System, Hemoglobin, Automated

Device Code: 2316

Product Code(s): GKR

Device Classification Information

• Device Type ID: 2316
• Device Name: System, Hemoglobin, Automated
• Regulation Description: Automated Hemoglobin System.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• CFR Regulation Number: 864.5620 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GKR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-71 CLSI H15-A3 (Replaces H15-A2)
  Reference And Selected Procedures For The Quantitative Determination Of Hemoglobin In Blood; Approved Standard - Third Edition

Total Product Life Cycle

• Device Type ID: 2316
• Device: System, Hemoglobin, Automated
• Product Code: GKR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Hemoglobin System.
• CFR Regulation Number: 864.5620 [🔎]

Premarket Reviews
Manufacturer	Decision
EKF-DIAGNOSTIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMMUNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
RADIOMETER MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	5
Computer Software Problem	4
High Test Results	3
Low Test Results	2
Device Issue	1
Device Handling Problem	1
Incorrect Or Inadequate Test Results	1
Output Problem	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	19

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics, Inc.	II	Aug-24-2018
2	Stanbio Laboratory, LP	II	Aug-24-2018

TPLC Last Update: 2019-04-02 20:09:34