(305 days)
microINR System:
The microlNR System (consisting of the microINR Chip) is intended for multiple-patient use by professional healthcare providers for the determination of International Normalized Ratio (INR) to monitor Oral Anticoagulation Therapy (OAT) warfarin. The microINR System uses fresh capillary whole blood. The microNR System is intended for in vitro diagnostic use at the point-of-care.
The microlNR System is intended for use in patients 18 years of age and older. Patients must be stabilized (≥ 6 weeks) on warfarin.
Caution: The microINR System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. The microINR System is not intended to be used for screening purposes.
The microINR chips are only intended to be used with the microINR meter.
microINR Control Level A / microINR Control Level B:
The microlNR Control is intended for quality control performed on the microINR Meter when used with the disposable microINR Chips.
iLine Microsystems has available two microNR Control Levels (A and B) to perform quality control checks in the therapeutic range on the microINR System.
The microINR Control is intended for professional use only.
The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action.
The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection.
The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.
In addition to the microINR® On-Board Controls, the microINR® Control has been developed as an optional liquid quality control solution. The microINR® Control must be used only by healthcare professionals in order to meet the regulatory compliance requirements applicable to the facility where they are to be used.
The microINR® Control contains lyophilized human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) modified by means of a dedicated process to simulate an abnormal coagulation sample and a calcium chloride solution. Before use, the lyophilized plasma must be reconstituted with the calcium chloride solution.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for accuracy in a tabulated format that is distinct from the reported performance. The "Performance Characteristics" section outlines various analytical performance aspects, and the "Method comparison with Laboratory Reference device" section provides data related to accuracy. We can infer the performance metrics from this section.
| Performance Characteristic | Acceptance Criteria (Inferred from context and predicate comparison) | Reported Device Performance (microINR® System) |
|---|---|---|
| Accuracy (Method Comparison with Laboratory Reference Device): | A strong correlation to the reference method (e.g., Pearson (r) close to 1) and acceptable slope/intercept. | N: 260 |
| Slope: 1.04 | ||
| Intercept: 0.02 | ||
| Pearson (r): 0.978 | ||
| **Repeatability (INR |
§ 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).