EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

• K Number: K083099
• Device Name: EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
• Manufacturer: EPS BIO TECHNOLOGY CORP.
• Date Cleared: 2009-01-16 ( 88 days)
• Product Code: NBW
• Regulation Number: 862.1345
• Type: Special
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for the EasyMax N Self-Monitoring Blood Glucose Meter. The document describes the device's indications for use and states that the FDA found it substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain details about specific acceptance criteria for performance, a study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These are typically found in the summary of safety and effectiveness, or detailed study reports which are not included in this letter.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document primarily serves as a regulatory clearance acknowledgment, not a detailed technical performance report.

What is provided in the document:

• Device Name: EasyMax N Self-Monitoring Blood Glucose Meter
• Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips or forearm, for in vitro diagnostic use at home (OTC) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
• Regulatory Information: Class II device, Product Code NBW, CGA, Regulation Number 21 CFR 862.1345 (Glucose test system).
• Predicate Device: The device was found substantially equivalent to legally marketed predicate devices.

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.