(31 days)
The SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS, when used in conjunction with SYNCHRON Gentamicin Reagent and Tobramycin Reagent, is intended for use on the SYNCHRON Systems and for the calibration of gentamicin and tobramycin.
The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is for use in the calibration of SYNCHRON Systems Gentamicin and Tobramycin chemistries. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is a liquid human serum matrix to which gentamicin and tobramycin are added.
This is a calibrator for a drug test, not an AI device. The requested information does not apply in this context.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.