Azo Dye, Calcium

Device Code: 366

Product Code(s): CJY

Device Classification Information

• Device Type ID: 366
• Device Name: Azo Dye, 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: CJY
• 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: 366
• Device: Azo Dye, Calcium
• Product Code: CJY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Calcium Test System.
• CFR Regulation Number: 862.1145 [🔎]

Premarket Reviews
Manufacturer	Decision
ELITECHGROUP
	SUBSTANTIALLY EQUIVALENT	1
RANDOX LABORATORIES LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Low Test Results	46
High Test Results	34
Mechanical Problem	25
Adverse Event Without Identified Device Or Use Problem	19
Packaging Problem	4
Probe	3
Tube	3
Diaphragm	3
Nozzle	3
Washer	2
Pump	2
Incorrect Or Inadequate Test Results	2
Cooling Module	1
Device Subassembly	1
Cell	1
Valve	1
High Readings	1
Appropriate Term/Code Not Available	1
Total Device Problems	152

Recalls
Manufacturer		Recall Class	Date Posted
1	Ortho-Clinical Diagnostics	II	Jul-23-2016
2	Randox Laboratories Ltd.	II	Feb-15-2019
3	Vital Diagnostics, Inc.	II	Jan-14-2014

TPLC Last Update: 2019-04-02 19:33:31