(30 days)
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.
Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor. disposable test strips, instruction manual, quick reference guide, training video/DVD, and testing supplies. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The Test Strips have not been modified from the design described in K020679.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving device performance:
Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with performance metrics. The document is a 510(k) summary for the INRatio® 2 PT Monitoring System, primarily focusing on its substantial equivalence to a predicate device. It defines the device, its intended use, and presents the FDA's clearance letter.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information. The document explicitly states that the INRatio 2 PT Monitoring System is a "hardware and software modification of the INRatio System" and that "The INRatio 2 and the INRatio have the same intended use and use the same operating principle." This suggests that the substantial equivalence claim relies heavily on the prior clearance of the original INRatio System (K020679) and that extensive new clinical studies to establish new performance criteria were likely not performed as part of this 510(k) submission.
To illustrate what a full answer would look like if the information were present, I'll provide a template with placeholders and explanations for each requested section.
Acceptance Criteria and Device Performance Study Analysis (Based on Hypothetical Data)
As the provided 510(k) summary for the INRatio® 2 PT Monitoring System (K072727) does not explicitly detail acceptance criteria or a specific study proving it meets them beyond a claim of substantial equivalence to its predicate, the following information is presented as a template for what would be expected in such a description. If a detailed study was included, it was not part of the publicly available summary provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Accuracy (vs. Lab Reference Method) | Mean difference between INRatio 2 PT and central lab PT = 0.98 compared to reference at various PT levels | R-squared: 0.995 |
| User Agreement (for point-of-care) | >= 95% of user-performed tests produce valid results | 98% |
| Inter-device agreement | Difference between devices |
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).