(339 days)
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.
| Acceptance Criteria (based on predicate device comparison) | Reported Device Performance (IMx® Glycated Hemoglobin II vs. Bio-Rad DIAMAT™) |
|---|---|
| Intended Use: Quantitative determination of glycated hemoglobin in human anticoagulated whole blood. | Both devices share the same intended use. |
| Analyte Measured: Glycated Hemoglobin (%A1c) | Both devices measure Glycated Hemoglobin, %A1c. The IMx device also reports %GHb. |
| Assay Principle: (Not a direct acceptance criterion, but part of comparison) | IMx uses Boronate affinity Ion Capture (Predicate uses Ion exchange liquid chromatography - HPLC). |
| Instrumentation: (Not a direct acceptance criterion, but part of comparison) | IMx uses IMx Analyzer (Predicate uses DIAMAT Analyzer System). |
| Standardization: Traceable to DCCT reference method; Certified via NGSP. | Both devices are traceable to DCCT and certified via NGSP. |
| Sample Type: Human anticoagulated whole blood. | Both devices use human anticoagulated whole blood (IMx: EDTA, lithium heparin, sodium heparin; Predicate: EDTA, potassium oxalate, sodium fluoride). |
| Correlation with Predicate Device (demonstrating substantial equivalence): | Regression Method: Least Squares |
| n: 247 | |
| r: 0.976 | |
| Slope: 0.94 | |
| Intercept: 0.45 | |
| Regression Method: Passing-Bablok | |
| n: 247 | |
| r: 0.976 | |
| Slope: 0.98 | |
| Intercept: 0.13 |
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.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).