Product Classification

• Device: enzyme controls (assayed and unassayed)
• Regulation Description: Quality control material (assayed and unassayed).
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JJT
• Submission Type: 510(k)
• Regulation Number: 862.1660
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI C24-A3 Statistical Quality Control for Quantitative Measurements Procedures: Principles and Definitions; Approved Guideline - Third Edition

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.