in2it (II) Analyzer

Quality with Every in2it™ Result

Bio-Rad provides superior results you can trust time after time. The cornerstones of Bio-Rad A1c products are consistent reproducibility and accuracy, providing you with reliable results for improved patient care. in2it Results Are: Reproducible — Laboratory precision produces consistent results with minmal variation. Accurate — Result comparison with NGSP reference values assigned using HPLC.

*Average of seven samples per range

in2it™ A1C Test Procedure

1. Getting Started

• Test cartridges must be warmed to room temperature
• Consult the user manual for instructions on collecting control or venous samples

	A. When the in2it is ready to run a test, the cartridge symbol will flash. Press the middle button (under the cartridge symbol) to start a test.		D. With a sterile lancet, prick the patient's finger and gently squeeze to obtain a generous drop of blood.
	B. The in2it door will open. It is ready to accept a cartridge.		E. Holding the blood key by the round handle, touch the flat end to the blood drop. Blood will automatically flow into the key. Take care not to get blood on the outside of the blood key.
	C. Place a cartridge in the workstand with the blue blood port facing up.

2. Insert Blood Key into Cartridge

• Proper insertion of blood key into the test cartridge is essential.
  See Quick Reference Guide.

	A. Align Properly align the blood key prior to pressing the key through the blue blood port. The winged flanges on the blood key must face the same direction as the notch in the blood port.		C. Push Press firmly down on the blood key until it locks in position. You may feel two seperate and distinct cycles
	B. Pierce Pierce the film covering the blue blood port. The blood key will drop slightly into the port.		D. Twist Twist the handle of the blood key until it snaps off.

3. Place Cartridge into Instrument

	A. Immediately (within 10 seconds), place the cartridge in the door with the white plate facing inward and the blue blood port facing up.		C. When the test is completed, the result will be displayed. Record the result.
			D. Press the cartridge symbol button to open the door and remove the cartridge. After removing the cartridge, press the OK button to close the door prior to running the next test.
	B. Immediately (within 10 seconds), press the OK button to close the door. Testing will start automatically.

4. Results Displayed in 10 Minutes

Improved Patient Care

Studies show that discussing A1C results with patients in realtime significantly improves glycemic control. A1C levels were reduced up to 1.44% A1C after 6 months and up to 1.65% A1C after 12 months in the immediate assay group compared to the control group.*

* E. Cagliero et al. Immediate Feedback of HbA1c Levels Improves Glycemic Control in Type 1 and Insulin-Treated Type 2 Diabetic Patients. Diabetes Care, Vol. 22, No. 11, November 1999.

in2it Is Easy to Use

The in2it is CLIA waived,¹ fully automated, and easy to use. in2it results are obtained
using a 3-step process, simplifying instrument operation and staff training.

¹ 510(k) cleared for prescription home use and, accordingly, is CLIA waived.

in2it Delivers Reliable Results

The in2it correlates closely to established HPLC laboratory methods. In studies using HPLC instruments, the correlation values were accurate and reproducible. This level of correlation ensures that the results generated in your office will closely match laboratory results.

Reproducible — Laboratory precision produces consistent results with minimal variation.

Accurate* — Result comparison with NGSP reference values assigned using HPLC.

* Average of seven samples per range

in2it Results Are Reimbursable

• The A1C CPT code is 83037QW the United States Medicare reimbursement limit is $14.17 per test
• in2it reduces costs by eliminating the need for A1C send-out testing