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The Abbott IMx® Glycated Hemoglobin II assay is an Ion Capture Assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used in the management of diabetes mellitus.

The Abbott IMx Glycated Hemoglobin II assay is a boronate affinity binding assay using Ion Capture separation for the quantitative determination of percent glycated-hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin) on the Abbott IMx analyzer. Glycated hemoglobin measurements are used in the management of diabetes mellitus. The Abbott IMx Glycated Hemoglobin II assay is calibrated with Abbott IMx Glycated Hemoglobin II Calibrators. Abbott IMx Glycated Hemoglobin II Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.

This document describes the acceptance criteria and study proving the Abbott IMx® Glycated Hemoglobin II device meets those criteria, based on the provided 510(k) summary (K992085).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abbott IMx® Glycated Hemoglobin II assay is demonstrating substantial equivalence to the predicate device, the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System. This was assessed through a correlation study.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: 247
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of study for a Glycated Hemoglobin assay typically relies on comparison to a reference or predicate method, not expert interpretation of results. Therefore, the concept of "experts establishing ground truth" in the diagnostic imaging sense does not directly apply here. The "ground truth" for the comparison is the result obtained from the predicate device (Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System), which is itself a validated diagnostic assay.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the study compared results to a predicate device, not through an adjudication process of subjective interpretations.

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. This is a diagnostic assay, not an AI-assisted diagnostic imaging device with human readers.

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

Yes, the study is a standalone performance assessment of the Abbott IMx® Glycated Hemoglobin II assay in comparison to the predicate device. The assay performs its measurement and provides a result without human interpretation of raw data in the sense of an imaging study.

7. The Type of Ground Truth Used

The "ground truth" for the correlation study was the quantitative results generated by the predicate device, the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System. This is a form of comparison to an established and legally marketed diagnostic device. The predicate device itself is standardized and certified via the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT) reference method.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. In the context of an in-vitro diagnostic assay validation, the focus is typically on the performance of the final assay against established methods rather than an iterative machine learning training process.

9. How the Ground Truth for the Training Set was Established

Not applicable, as a distinct "training set" and its associated ground truth establishment methods are not described in this 510(k) summary for this type of device. The assay's method is based on established chemical principles (boronate affinity binding) rather than statistical learning from a large training dataset.

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The Precision A1c Home HbA1c Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbA1c (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus.

The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

The Precision A1c Home HbA1c Sample Collection Kit contains the materials necessary to collect a capillary blood sample from a finger-stick to a piece of filter paper and mail it to a clinical laboratory for the determination of percent hemoglobin A1c (also known as glycohemoglobin or glycosylated hemoglobin).

The Precision A1c sample collection kit contains a lancet, patient information sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for Precision A1c™ Home HbA1c Sample Collection Kit (K983253)

The key performance criteria for the Precision A1c™ Home HbA1c Sample Collection Kit are based on the correlation and agreement of HbA1c results obtained from samples collected with the kit compared to whole blood samples. The study assessed the performance of the device when used by both trained operators and lay users.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values (e.g., "correlation coefficient must be > 0.95"). However, the language of the conclusion, stating "Results indicate excellent correlation... and equivalent results," strongly implies that the observed performance values were considered acceptable. Based on the data presented and the concluding remarks, the implied acceptance criteria would generally be a correlation coefficient close to 1.000, a slope close to 1.000, and a y-intercept close to 0.0, along with low bias and Sy.x values.

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