Kappa, Antigen, Antiserum, Control

Device Code: 2970

Product Code(s): DFH

Device Classification Information

• Device Type ID: 2970
• Device Name: Kappa, Antigen, Antiserum, Control
• Regulation Description: Immunoglobulin (light Chain Specific) Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.5550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DFH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-113 CLSI I/LA23-A (Replaces I/LA23-P)
  Assessing The Quality Of Immunoassay Systems: Radioimmunoassays, And Enzyme, Fluorescence, And Luminescence Immunoassays; Approved Guideline

Total Product Life Cycle

• Device Type ID: 2970
• Device: Kappa, Antigen, Antiserum, Control
• Product Code: DFH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunoglobulin (light Chain Specific) Immunological Test System.
• CFR Regulation Number: 866.5550 [🔎]

Premarket Reviews
Manufacturer	Decision
DIAZYME LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	2
THE BINDING SITE GROUP LTD
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:21:55