For In Vitro Diagnostic Use Only

For In Vitro Diagnostic Use Only

Store at room temperature (15° to 30°C / 59° to 86°F). Do not freeze.

QC ette

®

The Adeza Biomedical TLi

IQ

QCette

®

is a quality control device used to monitor the performance of the TLi

IQ

®

Analyzer.

F or Professional Use Only

INTENDED USE

“Authorized Representative”

according to IVDD 98/79/ EC

MDSS

Burckhardtstrasse 1

30163 Hannover, Germany

REF 01175

The TLi

IQ

QCette is a quality control device used to verify that the TLi

IQ analyzer performs within specification. The QCette Setup software determines a value for the QCette. Daily quality control data collected from the QCette are automatically compared to this setup value to verify analyzer performance.

PRECAUTIONS AND WARNINGS

2. Do not use the QCette if it is damaged.

STORAGE AND STABILITY

The QCette should be stored at room temperature (15° to 30°C / 59° to

86°F) in the container provided. Do not store in the cassette insertion site of the analyzer. Do not use the QCette unless it is clean and free of lint or moisture. If properly stored, the QCette should last an indefinite period of time.

MATERIALS REQUIRED BUT NOT PROVIDED

TLi

IQ

Analyzer, Printer, and User Manual

PROCEDURE

INITIAL TLi

IQ

QCette SETUP

Note: Setup is performed once for the QCette received with the TLi

IQ

System.

1. From the Main Menu, select CHANGE SETUP.

2. Select QCette SETUP from the SETUP menu and enter the information requested until the analyzer prompts to insert QCette.

Insert QCette and press enter. Setup of the QCette will take approximately 15 minutes.

3. Upon completion, the analyzer will display either SETUP

COMPLETE or SETUP ERROR. Setup Error indicates that the performance criteria of the analyzer have not been established (see the TLi

IQ

User Manual for details).

DAILY TLi

IQ

QCette USE

Note: Daily running of the QCette is a quality control method for analyzer performance.

1. From the Main Menu, select DAILY QC.

2. Enter the information requested until the analyzer prompts to insert

QCette. Insert QCette and press enter. Analysis of the Qcette will take approximately 2-3 minutes.

3. The result for the QCette will be displayed on the analyzer display screen and automatically printed as SYSTEM PASS, SYSTEM

FAIL, or INVALID.

INTERPRETATION OF RESULTS

The TLi

IQ

QCette is a daily quality control test to verify that the performance of the TLi

IQ

analyzer is within specification.

The TLi

IQ

QCette is a Rapid fFN Cassette replica containing a membrane with printed test and control lines, which is read by the TLi

IQ analyzer. Three different levels of response are measured with this QC device:

1) High Level: The blue line at the procedural control position, which is in the high positive range, must be above a minimum threshold value for QC to pass.

2) Low Level: The blue printed line at the test line position is in the cutoff range. This line is measured and compared with a value established during instrument setup and must be within 5% of that value for QC to pass.

3) Negative: The white space between the blue lines is measured and should always be in the negative range for QC to pass.

A “PASS” result indicates that the daily QCette value is within the specification determined at setup. A “FAIL” result indicates that the daily QCette value is outside the specification determined at setup.

If the QCette fails, ensure that it is clean and free of lint or moisture, and repeat the test. If there is dirt or lint on the QCette, a "canned air" product may be used. If the problem persists, see the TLi

IQ

User Manual for further details, or contact Adeza Biomedical for technical assistance.

QUALITY CONTROL PROCEDURES

Current Good Laboratory Practice includes the periodic use of controls to monitor assay performance. The QCette is recommended for use in monitoring the performance of the analyzer. The recommended frequency of use of the QCette is at least once every 24 hours, or

whenever there is uncertainty about the analyzer. Do not test patient samples until an acceptable result is obtained from the QCette.

The TLi

IQ

QCette is covered by U.S. patent number Des. 432,244.

© 2003 Adeza Biomedical Corporation. All rights reserved.

The Adeza logo, TLi

IQ

, and TLi

IQ

QCette are registered trademarks of Adeza

Biomedical.

TECHNICAL SERVICE AND ORDERING INFORMATION

USA ONLY

Customer Support: 1-877-945-0208

Order Info: 1-888-PRETERM

(1-888-773-8376)

Fax: 1-913-859-6998

OUTSIDE OF THE USA

Tel: +1-408-745-0975

Fax: +1-408-745-0208

Toll Free Order Info: +1-888-567-3817

Tech Service: +1-877-945-0208

Adeza Biomedical Corporation

1240 Elko Drive

Sunnyvale, CA 94089-2212 USA October 2003

www.adeza.com 01173:07