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510(k) Data Aggregation
K Number
K230878Device Name
QScout Lab; QScout RLD
Manufacturer
Ad Astra Diagnostics, Inc.
Date Cleared
2023-11-14
(229 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
Ad Astra Diagnostics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDT A whole blood:
- White blood cell count (WBC)
- · Neutrophils (NEUT#)
- · Lymphocytes (LYMPH#)
- · Monocytes (MONO#)
- · Eosinophils (EOS#)
- · Basophils (BASO#)
- · Immature Granulocytes (IG#)
- · Percent Neutrophils (NEUT%)
- Percent Lymphocytes (LYMPH%)
- · Percent Monocytes (MONO%)
- · Percent Eosinophils (EOS%)
- · Percent Basophils (BASO%)
- · Percent Immature Granulocytes (IG%)
- · Neutrophil to Lymphocyte Ratio (NLR)
Device Description
The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. It includes the QScout Lab analyzer, the QScout RLD (Rapid Leukocyte Differential) test, software, and handheld barcode scanner. The QScout system reports white blood cell count and neutrophil to lymphocyte ratio and enumerates and classifies six white blood cell types including immature granulocytes.
The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.
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