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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 021 Date of Entry 03/18/2009 
FR Recognition Number 7-182
Standard
CLSI  M36-A
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
Scope/Abstract
This guideline provides the user with information about the biology of Toxoplasma gondii, the methods available for use in the laboratory diagnosis of human toxoplasmosis, techniques that should be performed for specific clinical situations, and how to interpret laboratory results.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.3780 Antigens, If, Toxoplasma Gondii Class 2 GLZ
§866.3780 Antigens, Iha, Toxoplasma Gondii Class 2 GMM
§866.3780 Antigens, Cf, Toxoplasma Gondii Class 2 GMN
§866.3780 Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Class 2 LGD
§866.3780 Antisera, If, Toxoplasma Gondii Class 2 LJK
§866.3780 Direct Agglutination Test, Toxoplasma Gondii Class 2 LLA
§866.3780 Pneumocystis Carinii Class 2 LYF
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Daisy Roy
  CDRH/OPEQ/OHTVII/DMD/VIR2
  --
  daisy.roy@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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