Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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2-304
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Standard | |
ASTM F2382-24 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
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Scope/Abstract1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4. See also Practice F2888. 1.2 All safety policies and practices shall be observed during the performance of this test method. 1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control (CDC) National Institutes of Health (NIH) Manual Biosafety in Microbiological and Biomedical Laboratories (BMBL, current edition). 1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the BSL-2 as recommended in the CDC/NIH Manual BMBL. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 9.8 phrase "(up to 5 min)". |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Section 9.8 phrase "(up to 5 min)" has a technical error ("up to 5 min" should be "up to 6 min") because it is inconsistent with Section 8.4 where it states "a read time of at least 300s".
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Transition Period
FDA recognition of ASTM F2382-18 [Rec# 2-266] will be superseded by recognition of ASTM F2382-24 [Rec# 2-304]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-266] until December 26, 2027. After this transition period, declarations of conformity to [Rec# 2-266] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.
2. ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |