External Controls – FOB Rapid Test

External Controls – FOB Rapid Test positive and negative control bottles, CSC47

Ready-to-use positive and negative external controls for the Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test. Includes two 1 mL control bottles. Results are read at 5 minutes. For prescription, in vitro diagnostic use only.

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Product Overview

The External Controls – FOB Rapid Test are ready-to-use positive and negative controls for use with the Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test. The control kit is designed to verify proper test procedure and performance.

The kit contains one 1 mL positive-control bottle with a blue cap, one 1 mL negative-control bottle with a white cap and Instructions for Use. Results are read at 5 minutes when the controls are used with the compatible Accutest ValuPak iFOBT test cassette.

For prescription, in vitro diagnostic use only. Store upright at 2–30°C (36–86°F). Do not freeze.

Two 1 mL Controls

Includes one positive-control bottle and one negative-control bottle.

5-Minute Results

Apply three drops to an Accutest ValuPak iFOBT test cassette and read at 5 minutes.

2–30°C Storage

Store the control bottles upright, either refrigerated or at room temperature.

Key Features

  • Ready-to-use external control kit
  • Designed to verify proper procedure and performance of the Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test
  • One 1 mL positive-control bottle with a blue cap
  • One 1 mL negative-control bottle with a white cap
  • Three drops, approximately 90 µL, used per test cassette
  • Results read at 5 minutes; do not interpret after 10 minutes
  • Store upright at 2–30°C (36–86°F); do not freeze
  • Stable through the expiration date printed on the label
  • For prescription use only
  • For in vitro diagnostic use only
  • Jant catalog number CSC47

Product Specifications

Catalog Number CSC47
Product Name External Controls – FOB Rapid Test
Manufacturer Reference GEFOB-PNK2
Brand Healgen
Product Type External quality controls
Control Materials 1 × 1 mL positive control and 1 × 1 mL negative control
Positive Control Blue-cap bottle; contains 0.2% sodium azide as a preservative
Negative Control White-cap bottle; contains 0.17% sodium azide as a preservative
Compatible Test Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test – Jant catalog number CS425
Control Volume per Test 3 drops (approximately 90 µL)
Result Time Read at 5 minutes; do not interpret after 10 minutes
Testing Temperature Allow the test cassette and controls to reach 15–30°C (59–86°F) before testing
Storage Store packaged at 2–30°C (36–86°F), either refrigerated or at room temperature; keep bottles upright; do not freeze below 0°C (32°F)
Stability Stable through the expiration date printed on the label
Regulatory Use Prescription, in vitro diagnostic use only
Manufacturer Healgen Life Science, LLC

Kit Contents

Positive Control

1 × 1 mL positive-control bottle with a blue cap; contains 0.2% sodium azide as a preservative.

Negative Control

1 × 1 mL negative-control bottle with a white cap; contains 0.17% sodium azide as a preservative.

Also included: 1 Instructions for Use

External Control Procedure

Before testing: Allow the Accutest ValuPak iFOBT test cassette and controls to reach room temperature, 15–30°C (59–86°F).

  1. Remove the Accutest ValuPak iFOBT test cassette from the foil pouch and use it as soon as possible. Best results are obtained if the cassette is used within one hour.
  2. Place the test cassette on a clean, flat surface.
  3. Hold the selected control bottle upright, then unscrew and remove the upper cap.
  4. Squeeze 3 drops (approximately 90 µL) of the control into the sample well and start the timer. Use either the positive or negative control—not both—on one cassette.
  5. Read the result at 5 minutes. Do not interpret the result after 10 minutes.

When to run controls: Run controls once for each new kit lot, each new operator, each new shipment, every 30 days to check storage, or as required by site procedures and local, state and federal regulations or accreditation requirements.

Expected results: A positive control result shows both the control (C) and test (T) lines. A negative control result shows only the control (C) line. If the control line is not visible, the result is invalid; review the procedure and repeat with a new test device.

Important Information

  • For prescription, in vitro diagnostic use only.
  • Use with the Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test. Incompatibilities with other manufacturers’ test kits may occur.
  • Do not use after the expiration date.
  • External controls are quality-control materials and are not intended for testing patient specimens.
  • The positive control is prepared from human blood-derived material. Handle the reagents as potentially infectious using Biosafety Level 2 practices.
  • The controls contain sodium azide. Upon disposal, flush with large volumes of water to help prevent azide buildup in lead or copper plumbing.
  • Wear protective clothing and disposable gloves, and follow Good Laboratory Practices.
  • Store upright at 2–30°C (36–86°F). Do not freeze.
  • Review the official Instructions for Use before performing control testing.

Documentation and Resources

Review the official instructions before using the external controls.

FOB External Controls Instructions for Use View Accutest ValuPak iFOBT Test

Frequently Asked Questions

They are ready-to-use positive and negative external controls designed to verify proper test procedure and performance of the Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test.

Item CSC47 includes one 1 mL positive-control bottle with a blue cap, one 1 mL negative-control bottle with a white cap and one Instructions for Use.

The positive control helps confirm that the test produces the expected positive result, while the negative control helps confirm the expected negative result. Together, they support routine verification of test performance.

These controls are used with the Accutest® ValuPak™ Immunological Fecal Occult Blood (iFOBT) Test, Jant catalog number CS425. The IFU warns that incompatibilities with other manufacturers’ test kits may occur.

Store the controls upright in their packaging at 2–30°C (36–86°F), either refrigerated or at room temperature. Do not freeze below 0°C (32°F). The controls are stable through the expiration date printed on the label.

Run controls once for each new kit lot, each new operator, each new shipment and every 30 days to check storage. Also follow site procedures and applicable local, state, federal or accreditation requirements.

Apply 3 drops, approximately 90 µL, of either the positive control or the negative control to one Accutest ValuPak iFOBT test cassette. Do not apply both controls to the same cassette.

Read the result at 5 minutes. Do not interpret the result after 10 minutes.

No. These are external quality-control materials and are not intended for testing patient specimens.

No. The product labeling identifies the controls as for prescription, in vitro diagnostic use only.

Ordering Information

To place an order, call Jant Pharmacal at 800.676.5565

Catalog Number Description Unit of Measurement
CSC47 External Controls – FOB Rapid Test 1 Kit

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