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K Number
K984006
Device Name
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
Manufacturer
BAYER CORP.
Date Cleared
1999-03-18

(128 days)

Product Code
CGA
Regulation Number
862.1345
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
K043340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GLUCOMETER Elite XL Blood Glucose Meter is used with GLUCOMETER Elite® Test Strips and Controls for the measurement of glucose in whole blood. The GLUCOMETER Elite System is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Description

The GLUCOMETER Elite XL System consists of an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the GLUCOMETER Elite® XL Blood Glucose Meter:

It's important to note that the provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive detail on the full validation study. Therefore, some information, particularly granular details on acceptance criteria and specific performance metrics, is limited.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the GLUCOMETER Elite XL Blood Glucose Meter, as presented in this 510(k) summary, is its equivalence in performance to the predicate device, the GLUCOMETER Elite Blood Glucose Meter. The summary explicitly states: "The results of the evaluation of the GLUCOMETER Elite XL Blood Glucose Meter demonstrate that the new meter is equivalent in performance to the predicate device and suitable for its intended use."

Specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in the provided document. The summary focuses on the comparative nature of the study.

Study Details

  1. A table of acceptance criteria and the reported device performance:

    Acceptance CriteriaReported Device Performance
    Equivalence in performance to the predicate device (GLUCOMETER Elite Blood Glucose Meter)The GLUCOMETER Elite® XL Blood Glucose Meter was demonstrated to be equivalent in performance to the predicate device. The algorithm was modified to provide greater accuracy at low glucose concentrations, suggesting an improvement in this specific aspect while maintaining overall equivalence.

  2. Sample size used for the test set and the data provenance:

    • Sample Size for Test Set: Not explicitly stated. The document mentions the evaluation was "conducted at two clinical sites."
    • Data Provenance: The study was "conducted at two clinical sites," implying a prospective study. The country of origin is not specified, but the submitter is Bayer Corporation, located in Elkhart, IN, USA, suggesting the clinical sites were likely in the USA. The study involved "diabetics and healthcare professionals," indicating real-world usage.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not provided in the given text. For a blood glucose meter, ground truth is typically established using a laboratory reference method, not by human experts.

  4. Adjudication method for the test set:

    • This information is not provided in the given text.

  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:

    • No, this was not a MRMC comparative effectiveness study in the context of AI. This device is a blood glucose meter, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interact with. The study compared the new meter to a predicate meter.

  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Yes, the primary study described is a standalone performance assessment of the GLUCOMETER Elite XL Blood Glucose Meter itself. The device measures blood glucose directly, and its performance (accuracy, precision) is evaluated intrinsically, rather than in conjunction with human interpretation of its outputs. The evaluation demonstrated the equivalence of the meter to the predicate device.

  7. The type of ground truth used:

    • The type of ground truth is implied to be a laboratory reference method for blood glucose measurement. While not explicitly stated, clinical evaluations of blood glucose meters always compare the device's readings against a highly accurate and precise laboratory standard (e.g., hexokinase method, glucose oxidase method on a central lab analyzer). The predicate device's performance would also have been established against such a standard.

  8. The sample size for the training set:

    • This information is not applicable and therefore not provided. The GLUCOMETER Elite XL Blood Glucose Meter is an electrochemical method-based meter. While it has an "algorithm modified to provide greater accuracy at low glucose concentrations," this typically refers to a fixed set of mathematical operations or calibrations rather than a machine learning algorithm requiring a separate "training set" in the modern AI sense. Devices like this are calibrated and validated, not "trained" with a large dataset in the way an AI model is.

  9. How the ground truth for the training set was established:

    • This information is not applicable as there is no mention of a "training set" in the context of AI for this device. The "algorithm modification" would have been developed and refined using standard engineering and calibration techniques, likely with reference to precise lab measurements of glucose at various concentrations.

§ 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.