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Rapid fFN 10Q
System User Manual
Section 1 — Introduction
SECTION I — INTRODUCTION
For
In Vitro
Diagnostic Use Only
To be used by trained medical personnel
INTENDED USE
The Hologic Rapid fFN
®
10Q System is an
in vitro
diagnostic device intended to be used in conjunction with the
Rapid fFN 10Q Cassette, the Rapid fFN Control Kit, and the Rapid fFN 10Q QCette for the detection of fetal
fi bronectin (fFN) in cervicovaginal secretions. Refer to the directional insert for the Rapid fFN 10Q Cassette for
detailed intended use information.
GENERAL DESCRIPTION
The Rapid fFN 10Q Analyzer is an electronic optical refl ectance device that converts a colorimetric reaction from
a cassette into a digitized format. The data are analyzed using multiple parameters, including a comparison of
sample data to calibration data. The analyzer reports the fFN concentration in the clinical specimen.
The analyzer reports fFN concentrations ranging from 0–500 ng/mL. Concentrations greater than 500 ng/mL are
reported as >500 ng/mL. The result is reported as invalid if specifi c internal test criteria have not been met.
Summary of Contents for Rapid fFN 10Q
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