CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

• K Number: K090283
• Device Name: CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
• Manufacturer: GENCHEM, INC.
• Date Cleared: 2009-06-05 ( 120 days)
• Product Code: JIX
• Regulation Number: 862.1150
• Type: Abbreviated
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a medical device (SYNCHRON CX Multi-Analyte Mixture Calibrators 1, 2, and 3) that is substantially equivalent to a legally marketed predicate device. The document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a regulatory approval letter from the FDA.

Therefore, I cannot provide the requested information based on the given document.

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A 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. (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.