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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 7-206: CLSI I/LA20-A2, analytical performance characteristics and clinical utility of immunological assays for human immunoglobulin e (ige) antibodies and defined allergen specificities; approved guideline - second edition. (InVitro Diagnostics)

Date of Standard: 2009. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Immunological Assays for Human Immunoglobuline E (IGE) Antibodies of Defined Allergen Specificity
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§878.4480 Powder, Dusting, Surgical Class 3 KGP
§866.5510 Ige, Antigen, Antiserum, Control Class 2 DGC
§866.5510 Radioimmunoassay, Immunoglobulins (D, E) Class 2 JHR
§866.5750 System, Test, Radioallergosorbent (Rast) Immunological Class 2 DHB
Relevant Guidance:
The Decision Summaries of recently cleared Allergy IVD devices in FDA database may be considered for use.

Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact:
 Sic Chan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5627
  Silver Spring MD 20993
  301/796-7015
  email: sic.chan@fda.hhs.gov
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