Electrode, Ion Based, Enzymatic, Creatinine

Device Code: 300

Product Code(s): CGL

Device Classification Information

• Device Type ID: 300
• Device Name: Electrode, Ion Based, Enzymatic, Creatinine
• Regulation Description: Creatinine 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: 862.1225 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CGL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-203 CLSI GP42-A6 (Formerly H04-A6)
  Procedures And Devices For The Collection Of Diagnostic Capillary Blood Specimens; Approved Standard -- Sixth Edition

Total Product Life Cycle

• Device Type ID: 300
• Device: Electrode, Ion Based, Enzymatic, Creatinine
• Product Code: CGL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Creatinine Test System.
• CFR Regulation Number: 862.1225 [🔎]

Premarket Reviews
Manufacturer	Decision
NOVA
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	15
False Positive Result	5
Low Test Results	3
False Negative Result	1
Display	1
Display Or Visual Feedback Problem	1
Device Operational Issue	1
Device Component Or Accessory	1
Device Stops Intermittently	1
Screen	1
Electrical /Electronic Property Problem	1
High Test Results	1
Use Of Device Problem	1
Total Device Problems	33

Recalls
Manufacturer		Recall Class	Date Posted
1	Radiometer America Inc	II	Mar-18-2015

TPLC Last Update: 2019-04-02 19:32:24