Recognized Consensus Standards

Recognition List Number: 013 Publication Date: 10/31/2005 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-113: CLSI I/LA23-A, Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guidelines. (InVitro Diagnostics)

Date of Standard: 2004. 

Address of Standards 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)
	DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)

(2)	OFFICE OF COMPLIANCE (OC)

Devices Affected:

Immunoglobulins A, G, M, D, and E, immunological test system devices using radioimmunoassay methods or enzyme, fluorescence, or luminescence immunoassay methods

Processes Affected:

510(k), PMA, PDP, IDE

Type of Standard:

 National, Horizontal

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§866.5510	Iga, Antigen, Antiserum, Control	Class 2	CZP
§866.5510	Iga, Peroxidase, Antigen, Antiserum, Control	Class 2	CZL
§866.5510	Igd, Antigen, Antiserum, Control	Class 2	CZJ
§866.5510	Igd, Peroxidase, Antigen, Antiserum, Control	Class 2	DGH
§866.5510	Ige, Peroxidase, Antigen, Antiserum, Control	Class 2	DGO
§866.5510	Igg (Gamma Chain Specific), Antigen, Antiserum, Control	Class 2	DFZ
§866.5510	Igg, Antigen, Antiserum, Control	Class 2	DEW
§866.5510	Igg, Peroxidase, Antigen, Antiserum, Control	Class 2	DAA
§866.5510	Radioimmunoassay, Immunoglobulins (D, E)	Class 2	JHR
§866.5510	Radioimmunoassay, Immunoglobulins (G, A, M)	Class 2	CFQ
Regulation Number	Device Name	Device Class	Product Code
§866.5520	Fab, Antigen, Antiserum, Control	Class 1	DCE
§866.5520	Igg (Fab Fragment Specific), Antigen, Antiserum, Control	Class 1	DFK
Regulation Number	Device Name	Device Class	Product Code
§866.5530	Fc, Antigen, Antiserum, Control	Class 1	DBN
§866.5530	Igg (Fc Fragment Specific), Antigen, Antiserum, Control	Class 1	DAS
§866.5530	Reagent, Immunoassay, Igg	Class 1	KTO
Regulation Number	Device Name	Device Class	Product Code
§866.5540	Igg (Fd Fragment Specific), Antigen, Antiserum, Control	Class 1	DAQ
Regulation Number	Device Name	Device Class	Product Code
§866.5550	Igm (Mu Chain Specific), Antigen, Antiserum, Control	Class 2	DAO
§866.5550	Igm, Antigen, Antiserum, Control	Class 2	DFT
§866.5550	Igm, Peroxidase, Antigen, Antiserum, Control	Class 2	DEY
§866.5550	Kappa, Antigen, Antiserum, Control	Class 2	DFH
§866.5550	Kappa, Peroxidase, Antigen, Antiserum, Control	Class 2	DFD
§866.5550	Lambda, Antigen, Antiserum, Control	Class 2	DEH
§866.5550	Lambda, Peroxidase, Antigen, Antiserum, Control	Class 2	DEP

FDA Technical Contact:

  James Reeves

  FDA/CDRH/OIVD

  2098 GAITHER ROAD, HFZ-440

  ROCKVILLE MD 20850

  240/276-1290

  Email: james.reeves@fda.hhs.gov