Intended Use; General Description - Hologic TLi IQ User Manual

For In Vitro Diagnostic Use Only
To be used by trained laboratory personnel

INTENDED USE

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The Hologic TLi System is intended to be used in conjunction with the Rapid fFN Cassette, the Rapid fFN Control Kit,
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and the TLi QCette for the detection of fetal fibronectin in cervicovaginal secretions. Refer to the directional insert for
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the Rapid fFN Cassette for detailed intended use information.

GENERAL DESCRIPTION

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The TLi Analyzer is an electronic optical reflectance device that converts a colorimetric reaction from a cassette into a
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digitized format. The data are analyzed using multiple parameters, including a comparison of sample data to calibration
data. The analyzer provides one of three possible patient test results: Positive, Negative, or Invalid.
The result is positive if the signal intensity derived from the patient sample is greater than or equal to the reference
calibration value specified by the calibration code. The result is negative if the signal intensity derived from the patient
sample is less than the reference calibration value specified by the calibration code. The result is reported as invalid if
specific internal test criteria have not been met.
TLi System User Manual
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Section 1 – Introduction
SECTION I – INTRODUCTION
1 – 1