K-ASSAY MULTI-ANALYTE CALIBRATOR

• K Number: K993853
• Device Name: K-ASSAY MULTI-ANALYTE CALIBRATOR
• Manufacturer: KAMIYA BIOMEDICAL CO.
• Date Cleared: 1999-12-27 ( 45 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 Multi-Analyte Calibrator is intended to be used for the calibration of the following K-ASSAY immunoturbidimetric assays for quantitating serum proteins: Alpha-1 Antitrypsin, Alpha-1 Acid Glycoprotein, C3, C4, IgA, IgG, IgM, Haptoglobin, Transferrin

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "K-ASSAY Multi-Analyte Calibrator." It defines the intended use and regulatory classification of the device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device performance evaluation.

Therefore, I cannot provide the requested information. The text is entirely focused on regulatory approval based on substantial equivalence to a predicate device, not on a detailed performance study of the device itself.

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.