CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM

• K Number: K063212
• Device Name: CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer: TaiDoc Technology Corporation
• Date Cleared: 2006-11-22 ( 30 days)
• Product Code: NBW , CGA
• Regulation Number: 862.1345
• Type: Special
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: K070239 , K073119 , K101259

Intended Use

The Clever Chek TD-4231/ Clever Chek TD-4223 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the Clever Chek TD-4231/ Clever Chek TD-4223 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria.

The document is a 510(k) cleared notification from the FDA for a blood glucose monitoring system, the "Clever Chek TD-4231 Blood Glucose Monitoring System" and "Clever Chek TD-4223 Blood Glucose Monitoring System." It states that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing.

The text includes:

• Device Name: Clever Chek TD-4231 Blood Glucose Monitoring System and Clever Chek TD-4223 Blood Glucose Monitoring System
• Regulation Number: 21 CFR 862.1345
• Regulation Name: Glucose test system
• Regulatory Class: Class II
• Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh). Intended for use by healthcare professionals and people with diabetes mellitus at home to monitor diabetes control. Not for diagnosis, screening, or use on neonates. Alternative site testing is for steady-state blood glucose conditions only.

However, it does not provide details on:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any tests.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

This document is a regulatory clearance letter, not a detailed study report.

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.