The Rapid ResponseTM Gluco-MD Blood Glucose Monitoring System consists of the blood glucose meter, test strips and control solutions which have been designed to work together to produce accurate blood glucose test results, to aid in the management of diabetes. It is intended for in vitro diagnostic use at home and in clinical settings only. Test results can be expressed on screen in either milligrams of glucose per decilitre of blood (mg/dL) or millimoles of glucose per liter of blood (mmol/L).

Features include:
• Large LCD display
• 7-second reaction time
• Indicates ketone warning
• Single button operation
• Contains strip ejector
• Requires only 0.7µL blood

The Rapid ResponseTM Gluco-MD Blood Glucose Monitoring System is CLIA Waived and Health Canada licensed.

Product Information
  • Product Code: 04GLU-67NC
  • Sample: N/A
  • Sensitivity: 20 - 599 mg/dL
  • Specificity: Blood Glucose
  • Accuracy: Please contact us for details
  • Time-to-Result: 7 seconds
  • Storage Condition: -4 - 140°F/-20 - 60°C
  • Test Principle: Glucose Oxidase (A. niger)
Contents
  • Meter
  • 10x sterile lancets
  • Owner’s manual
  • Storage case
  • Quick start user guide
  • Lancing device with clear cap
  • Daily log book
  • Warranty card

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Frequently Asked Questions (FAQ)

Answer: Yes, Lochness Medical Inc. Rapid Response Fecal Immunochemical Test (FIT) Kit is (FDA) Cleared and waived by the Clinical Laboratory Improvement Amendments (CLIA).

Answer: Yes, The 2008 American College Of Gastroenterology Guidelines for Colorectal Cancer Screening states: “The preferred cancer detection test is annual FIT. This test has superior performance characteristics when compared with older guaiac-based Hemoccult II cards (15 – 17) 1

Answer: Yes, the Rapid Response Fecal Immunochemical Test (FIT) Kit has an accuracy of 98%. The Guaiac based test(s) / Hemoccult Cards has an accuracy of 86%. The Guaiac based test(s) /Hemoccult Cards requires 3 stool samples on 3 different days (300,000 ng/mL sensitivity). The Rapid Response Fecal Immunochemical Test (FIT) Kit requires only 1 stool sample (50 ng/mL sensitivity). Patients must avoid Aspirin, Red meat, Vitamin C, Fruit Juices before they take a test that’s Guaiac based/Hemoccult Cards. There aren’t any dietary restrictions for the Rapid Response Fecal Immunochemical Test (FIT) Kit. Patients who conduct the FIT Test at their residence returns only the FIT Buffer Tube. The Guaiac based test(s) / Hemoccult Cards causes patients to return a stool sample, which can be messy.

Answer: The Sample Collection for the ICT may be described as messy, protracted and associated with low compliance. The Sample Collection for the FIT Test may be described as simple, one-step, hygenic and high compliance. The FIT Test is more sensitive than ICT (50 ng/mL versus 75 ng/mL).The Positive and Negative agreement between the two test approaches 100%.

Answer: No, Lochness Medical Inc. Fecal Immunochemical Test (FIT) Kit does not have any dietary restrictions.

Answer: No, Lochness Medical Inc. Fecal Immunochemical Test (FIT) Kit does not have any medical restrictions.

Answer: Store test device at room temperature (15-28°C or 59-82.4°F). Refer to the expiration date printed on the foil pouch for stability. Sample collection tube after collecting sample should be stored refrigerated (2-8°C or 35.6-46.4°F) if not used immediately.

Answer: The kit contains 36 test devices, 36 sample collection tubes, and 1 package insert.

Answer: The Rapid Response Fecal Immunochemical Test (FIT) Test Kit is 98% accurate.

Answer: No, the Rapid Response Fecal Immunochemical Test (FIT) Test is specific to human hemoglobin.

Answer: The analytical sensitivity of the Rapid Response Fecal Immunochemical Test (FIT) Test is 50 ng hHb/ml buffer or 5 ug hHb/g feces.

Answer: The false positives for the Rapid Response Fecal Immunochemical Test (FIT) Test Kit are roughly 6%. However, it is looking for human hemoglobin (blood), not paroxadais activity. When a FIT Test has a positive test result, there’s the assurance that blood is in the stool. This could be indicative of diverticulitits, colitis, Chron’s disease, hemorrids, etc.

Answer: No, the Rapid Response Fecal Immunochemical Test (FIT) Test is specific to human hemoglobin.

Answer: Yes, you can take the FIT test regardless of menstruation.

Answer: The shelf life is 24 months from the date of manufacture.

Answer: The national average insurance reimbursement for the Rapid Response Fecal Immunochemical Test (FIT) Test Kit is $21.86.

Answer: No, the CPT Codes are 82274QW for insurance and G0328QW for Medicare.

Answer: Yes, Lochness Medical Inc. offers FIT Mailers separately. The kit contains 50 FIT Mailers. The product code is FOB-9V30.

Answer: Unscrew the cap with the spiral applicator from the sample collection tube. Use the spiral applicator to poke into the stool at 6 different sites. Collect the amount necessary to only cover the grooves of the spiral applicator. More information about collecting sample specimen can be found in the FIT Mailers’ Manual/Quick Card.2

Answer: Yes, the collection paper’s material allows the convenience to flush it down the toilet.

Answer: No, the Rapid Response Fecal Immunochemical Test (FIT) Test is specific to human hemoglobin.

Answer: Specimen can be left in the collection tube for 7 days at room temperature and 14 days refrigerated.

1. Rex,MD,FACG, Douglas K., David A. Johnson, MD, FACG, Johnson C. Anderson, MD, Phillip S. Schoenfeld,MD,MSEd, MSc,(Eqi), Carol A. Burke,MD,FACG, and John M. Inadomi, MD,FACG. "American College of Gastroenterology Guidelines for." 104. (2009): n. page. Web. 11 Feb. 2014.

3. Rapid Response® (FIT) Mailers Manual/Quick card, rev. 2013