Prostate-specific Antigen (psa) For Management Of Prostate Cancers

Device Code: 3039

Product Code(s): LTJ

Device Classification Information

• Device Type ID: 3039
• Device Name: Prostate-specific Antigen (psa) For Management Of Prostate Cancers
• Regulation Description: Tumor-associated Antigen Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.6010 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LTJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3039
• Device: Prostate-specific Antigen (psa) For Management Of Prostate Cancers
• Product Code: LTJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Tumor-associated Antigen Immunological Test System.
• CFR Regulation Number: 866.6010 [🔎]

Premarket Reviews
Manufacturer	Decision
NANOENTEK INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Low Test Results	43
High Test Results	31
Mechanical Problem	11
Incorrect Or Inadequate Test Results	7
Adverse Event Without Identified Device Or Use Problem	4
Incorrect, Inadequate Or Imprecise Result Or Readings	3
Probe	2
Mixer	2
Incorrect Measurement	1
Seal	1
Device Subassembly	1
Brush	1
Human Factors Issue	1
Total Device Problems	108

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics, Inc	II	Sep-07-2016
2	Tosoh Bioscience Inc	II	Jun-05-2018

TPLC Last Update: 2019-04-02 20:22:57