OUL · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2310
Classification
FDA Product Code
OUL
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.2310
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run. It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats.