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K Number
K091898
Device Name
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
Manufacturer
TaiDoc Technology Corporation
Date Cleared
2009-09-18

(86 days)

Product Code
NBW,CGA
Regulation Number
862.1345
Type
Special
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
K100405
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The FORA G90 / U-Right TD-4234 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, nor is it intended for use on newborns.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the FORA G90 / U-Right TD-4234 Blood Glucose Monitoring System, which states that the device is substantially equivalent to a legally marketed predicate device.

The document discusses:

  • The FDA's review of the premarket notification.
  • The device's classification and regulation details.
  • General controls provisions and other regulatory requirements.
  • The instructions for use and indications for the device.

It does not include any information about:

  • Specific acceptance criteria (e.g., accuracy percentages, limits of agreement).
  • A study's design, results, or comparison to acceptance criteria.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Details about establishing ground truth.
  • Information on MRMC studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

§ 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.