| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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7-220
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| Standard | |
CLSI H59-A (Replaces H59-P)
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
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Scope/Abstract| This document provides guidelines regarding the use of D-dimer in exclusion of venous thromboembolism (VTE) including a description of the value of clinical determination of the pretest probability of VTE; the proper collection and handling of the specimen; assays used for D-dimer analysis; determination of the threshold for exclusion of VTE; interpretation of test results; and aspects of regulatory and accreditation requirements. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 9.4 Methods That a Laboratory May Use to Determine the Threshold for Exclusion of Venous Thromboembolism.
Appendix - Table A1 Example of the Level of Supporting Evidence Used to Discriminate Between "Aid in Diagnosis of VTE" vs "Exclusion of VTE" Product "Indications for Use" Claims.
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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.
Section 9.4 is in conflict with a test method and/or specification that is not scientifically acceptable, see article listed below. FDA does not recognize section 9.4 Methods that a laboratory may use to determine a threshold for exclusion of venous thromboembolism, because it is intended for clinical laboratory validation and not intended for a manufacturer [or submitter, etc.] to meet a premarket requirement for these devices under the FD&C Act.
Table A1 is in conflict with an existing published final guidance, see section 6 Statistically Inappropriate Practices in the guidance listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §864.7320 |
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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Class 2
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DAP
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| §864.7320 |
Fibrin Split Products
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Class 2
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GHH
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Relevant FDA Guidance and/or Supportive Publications*
Zucker, M.L (2011). D-dimer for the Exclusion of Venous Thromboembolism. Laboratory Medicine, 42 (8), p. 503-504.
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Reviewers, Issued March 2007.
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. |
