(23 days)
HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
This 510(k) submission (K070301) for HemosIL Antithrombin is a re-submission to modify the "Expected Values" section of the product insert. It explicitly states that the device itself is not materially different from the previously FDA-cleared predicate device (K980499 HemosIL Antithrombin).
Therefore, this document does not contain a new study demonstrating the device meets acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device, whose previous clearance would have involved studies meeting acceptance criteria. The information provided is primarily focused on the regulatory process for a labeling change, rather than a new performance study.
Given this, I cannot provide a detailed answer to your request in the format you specified, as the document does not contain the required information about a new performance study.
However, I can extract the following information that is present in the provided text:
- Device Name: HemosIL Antithrombin
- Intended Use: Quantitative determination of Antithrombin in human plasma to monitor heparin administration in thrombosis treatment and as an aid in diagnosing thrombophilia (congenital Antithrombin deficiency).
- Regulatory Information:
- Regulation Number: 21 CFR 864.7060
- Regulation Name: Antithrombin III Assay
- Product Code: JBQ
- Regulatory Class: Class II
- Predicate Device: K980499 HemosIL Antithrombin
- Reason for Submission: Modification of the "Expected Values" section in the product insert to reference published literature and emphasize the need for each laboratory to establish its own normal range.
- Statement on Technological Characteristics: "HemosIL Antithrombin with the modified Expected Values section in the product insert is not materially different from the FDA cleared device."
- Expected Values (Modified Section): "Antithrombin activity levels in healthy individuals are approximately in the range of 83 - 128%. Antithrombin levels are low in neonates/infants and increase to adult levels by approximately 1 year of age; levels are then slightly higher than in adults up to age 16 year. Due to many variables which may affect results, each laboratory should establish its own normal range." This section references: Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336.
To answer your request, one would need to access the original 510(k) submission for the predicate device (K980499 HemosIL Antithrombin), as that is where the performance data and acceptance criteria would have been established and demonstrated. This current document does not provide any of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set size, etc.) because it is not a submission for a new device or significant modification requiring new performance data.
§ 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).