(38 days)
N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem.
*not available in the U.S.
The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins:
fibrinogen antithrombin III prothrombin plasminogen alpha 1 - Antitrypsin C1 Inhibitor
Below is an analysis of the provided text regarding acceptance criteria and study details for the "N/T Protein Control PY" device. Please note that the document primarily focuses on demonstrating substantial equivalence and provides limited information typically found in a comprehensive medical device performance study, especially for AI-based devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a quality control material and focuses on its precision and stability, rather than diagnostic accuracy against a specific condition. Therefore, typical acceptance criteria like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria for this type of device generally revolve around its ability to provide consistent and stable control values.
| Acceptance Criteria Category | Specific Criteria/Metric | Target (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Precision | %CV (Coefficient of Variation) | Not explicitly stated as a target, but lower %CV is better indicating high precision. | Ranged from 1.11% to 2.72% for various parameters. |
| Stability (Lyophilized) | Duration of stability | Not explicitly stated as a target, but longer stability is better. | At least 12 months |
| Stability (Reconstituted) | Duration of stability | Not explicitly stated as a target, but longer stability is better. | 14 days |
Note: The document does not explicitly state numerical "acceptance criteria" for precision or stability (e.g., "%CV must be
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.