EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR

• K Number: K080404
• Device Name: EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
• Manufacturer: MEDICA CORP.
• Date Cleared: 2009-03-13 ( 393 days)
• Product Code: JIX , JIT , JJR , JJY
• Regulation Number: 862.1150
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

MEDICA's EasyQC - Chemistry, Levels A and B, is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

MEDICA's EasyElectroLytes kit is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

MEDICA's EasyQC - Chemistry and Electrolytes, Levels A and B is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

MEDICA's EasyCal - Multiconstituent Calibrator is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of a number of analytes in human serum.

MEDICA CREA-U Cal is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of Creatinine in urine.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval by the FDA for Medica Corporation's quality control materials and calibrators for clinical chemistry. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it confirms that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory approval rather than a detailed technical performance study with acceptance criteria.

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.