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510(k) Data Aggregation
K Number
K181915Device Name
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Manufacturer
iXensor Co., LTD.
Date Cleared
2019-04-12
(269 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
iXensor Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus.
The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.
Device Description
PixoTest® POCT System consists of the following devices:
1) PixoTest® POCT Analyzer
Include:
- PixoHealth POCT A1c App
- USB Charger
- USB Type C Charge Cable
- PixoTest POCT Calibration Card
2) PixoTest® POCT A1c Test Kit
Include:
- A1c Test Strip
- Spoit with Latex-Tablet
- Buffer Solution Tube
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