| Strip warm-up time (Refrig storage) | 5 min at RT, if stored refrig | Same | No change. |
| Strip warm-up time (RT storage) | N/A, if stored at RT | Same | No change. |
| Strip Stability (Out of pouch) | 10 minutes | Same | No change. |
| Strip Stability (Pouched) | 15 months at recommended storage conditions | 11 months at recommended storage conditions | Shelf Life at room temperature based on currently available real time stability data. This indicates a shorter shelf life for the new strips. |
Study Proving Acceptance Criteria:
The document states that "Clinical testing validated that the INRatio2 PT/INR Monitoring Systems (Professional and Home) utilizing the INRatio2 PT/INR Test Strips, when used by trained patient users or healthcare professionals, performed with acceptable accuracy compared to the reference method (the Sysmex CA-560 Anticoagulation Analyzer) per ISO 17593:2007." (Section G. Clinical Data).
Furthermore, "Performance testing verified that the modified INRatio2 PT/INR Test Strips have equivalent or better performance compared to the previously cleared INRatio PT/INR Test Strips with respect to precision, accuracy, and potential interferents when used with the INRatio2 PT/INR Monitoring Systems (Professional or Home). The performance claims currently in the labeling have been changed to reflect the performance of the INRatio2 PT/INR Test Strips." (Nonclinical Data section).
Missing Information (Not explicitly stated in the provided text):
While the document states clinical and performance testing was done, several specific details requested in the prompt are not explicitly provided in the text:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the clinical or performance testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, "Clinical testing validated" implies prospective collection for that specific validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The ground truth is established by a reference method (Sysmex CA-560 Anticoagulation Analyzer), not by human experts.
4. Adjudication method for the test set:
- Not applicable as the ground truth is an objective measurement from a reference analyzer.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an in-vitro diagnostic device for measuring INR, not an imaging device requiring human reader interpretation or AI assistance in that context. The "users" are healthcare professionals or trained patients operating the device. The comparison is between the device's output and a reference method.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device inherently operates as an algorithm-only system to generate INR values from the applied blood sample. Its "standalone" performance is assessed by comparing its output directly to the reference standard, as implied by the accuracy statements. The "human-in-the-loop" refers to applying the sample and reading the result, but not interpreting raw data from the device itself.
7. The type of ground truth used:
- Reference Method: Sysmex CA-560 Anticoagulation Analyzer. This is a recognized laboratory instrument for coagulation testing, providing objective, quantitative data.
8. The sample size for the training set:
- Not explicitly stated. The document focuses on validation/performance testing, not on the specific "training" that would be typical for machine learning models. For a device like this, the "training" would be the development and calibration of the assay, likely involving a different set of samples than the final performance validation.
9. How the ground truth for the training set was established:
- Not explicitly stated. Similar to point 8, the ground truth for internal development and calibration would typically be established using a gold standard laboratory method. The document mentions "Strip Calibration per WHO889:1999, using normal and therapeutic capillary whole blood samples vs. reference method using normal and therapeutic venous whole blood samples processed to plasma," which describes the general method for calibrating the strips.
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