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A-PON™ Device Instructions For Use

Intended Use

The GattaCo A-PON™ Plasma Separator is a single-use liquid plasma separation device from peripheral blood samples.

Device Description

The A-PON device is a disposable plasma separation device that collects capillary/peripheral whole blood expressed by lancet from a finger, heel, or other appropriate extremity. The device collects the blood passively via a capillary collection tube which is coated with dried EDTA or Li Heparin anticoagulant; the blood mixes with the EDTA to prevent the blood from clotting. As the blood flows passively through the device by capillary action, it passes through a porous membrane that separates blood cells and platelets from the anticoagulated plasma. The plasma collects in the device’s plasma reservoir. Once the plasma reaches the Liquid Color Indicator (LCI) it will change color from white to black which indicates the completion of the collection step. The plasma collection reservoir is connected to an air-filled bulb; when the bulb is squeezed using the user’s fingertip, the plasma is pushed out of the device’s exit aperture into a suitable low-volume and low- analyte binding specimen cup or collection test chamber.

Disposal

The device can be disposed according to local or state guidelines for disposal of micro volumes of blood.

Symbol

Catalogue Number

Manufacturer

Batch Code

Expiration Date

Number of Tests

Single Use Only

Do not use if package is damaged

Keep away from sunlight

Keep Dry

Store at 15-30oC

Instructions

Consult Instructions for Use

Transport at 15-85% RH

Warning

The device is a one-time use device to separate fresh plasma from a finger stick. Do not use for more than single sample processing. The device will not separate plasma or work properly if used for more than one sample, or if the volume of the sample is different than the volume marked by the collection fill arrow.

Precaution

  • Follow user instructions.
  • The device is for one time use. Discard the device after use.
  • Do not use the device after expiration date.
  • The device should be filled properly as indicated in the user instructions. Blood will not fill properly if the device orientation is incorrect.
  • Plasma will not separate properly if the device is not in the correct orientation after filling the inlet with blood. The device should be filled while laying horizontally on a flat surface. The blood should be filled in the capillary until it reaches the arrow location. The device should be placed upright after collecting blood to allow blood to enter the separation chamber and start plasma separation.
  • Wait for the LCI to change color before dispensing. Dispensing the plasma before the indication of the Liquid Color Indicator (LCI) will result in incomplete collection of the plasma.
  • The dispensing bulb should be pressed slowly, and continuously until plasma is dispensed into the collection container. Fast dispensing/actuation can result in dispensing failure.
  • Obtain proper accessories before opening the device.
  • Do not use the device if the packaging is found open.
  • Use the device within 20 minutes of opening the pouch.
  • Store in a dry environment.
  • Store at room temperature and away from direct sunlight.
  • Use personal protective equipment when handling

Materials Provided

GattaCo A-PONTM Plasma Separator Device

Materials Required
(Not Provided - Sold Separately)

  • Lancets
  • Alcohol Swab
  • Gauze
  • Bandage
  • Biohazard Bag
  • Transfer Tube

A-PON™ Device Instructions For Use

26442 Beckman Court Murrieta, CA, USA 92562

+1-951-331-3050

info@gattaco.com

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© 2023 GattaCo Inc. All Rights Reserved.
A PON™ Plasma Separator is registered with the US FDA as a Class-I Medical Device.
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Select Package

A-PON™ Plasma Separator - 25 Pack

  • Blood Input: 75 µL via integrated EDTA-coated capillary
  • Plasma Output: 14 µL +/- 3.5%
  • Plasma Separation & Collection Time: < 5 minutes
  • Plasma Quality: Clear with no visible cellular content

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A-PON™ Plasma Separator and Lancet Pack

  • Individual accessory items listed below, all packaged together in a single shipper box:
  • 1x - A-PON Plasma Separator
  • 1x - Alcohol wipe
  • 1x - Gauze pad
  • 2x - Lancets
  • 1x - Bandage
  • 1x - Plasma sample collection tube
  • 1x- Biohazard bag
  • 1x- Padded mailer envelope

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