Immunohistochemistry Antibody Assay, Estrogen Receptor

Device Code: 4894

Product Code(s): MYA

Device Classification Information

• Device Type ID: 4894
• Device Name: Immunohistochemistry Antibody Assay, Estrogen Receptor
• Regulation Description: Immunohistochemistry Reagents And Kits.
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.1860 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MYA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-219 CLSI I/LA28-A2
  Quality Assurance For Design Control And Implementation Of Immunohistochemistry Assays; Approved Guidelines-Second Edition.

Total Product Life Cycle

• Device Type ID: 4894
• Device: Immunohistochemistry Antibody Assay, Estrogen Receptor
• Product Code: MYA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunohistochemistry Reagents And Kits.
• CFR Regulation Number: 864.1860 [🔎]

Premarket Reviews
Manufacturer	Decision
DAKO A/S
	SUBSTANTIALLY EQUIVALENT	1
LEICA MICROSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Insufficient Information	2
Heater	1
Fluid Leak	1
False Negative Result	1
Slide	1
Improper Or Incorrect Procedure Or Method	1
None	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Ventana Medical Systems Inc	I	Sep-14-2018

TPLC Last Update: 2019-04-02 20:57:09