Product Classification

• Device: calibrator, multi-analyte mixture
• Regulation Description: Calibrator.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JIX
• Submission Type: 510(k)
• Regulation Number: 862.1150
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• NCCLS C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
• NCCLS C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (2000) ISBN1-56238-398-1

Guidance Document

• Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final  

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

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