Hepatitis A Test (antibody And Igm Antibody)

Device Code: 3431

Product Code(s): LOL

Device Classification Information

• Device Type ID: 3431
• Device Name: Hepatitis A Test (antibody And Igm Antibody)
• Regulation Description: Hepatitis A Virus (HAV) Serological Assays.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3310 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LOL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-197 CLSI M35-A2 (Replaces M35-A)
  Abbreviated Identification Of Bacteria And Yeast; Approved Guideline - Second Edition.

Total Product Life Cycle

• Device Type ID: 3431
• Device: Hepatitis A Test (antibody And Igm Antibody)
• Product Code: LOL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hepatitis A Virus (HAV) Serological Assays.
• CFR Regulation Number: 866.3310 [🔎]

Premarket Reviews
Manufacturer	Decision
DIASORIN
	SUBSTANTIALLY EQUIVALENT	2
DIASORIN S.P.A
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
High Test Results	47
False Positive Result	37
Adverse Event Without Identified Device Or Use Problem	19
Incorrect Or Inadequate Test Results	9
Low Test Results	7
Mechanical Problem	4
Computer Software Problem	1
False Negative Result	1
Non Reproducible Results	1
High Readings	1
Total Device Problems	127

Recalls
Manufacturer		Recall Class	Date Posted
1	Roche Diagnostics Corporation	II	Jan-29-2019

TPLC Last Update: 2019-04-02 20:29:48