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K Number
K973140
Device Name
DUET GLUCOSE CONTROL MONITORING SYSTEM
Manufacturer
LXN CORP.
Date Cleared
1997-10-31

(71 days)

Product Code
CGA,LCP
Regulation Number
862.1345
Type
Traditional
Panel
CH
Reference & Predicate Devices
K973140
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The DUETTM Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria for the "DUET™ Glucose Control Monitoring System." The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

It includes:

  • Device Name: DUET™ Glucose Control Monitoring System
  • Intended Use/Indications for Use: For the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens, intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting (over-the-counter).

However, it does not provide the following information requested in your prompt:

  1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for the DUET system.
  2. Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set details are provided.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a glucose control monitoring system, not an AI-assisted diagnostic imaging device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not specified, as no study details are provided.
  8. The sample size for the training set: Not applicable, as no algorithm training details are provided.
  9. How the ground truth for the training set was established: Not applicable.

To obtain the information you're looking for, you would typically need to refer to the full 510(k) submission, including the performance data summarized in the submission, which is not part of this FDA clearance letter.

§ 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.