ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03

• K Number: K991870
• Device Name: ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
• Manufacturer: A.P. TOTAL CARE, INC.
• Date Cleared: 1999-07-30 ( 59 days)
• Product Code: CGZ , CEM , JGS
• Regulation Number: 862.1170
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The ISE Electrolyte (Na+, K+ and Cl-) reagents, product No. 114-01, 1114-02 and 114-03 are intended for Invitro Diagnostic use in the automated, quantitative determination of sodium, potassium and chloride in serum, or plasma.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an "ISE Electrolytes" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process and the substantial equivalence determination.

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.