Clinical Sample Concentrator

Device Code: 455

Product Code(s): JJH

Device Type ID	455
Device Name	Clinical Sample Concentrator
Regulation Description	Clinical Sample Concentrator.
Regulation Medical Specialty	Clinical Chemistry
Review Panel	Clinical Chemistry
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(K) Exempt
CFR Regulation Number	862.2310 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	JJH
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	455
Device	Clinical Sample Concentrator
Product Code	JJH
FDA Device Classification	Class 1 Medical Device
Regulation Description	Clinical Sample Concentrator.
CFR Regulation Number	862.2310 [🔎]

Device Problems
Contamination During Use	6
Device Displays Incorrect Message	5
Leak / Splash	5
Device Contamination With Body Fluid	4
Device Operates Differently Than Expected	3
Circuit Failure	3
Incorrect, Inadequate Or Imprecise Result Or Readings	3
Incorrect Or Inadequate Test Results	3
Use Of Device Problem	2
Smoking	1
Human-Device Interface Problem	1
Missing Test Results	1
False Positive Result	1
Fire	1
Sparking	1
Device Ingredient Or Reagent Problem	1
Flare Or Flash	1
Charred	1
Fluid Leak	1
Overheating Of Device	1
Device Markings / Labelling Problem	1
Detachment Of Device Component	1
False Negative Result	1
Computer Operating System Problem	1
Pumping Problem	1
Device Handling Problem	1
Total Device Problems	51

TPLC Last Update: 2019-04-02 19:35:05