Reagent, Borrelia Serological Reagent

Device Code: 3460

Product Code(s): LSR

Device Classification Information

• Device Type ID: 3460
• Device Name: Reagent, Borrelia Serological Reagent
• Regulation Description: Treponema Pallidum Treponemal Test Reagents.
• 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: 866.3830 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LSR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-180 CLSI M34-A (Replaces M24-P)
  Western Blot Assay For Antibodies To Borrelia Burgdorferi; Approved Guideline.

Total Product Life Cycle

• Device Type ID: 3460
• Device: Reagent, Borrelia Serological Reagent
• Product Code: LSR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Treponema Pallidum Treponemal Test Reagents.
• CFR Regulation Number: 866.3830 [🔎]

Premarket Reviews
Manufacturer	Decision
Bio-Rad Laboratories
	SUBSTANTIALLY EQUIVALENT	1
BIO-RAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
EUROIMMUN US
	SUBSTANTIALLY EQUIVALENT	2
GOLD STANDARD DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
QUIDEL CORP.
	SUBSTANTIALLY EQUIVALENT	3
QUIDEL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
TRINITY
	SUBSTANTIALLY EQUIVALENT	2
TRINITY BIOTECH
	SUBSTANTIALLY EQUIVALENT	2
VIRAMED BIOTECH AG
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
False Negative Result	16
Incorrect, Inadequate Or Imprecise Result Or Readings	8
False Positive Result	2
Device Displays Incorrect Message	1
Therapeutic Or Diagnostic Output Failure	1
Incorrect Or Inadequate Test Results	1
Total Device Problems	29

TPLC Last Update: 2019-04-02 20:30:33