DCA Vantage® Analyzer

Basic Information

• Brand Name: DCA Vantage® Analyzer
• Primary DI: 00630414551364
• Version / Model: 10282969
• Catalog Number: 5075US
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2021-11-19
• Public Version Status: Update
• Public Device Record Key: 8ed7e58c-500e-437f-af8e-ebab4ae533b8

Device Description

The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1645	1
CGX	ALKALINE PICRATE, COLORIMETRY, CREATININE	Clinical Chemistry	862.1225	2
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35968	Glycated haemoglobin (HbA1C) analyser IVD	A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414551364	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K071466	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Max 95% RH at 45'c
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius