Product Classification

• Device: electrode, ion specific, calcium
• Regulation Description: Calcium test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JFP
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1145
• 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 Standards

• 7-87 CLSI C31-A2 (Replaces C31-A)
  Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
• 7-89 CLSI C39-A (Replaces C39-P)
  A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc