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510(k) Data Aggregation
(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.
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(65 days)
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.
| Metric | Implied Acceptance Goal (Based on "excellent correlation" and "equivalent") | Trained Operator vs. Whole Blood | Lay User vs. Whole Blood | Trained Operator vs. Lay User |
|---|---|---|---|---|
| Correlation Coefficient | Close to 1.000 | 0.993 | 0.989 | 0.996 |
| Slope | Close to 1.000 | 1.019 | 1.016 | 0.999 |
| y-Intercept | Close to 0.0 | -0.02 | -0.05 | -0.04 |
| Sy.x | Low (e.g., < 0.3) | 0.22 | 0.27 | 0.18 |
| Bias | Low (e.g., close to 0.0) | 0.12 | 0.07 | -0.05 |
| Mean Absolute % Bias | Low (e.g., < 3%) | 2.50 | 2.77 | 1.76 |
| N (Sample Size) | Sufficient for statistical significance (minimum of 258/259 met) | 258 | 259 | 259 |
2. Sample Size for the Test Set and Data Provenance
- Sample Size:
- Trained Operator vs. Whole Blood: N = 258
- Lay User vs. Whole Blood: N = 259
- Trained Operator vs. Lay User: N = 259
- Data Provenance:
- The study involved clinical sites, and samples were collected from patients. However, the specific country of origin is not explicitly stated. The document refers to "LabOne" and "University of Missouri," suggesting the data is likely from the United States.
- The study appears to be prospective in nature, as it describes the collection of samples specifically for the performance evaluation from patients, followed by parallel analysis.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
The establishment of ground truth in this study relies on established laboratory instruments and methods rather than individual expert interpretation of complex images or clinical cases.
- Number of Experts: Not applicable in the traditional sense of medical imaging or diagnostic interpretation by human experts.
- Qualifications of Experts: The "ground truth" reference measurements were performed by laboratory instruments (Roche Cobas Integra, HbA1c Cassette; Roche Cobas Mira, Unimate Reagent; Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System) at clinical laboratories (LabOne and University of Missouri). These laboratories are assumed to be operating under standard clinical laboratory practices with qualified personnel.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by laboratory instrument readings, not by a consensus of human reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study is focused on the performance of a sample collection device, not on diagnostic accuracy of human readers with or without AI assistance. The comparison is between different sample collection methods and operators, with a reference to a laboratory analyzer.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The study evaluates the performance of the Precision A1c Home HbA1c Sample Collection Kit by comparing the results obtained using the kit (both by trained operators and lay users) against whole blood samples analyzed on predicate laboratory equipment. This demonstrates the performance of the device (the collection kit) in isolation of further human interpretation (beyond the initial sample collection).
7. Type of Ground Truth Used
The ground truth used was laboratory reference measurements from venous whole blood samples analyzed on established and previously cleared predicate HbA1c testing systems (Roche Cobas Integra, HbA1c Cassette; Roche Cobas Mira, Unimate Reagent; Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System). This represents an objective, quantitative measurement from a standard clinical method.
8. Sample Size for the Training Set
The document does not mention a training set. This is expected because the device is a sample collection kit and not a machine learning model that requires a training phase. The described study is a performance validation study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for this device.
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