VITROS CHEMISTRY PRODUCTS PHBR SLIDES

• K Number: K984288
• Device Name: VITROS CHEMISTRY PRODUCTS PHBR SLIDES
• Manufacturer: Ortho-Clinical Diagnostics, Inc.
• Date Cleared: 1999-01-26 ( 56 days)
• Product Code: DLZ
• Regulation Number: 862.3660
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

For in vitro diagnostic use only. VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "VITROS Chemistry Products PHBR Slides." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics against specific acceptance criteria. The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent for its intended use, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the given input, as the document does not detail device performance, study designs, sample sizes, ground truth establishment, or expert adjudication methods.

Regulation Number and Section

§ 862.3660 Phenobarbital test system.

(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.