Use Instructions

Instructions For Use
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IFU-3M001-EN-00 (2021.03.05)
LOAA(Lab on An Array) Real-Time PCR Instrument
1. Introduction of LOAA Analyzer
1.1. Intended use of LOAA Analyzer
LOAA Analyzer (Model name: On-Point) is Real-time PCR instrument which is an in vitro diagnostic (IVD) medical device
used to amplify specific genes (DNA or RNA) designed for use with LOAA Dr. PCR cartridges. PCR reaction data is
automatically analyzed by the dedicated software installed in the device and results are delivered to users through on-
screen display or export to external memory for further processing. This device is limited to professional use only.
Figure 1. Appearance of LOAA Analyzer (Model name: On-Point)
1.2. Use restrictions
• This product can only use LOAA cartridges.
• For in vitro diagnostic medical devices only
• Use only the supplied adapter when connecting the device to a power source
• Do not reuse cartridges related to errors, incomplete tests or invalid results
1.3. Dr. PCR Cartridge
LOAA PCR Cartridge (Figure 2) is a disposable and closed-system product containing primers and probes required for
amplification and detection of target nucleic acid samples. The cartridge mainly consists of a CMOS photosensor with a
well array where nucleic acid is amplified, and fluorescence is detected, a microfluidic component where PCR mixture
solution is delivered into each well, and a solid plastic body. Real-time gene amplification (including reverse transcription
PCR) and results analysis are performed through a reader system called LOAA Analyzer. Since all the information for a
diagnostic item and the PCR protocol is written inside the CMOS semiconductor chip, by simply loading the cartridge in the
analyzer real-time PCR can start without any handy PCR parameter setting.
Figure 2. Dr. PCR Cartridge