K-ASSAY MICROALBUMIN CALIBRATOR SET

• K Number: K991166
• Device Name: K-ASSAY MICROALBUMIN CALIBRATOR SET
• Manufacturer: KAMIYA BIOMEDICAL CO.
• Date Cleared: 1999-06-10 ( 64 days)
• Product Code: JIX
• Regulation Number: 862.1150
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The K-ASSAY Microalbumin Calibrator Set is intended to be used for the calibration of the K-ASSAY Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens.

Device Description

Not Found

AI/ML Overview

There is no information in the provided document about acceptance criteria, device performance, sample size for test or training sets, ground truth establishment, or expert involvement. The document is primarily an FDA clearance letter for a medical device (K-ASSAY Microalbumin Calibrator Set) and an "Indications For Use Statement." It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail any specific performance studies or criteria beyond that regulatory determination.

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.