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510(k) Data Aggregation
(64 days)
BAYER HEALTHCARE, DIAGNOSTICS DIVISION
The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnosic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma (lithium heparin), and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
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Acceptance Criteria and Study for Bayer ADVIA® 1650 Glucose Assays
This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Bayer ADVIA® 1650 Glucose Hexokinase II and Glucose Oxidase assays.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria with specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the performance is evaluated through imprecision and method correlation studies against a legally marketed predicate device (Roche Glucose Hexokinase). The "acceptance criteria" can be inferred from the successful outcome of these studies, demonstrating comparable performance to the predicate.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (ADVIA® 1650 Glucose Oxidase) | Reported Device Performance (ADVIA® 1650 Glucose Hexokinase II) |
|---|---|---|---|
| Imprecision (Within-run CV%) | Comparable to Roche Glucose Hexokinase (e.g., ≤ 1.8% at similar levels) | ||
| - Level 1 | ≤ 1.6% (Roche at 31 mg/dL) | 1% (at 58.0 mg/dL) | 1.2% (at 60.2 mg/dL) |
| - Level 2 | ≤ 1.8% (Roche at 59 mg/dL) | 1.1% (at 34.2 mg/dL) | 1.7% (at 36.9 mg/dL) |
| Method Correlation | Strong correlation with predicate device (high r-value, regression close to Y=X) | ||
| - Regression Equation | (Implicitly close to Y=X) | $Y = 0.97x + 4.47$ | $Y = 1.03x - 1.25$ |
| - Syx (Standard Error of Y on X) | (Implicitly low) | 7.6 | 6.4 |
| - Correlation Coefficient (r) | (Implicitly high, e.g., > 0.95) | 0.994 | 0.987 |
| Analytical Range | Sufficient for intended use | 0-750 mg/dL | 0-700 mg/dL |
2. Sample Size and Data Provenance for Test Set
- Glucose Oxidase:
- Sample Size: N = 56
- Data Provenance: Not explicitly stated, but the comparison is made against a "Roche (On Integra)" system, implying clinical samples were tested on both systems. The document does not specify the country of origin, nor whether the samples were retrospective or prospective.
- Glucose Hexokinase:
- Sample Size: N = 55
- Data Provenance: Not explicitly stated, but the comparison is made against a "Roche (On Integra)" system, implying clinical samples were tested on both systems. The document does not specify the country of origin, nor whether the samples were retrospective or prospective.
- Imprecision Study:
- The sample sizes for the imprecision study are not explicitly stated as 'N' for each level, but typical laboratory imprecision studies involve multiple replicates (e.g., 20 or more) over several days for each level. The reported "Within-run CV(%)" suggests a specific set of measurements, but the exact number of samples or runs is not detailed.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a diagnostic assay for quantitative determination of glucose. The "ground truth" is established by the reference measurement on the predicate device itself, which is a chemical analyzer. No human experts are involved in establishing the "ground truth" for the test results.
4. Adjudication Method for the Test Set
Not applicable. Since the device performs a quantitative chemical analysis, the direct output of the instrument (glucose concentration) is used for comparison. There is no qualitative assessment or interpretation by observers requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging device or a subjective interpretation device where human readers are involved. It is a quantitative chemical analyzer. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. Standalone Performance Study
Yes, standalone performance was done. The studies (imprecision and method correlation) directly assess the performance of the Bayer ADVIA® 1650 Glucose assays in isolation, by comparing its results to a predicate device. This is inherently a standalone performance evaluation of the algorithm/assay without human intervention in the result determination.
7. Type of Ground Truth Used
The ground truth for the method correlation studies was established by measurement on a legally marketed predicate device (Roche Glucose Hexokinase on an Integra system). For the imprecision study, the "ground truth" for the mean glucose level was the determined mean value from the measurements themselves, evaluated against the variability of those measurements.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or "training set sample size." This is typical for a traditional in vitro diagnostic device like a glucose assay evaluated through method comparison and imprecision studies. These types of devices do not typically undergo a development process involving distinct "training" and "test" sets in the way AI/Machine Learning models do. The performance characteristics are derived from direct analytical testing.
9. How Ground Truth for the Training Set was Established
Not applicable, as a distinct training set (in the context of AI/machine learning) is not described or implied for this type of medical device submission. The analytical performance is characterized through direct experimental measurement.
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(49 days)
BAYER HEALTHCARE, DIAGNOSTICS DIVISION
The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.
The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration.
The provided text is a 510(k) Summary for the Bayer Healthcare CO2 Calibrator/Diluent, which is a diagnostic device used to calibrate CO2 measurements. The nature of this device means that the "acceptance criteria" and "study" described are focused on its performance as a calibrator, primarily its stability and similarity to a predicate device, rather than a clinical study evaluating diagnostic accuracy in patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" or a direct study comparing the device against such criteria in the way one might expect for a diagnostic or imaging algorithm. Instead, it focuses on demonstrating that the device's performance is "similar to other products in commercial distribution intended for similar use" and that its stability meets Bayer's internal procedures.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Stability of CO2 Calibrator/Diluent value | Validated according to Bayer procedures based on results of three separate lots. Stable at 2-8°C until expiration date. Stable for 2 days when opened, reconstituted, stoppered, protected from light, and stored at 2-8°C (similar to predicate's 30-day post-reconstitution stability, but for a different format). |
| Performance vs. Predicate Device | "The performance of the calibrator is similar to other products in commercial distribution intended for similar use." (Comparison to Roche Diagnostics Corp. Calibrator for automated systems, K990460). |
| Intended Use | Meets the specified intended use: "to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments." |
| Format | Aqueous liquid solution containing bicarbonate at a defined concentration (differs from predicate's lyophilized pooled human serum). |
| Level | Single level (matches predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The stability validation was based on "three separate lots of calibrator material." This refers to manufacturing lots, not patient samples or a traditional 'test set' for diagnostic accuracy.
- Data Provenance: The data comes from internal validation procedures conducted by Bayer Healthcare Diagnostics Division. No mention of geographical origin (country) or retrospective/prospective nature other than it being an internal validation of product lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This type of device (a calibrator) does not involve expert interpretation or ground truth establishment in the manner of diagnostic image analysis or clinical data. Its "truth" is its certified concentration and stability, which would be determined through analytical chemistry methods and quality control, not expert consensus.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are used for reconciling differences in expert opinions, which is not applicable to a calibrator device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating human reader performance with medical images or clinical data, often with and without AI assistance. This calibrator device does not involve human readers interpreting clinical cases, nor does it involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. This device is a chemical calibrator, not an algorithm. Its performance is inherent to its chemical composition and manufacturing quality.
7. The Type of Ground Truth Used
The "ground truth" for this device would be the analytically verified concentration of bicarbonate and its stability over time and under specified conditions. This is established through accredited laboratory methods and quality control, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
N/A. This device is a calibrator, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, this question is not applicable.
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