VANCOMYCIN EIA ASSAY

• K Number: K983280
• Device Name: VANCOMYCIN EIA ASSAY
• Manufacturer: DIAGNOSTIC REAGENTS, INC.
• Date Cleared: 1998-11-06 ( 49 days)
• Product Code: LEH
• Regulation Number: 862.3950
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the Vancomycin Enzyme Immunoassay. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission document itself, not in the FDA's approval letter.

Therefore, I cannot fulfill your request with the given input. The document is solely an approval stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Regulation Number and Section

§ 862.3950 Vancomycin test system.

(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.