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Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 201 Analyzer. The HemoCue® Hb 201 DM System is used for the quantitative determination of hemoglobin in blood using specially designed analyzer, the HemoCue® Hb 201 DM Analyzer and specially designed microcuvettes, the HemoCue® Hb 201 Microcuvettes. The HemoCue Hb 201 DM Analyzer is only to be used with HemoCue® Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201 DM Analyzer is only to be used together with HemoCue Hb 201 Microcuvettes. The use of any other device in the HemoCue Hb 201 DM Analyzer except the HemoCue 201 Microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequence. The HemoCue Hb 201 microcuvettes are for in vitro use only.

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This document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. While it generally refers to performance, it does not provide detailed acceptance criteria and a study demonstrating the device meets those criteria in the way a clinical study report would.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document only states the device is "substantially equivalent" to legally marketed predicate devices. It does not list specific performance metrics or their acceptance thresholds.
• Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or its origin.
• Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment details are absent.
• Adjudication method for the test set: No test set means no adjudication method described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The HemoCue Hb 201 DM System is an automated hemoglobin system, inherently operating in a standalone manner for measurement, but the document doesn't detail performance studies.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on how ground truth was established for any performance comparison.
• The sample size for the training set: There is no mention of a "training set" as this is a medical device clearance, not an AI model approval with a distinct training phase.
• How the ground truth for the training set was established: Not applicable, as no training set is discussed.

Information that can be inferred or directly stated from the document:

• Device Name: HemoCue® Hb 201 DM System
• Intended Use: Quantitative determination of hemoglobin in capillary, venous, and arterial whole blood.
• Regulatory Status: Cleared by FDA via 510(k) as substantially equivalent (K041234).
• Nature of the device: An automated hemoglobin system using a specific analyzer (HemoCue® Hb 201 DM Analyzer) and microcuvettes (HemoCue® Hb 201 Microcuvettes).

To answer the requested questions about acceptance criteria and study details, a different type of document, such as a clinical study report or detailed device validation report, would be required. The provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence, but it does not delve into the specifics of performance studies as requested.

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Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

The HemoCue Glucose 201 DM System consists of the HemoCue Glucose 201DM Analyzer and HemoCue Glucose 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes.

The provided text is a 510(k) clearance letter from the FDA for the HemoCue® Glucose 201 DM System. It primarily addresses regulatory approval and does not contain detailed information about the acceptance criteria or a specific study proving the device's performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based only on the provided text, with significant limitations:

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

This information is not present in the provided document. The document is a regulatory clearance letter, not a detailed study report.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

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

This information is not present in the provided document. The device in question is a glucose measurement system, not an AI-assisted diagnostic imaging tool, so an MRMC study with human readers assisting AI would not be applicable.

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

The device is a "Glucose 201 DM System" which includes an analyzer and microcuvettes. This implies it is a standalone analytical system for measuring glucose. However, the document does not explicitly describe any standalone performance study details, only that it's a "quantitative determination of glucose."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a glucose test system, the ground truth would typically be established by a reference laboratory method (e.g., hexokinase method). However, this specific detail is not present in the provided document. The document mentions "quantitative determination of glucose in whole blood" and "instant blood glucose concentration," indicating a direct measurement, but not the gold standard used for comparison.

8. The sample size for the training set

This information is not present in the provided document.

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

This information is not present in the provided document.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory approval of the HemoCue® Glucose 201 DM System based on substantial equivalence to a predicate device. It does not contain the detailed technical performance data, study design, or ground truth methodology that would typically be found in a clinical study report or a more comprehensive submission document.

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Quantitative determination of hemoglobin in capillary, venous and arterial whole blood.

The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes.

The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201* analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences.

The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.

Not Found

This document provides an FDA 510(k) clearance letter for the HemoCue® Hb 201+ System but does not contain the detailed study information required to fully answer your request. The letter confirms the device's substantial equivalence to predicate devices and states its indications for use. It does not include acceptance criteria, specific performance data from studies, sample sizes, ground truth establishment, or any information about expert participation or multi-reader studies.

Therefore, I cannot provide the requested table and detailed study information based solely on the provided text.

The available information from the document is:

• Device Name: HemoCue® Hb 201+ System
• Intended Use: Quantitative determination of hemoglobin in capillary, venous, and arterial whole blood.
• Components: HemoCue® Hb 201+ analyzer and HemoCue® Hb 201 Microcuvettes.
• Regulatory Status: Cleared through 510(k) process, determined substantially equivalent to legally marketed predicate devices.

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Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue® Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

HemoCue® Glucose 201 System

I am sorry, but the provided text from the FDA 510(k) summary for the HemoCue® Glucose 201 System does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and study proving device performance.

Specifically, this document is a letter from the FDA acknowledging the substantial equivalence of the device and its indications for use. It's a regulatory approval document, not the scientific study report itself.

Here's what I can and cannot provide based on the given text:

Information I CANNOT provide from this document:

• A table of acceptance criteria and the reported device performance: This detailed data is not present.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and this type of study is typically for imaging devices, not glucose meters.
• If a standalone study was done: While the FDA review implies performance data was submitted, the details of such a study (standalone or otherwise) are not in this letter.
• The type of ground truth used: Not specified in this document. For a glucose meter, this would typically involve a laboratory reference method.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Information I CAN provide based on the given text:

• Device Name: HemoCue® Glucose 201 System
• Regulation Number/Name: 21 CFR 862.1345, Glucose test system
• Regulatory Class: Class II

To answer your request completely, I would need access to the actual HemoCue® Glucose 201 System's 510(k) submission summary or the underlying study reports, which are not provided in the text.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device