Details for MD-4

Company Name: HemexDx Private Limited

Company Address: 1208, 12th Floor, Real Tech Park,, Sector No 30A Plot No 39/2 Near
Vashi Railway Station, Vashi, Thane, Maharashtra, 400703
Telephone: +917045070662

Manufacturer Name: LAKSHMI LIFE SCIENCES PRIVATE LIMITED,

Manufacturer Address: 3/245, Old No 3/284A Sulur Railway Feeder

Road, ,Muthugoundenpudur Post., Coimbatore, Tamil Nadu (India) - 641406

Telephone No.: 04224560163,04224560112

FAX: 04222220912 has been licensed to manufacture for sale or for distribution the below
listed medical device(s) at the premises situated at M/s LAKSHMI LIFE SCIENCES PRIVATE
LIMITED, 3/245, Old No 3/284A Sulur Railway Feeder Road, Muthugoundenpudur
Post ,Coimbatore, Tamil Nadu (India) - 641406 Telephone No.: 04224560163
FAX: 04224560114

Generic Name of Product: Hb Variant Test Multipack

Brand Name: Gazelle

Intended Use (for buffer, cartridge, marker fluid): From the IFU:
Gazelle™ Hb Variant is an in vitro diagnostic test intended for quantitative
measurement of hemoglobin A, F, S, A2/ C/E using cellulose acetate electrophoresis. It
uses the Hb Variant Test Multipack, including cartridges. The test also provides an
interpretation of the results. The test is for professional use in a lab setting and requires
human whole blood from patients.

Model No.: NIL

Class of medical device: Class B

Material of Construction (for buffer, cartridge, marker fluid)

- Buffer: TBE Buffer, Synperonic F 108 Surfactant, Type 1 Quality Water
- Marker Fluid: Xylene Cyanol Powder, Type 1 Quality Water, Saponin
- Cartridge: Polystyrene

Dimensions (for buffer, cartridge, marker fluid)

 - Buffer Vol. 45 mL
- Marker Fluid Vol. 5 mL
- Cartridge: 25mm x 58.6mm x 8.1mm

Pack size
- Hb Variant Test Multipack contents:
25 Hb Variant Cartridges
25 Hb Variant Stampers
1 Hb Variant Stamper Stand
1 Bottle Hb Variant Marker Fluid 5mL
1 Bottle Hb Variant Buffer 45 mL
Instructions for Use

Shelf life (for buffer, cartridge, marker fluid)

- Buffer: 2 years
- Marker Fluid: 2 years
- Cartridge: 2 years

Storage Condition (for buffer, cartridge, marker fluid)

- Buffer: 5%-95% relative humidity, 5°C-45°C temperature
- Marker Fluid: 5%-95% relative humidity, 5°C-45°C temperature
- Cartridge: 5%-95% relative humidity, 5°C-45°C temperature

Product Description: From the IFU:

Overview
Gazelle™ Hb Variant is an in vitro diagnostic device that can aid clinicians in the
diagnosis of certain hemoglobin abnormalities.

The Gazelle Hb Variant test uses a miniaturized version of electrophoresis technology

for hemoglobin variant detection. It identifies and quantifies Hb A (normal), Hb S
(sickle), Hb F (fetal) and Hb A2/C/E. The Reader uses this information to offer
interpretative statements for possible conditions such as sickle cell disease and trait,
and certain thalassemias. A small sample consisting of whole blood and marker fluid
(which serves as a control) is lysed and applied to the cartridge, which is then placed
into the Reader for analysis. In about 8 minutes, the Reader displays the result on the
screen, including hemoglobin types and percentages. Interpretative statements are
also presented on the screen.

Gazelle consists of a Reader and Gazelle™ Hb Variant Test Multipack. Test results
are stored digitally on the Reader and can be printed or transferred to a USB
drive.
Principle of Procedure
Microchip electrophoresis: Gazelle uses a miniaturized version of the gold standard
test known as electrophoresis. When the disposable cartridge containing a lysed blood
sample is inserted into the Reader, the hemoglobin types are separated according to
their charge. In about 8 minutes, the interpretation (normal, trait, disease) as well as
the types and percentages of hemoglobin are displayed on the screen and stored
digitally.

Gazelle separates hemoglobin types in a small volume of blood on a piece of cellulose

acetate paper that is housed in a cartridge. The basis of Gazelle’s technology lies in
hemoglobin electrophoresis in which different hemoglobin types, including A
(normal), S (sickle), C (hemoglobin C disease), A2, E (hemoglobin E disease), and F
(fetal) have different net negative charges in an alkaline solution and will move across
the paper at different speeds due to an applied voltage. The different hemoglobin
types will separate into visible bands on the paper.

The Gazelle Reader contains custom software which controls the user interface,
voltage/current used in the electrophoresis process, video and image capture over the
duration of the test, imaging analysis algorithms, data storage, and data transfer. The
image analysis algorithm extracts the image characteristics of the hemoglobin bands
to determine the type of hemoglobin as well as its relative amount. This information is
used to offer an interpretative statement based on hemoglobin proportions.