(146 days)
ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
ChromoCheck™ Antithrombin is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer
ChromoCheck™ Antithrombin Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria for the ChromoCheck™ Antithrombin device. Instead, it demonstrates substantial equivalence to a predicate device (Coamatic Antithrombin) through a correlation study. The performance of ChromoCheck™ Antithrombin is assessed by its correlation with this predicate device.
| Parameter | Acceptance Criteria | Reported Device Performance (ChromoCheck™ Antithrombin) |
|---|---|---|
| Correlation | (Inferred: Strong correlation with predicate device, typically R² > 0.95 and slope close to 1) | Lot 1: Y-intercept = 1.389, Slope = 0.988, R² = 0.992 |
| Lot 2: Y-intercept = -2.095, Slope = 1.036, R² = 0.989 |
Conclusion: The reported R² values of 0.992 and 0.989, and slopes close to 1 (0.988 and 1.036) indicate a very strong linear correlation with the predicate device, suggesting the device meets an implicit acceptance criterion of high concordance with an established method.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 50 normal and pathological patient samples.
- Data Provenance: Not explicitly stated, but given the submitter's location (Dartmouth, Nova Scotia, Canada), it is likely to be from Canada or a mix of sources. The study is retrospective as it compares with an existing predicate.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The ground truth for this study is the measurement obtained from the predicate device, Coamatic Antithrombin, not expert consensus.
4. Adjudication Method for Test Set
Not applicable. The study involves direct comparison of quantitative measurements from two devices, not expert adjudication of subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/human-in-the-loop study. It is a comparison of two quantitative in-vitro diagnostic assays.
6. Standalone Performance Study
Yes, a standalone performance study was done for the ChromoCheck™ Antithrombin in the sense that its measurements were recorded independently. However, its effectiveness was determined by comparison to a predicate, rather than against an 'absolute' ground truth. The study demonstrates the device's ability to produce quantitative antithrombin activity results.
7. Type of Ground Truth Used
The "ground truth" for this study was the quantitative antithrombin activity results obtained from the predicate device, Coamatic® Antithrombin.
8. Sample Size for Training Set
Not applicable. This device is an in vitro diagnostic assay, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).