MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL

• K Number: K040670
• Device Name: MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
• Manufacturer: HOME DIAGNOSTICS, INC.
• Date Cleared: 2004-03-25 ( 10 days)
• Product Code: NBW
• Regulation Number: 862.1345
• Type: Special
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary from the FDA for the "TrueTrack Smart System Blood Glucose Monitoring System". While it states that the device is substantially equivalent to a legally marketed predicate device, it does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

Specifically, the document does not include any of the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on the FDA's determination of substantial equivalence based on the provided indications for use and general compliance with regulations. It does not detail the specific performance studies and their results.

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.