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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 7-220
CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
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.
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.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.7320 Fibrin Split Products Class 2 GHH
§864.7320 Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class 2 DAP
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.
FDA Technical Contacts
 Takeesha Taylor-Bell
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/HB/
  240-402-6566
  Takeesha.Taylor-Bell@fda.hhs.gov
 Lea Carrington
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/
  301-796-6164
  lea.carrington@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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