Electrode, Ion Specific, Calcium

Device Code: 387

Product Code(s): JFP

Device Classification Information

• Device Type ID: 387
• Device Name: Electrode, Ion Specific, Calcium
• Regulation Description: Calcium Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1145 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JFP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized 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

Total Product Life Cycle

• Device Type ID: 387
• Device: Electrode, Ion Specific, Calcium
• Product Code: JFP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Calcium Test System.
• CFR Regulation Number: 862.1145 [🔎]

Premarket Reviews
Manufacturer	Decision
MEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
High Test Results	4
Low Test Results	3
Incorrect Or Inadequate Test Results	1
Total Device Problems	8

TPLC Last Update: 2019-04-02 19:33:51