Product Classification

• Device: hepatitis a test (antibody and igm antibody)
• Regulation Description: Hepatitis A virus (HAV) serological assays.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LOL
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3310
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-197 CLSI M35-A2 (Replaces M35-A)
  Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.

Guidance Documents

• Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents; Hepatitis A Virus Serological Assays; Availability.

• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays

Third Party Review

Not Third Party Eligible