Product Classification

• Device: igg (fab fragment specific), antigen, antiserum, control
• Regulation Description: Immunoglobulin G (Fab fragment specific) immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: DFK
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(K) Exempt
• Regulation Number: 866.5520
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 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

Third Party Review

Not Third Party Eligible