EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.

• K Number: K013342
• Device Name: EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
• Manufacturer: CHAY MEDICAL, LLC.
• Date Cleared: 2002-02-15 ( 129 days)
• Product Code: CGA , NBW
• Regulation Number: 862.1345
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Excelsior blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters. Excelsior test strips, when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters, quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

Device Description

Excelsior blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX Dood glucose system, and Prestige IQ blood glucose system.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device (Excelsior Blood Glucose Test Strips). It states that the device is substantially equivalent to a legally marketed predicate device.

This document does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

FDA 510(k) clearance letters primarily focus on the determination of substantial equivalence, not a detailed breakdown of clinical study results or technical performance metrics used in the study submitted to support the 510(k). The detailed performance data would typically be found within the 510(k) submission itself, which is not provided here.

Therefore, I cannot provide the requested information based on the given text.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.