HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)

• K Number: K132722
• Device Name: HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
• Manufacturer: INSTRUMENTATION LABORATORY CO.
• Date Cleared: 2014-01-22 ( 145 days)
• Product Code: GJS , GIS
• Regulation Number: 864.7750
• Type: Special
• Panel: HE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Hemos!L RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibringgen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The text is an FDA 510(k) clearance letter for the HemosIL RecombiPlasTin 2G device, stating its substantial equivalence to a predicate device and outlining regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or ground truth establishment.

To answer your request, I would need a document that specifically details the performance evaluation of the HemosIL RecombiPlasTin 2G, including its acceptance criteria and the results of a study.

Regulation Number and Section

§ 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).