Antinuclear Antibody (enzyme-labeled), Antigen, Controls

Device Code: 3030

Product Code(s): LJM

Device Classification Information

• Device Type ID: 3030
• Device Name: Antinuclear Antibody (enzyme-labeled), Antigen, Controls
• Regulation Description: Antinuclear Antibody 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: 866.5100 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LJM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-136 CLSI I/LA2-A2 (Replaces I/LA2-A)
  Quality Assurance Of Laboratory Tests For Autoantibodies To Nuclear Antigens: (1) Indirect Flurescence Assay For Microscopy And (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.

Total Product Life Cycle

• Device Type ID: 3030
• Device: Antinuclear Antibody (enzyme-labeled), Antigen, Controls
• Product Code: LJM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Antinuclear Antibody Immunological Test System.
• CFR Regulation Number: 866.5100 [🔎]

Premarket Reviews
Manufacturer	Decision
GOLD STANDARD DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
IMMCO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOVA DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHADIA AB
	SUBSTANTIALLY EQUIVALENT	2

TPLC Last Update: 2019-04-02 20:22:50