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510(k) Data Aggregation
(151 days)
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. The assay buffer is in dual aliquots, allowing for blanking and subtraction of potential interference effects.
Acceptance Criteria and Device Performance for Glucose Hexokinase II method for Bayer ADVIA® 1650 System (K011963)
This submission (K011963) is a 510(k) for a new version of a Glucose Hexokinase assay, called Glucose Hexokinase II, for the Bayer ADVIA® 1650 System. The submission claims substantial equivalence to the predicate device, also a Glucose Hexokinase assay (K991576). The "acceptance criteria" can be inferred from the reported performance of the predicate device, with the new device demonstrating comparable or improved performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds in this 510(k) summary. Instead, the sponsor demonstrates that the new device's performance characteristics (Imprecision, Correlation, Interfering Substances, Analytical Range) are comparable to, or improved relative to, those of the predicate device.
| Performance Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Glucose Hexokinase II) |
|---|---|---|
| Imprecision (Total CV%) | ||
| Serum (low) | 2.4% at 77 mg/dL | 2.2% at 75 mg/dL |
| Serum (high) | 3.3% at 279 mg/dL | 2.2% at 279 mg/dL |
| Urine (low) | 3.5% at 42 mg/dL | 4.1% at 46 mg/dL |
| Urine (high) | 3.6% at 285 mg/dL | 3.6% at 267 mg/dL |
| Correlation: Regression Equation (Y=new, X=predicate) | Close to Y=1.00x + 0.00 | |
| Serum | Y=1.02x-1.84 | Y=1.02x-1.84 |
| Urine | Y=0.97x-7.44 | Y=0.97x-7.44 |
| Plasma vs Serum* | Y=1.001x+0.088 | Y=1.001x+0.088 |
| Correlation: R-value | High (e.g., >0.99) | |
| Serum | 0.998 | 0.998 |
| Urine | 0.999 | 0.999 |
| Plasma vs Serum* | 0.9997 | 0.9997 |
| Correlation: Syx (mg/dL) | Low (e.g., <8 mg/dL) | |
| Serum | 7.49 | 7.49 |
| Urine | 5.68 | 5.68 |
| Plasma vs Serum* | 5.33 | 5.33 |
| Interfering Substances (Effect % change) | Minimized, ideally <10% | |
| Bilirubin (29.1 mg/dL) | 1.05% at 81.32 mg/dL glucose | 1.05% at 81.32 mg/dL glucose |
| Hemoglobin (522 mg/dL) | 0.78% at 80.6 mg/dL glucose | 0.78% at 80.6 mg/dL glucose |
| Lipids (Intralipid 630 mg/dL) | -4.7% at 80.2 mg/dL glucose | -4.7% at 80.2 mg/dL glucose |
| Analytical Range | 0 to 700 mg/dL (Serum/Plasma/Urine) | 0 to 700 mg/dL (Serum/Plasma/Urine) |
Note: The performance values for the "Reported Device Performance" are identical to the "Acceptance Criteria" because the submission presents the new device's performance directly and implicitly claims it meets the standard set by the predicate. The changes in the Glucose Hexokinase II assay are described as "improvements" due to the ability for blanking, which "eliminates interference effects," suggesting that the new device at least performs as well as, if not better than, the predicate in these areas.
2. Sample Size Used for the Test Set and Data Provenance
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Test Set Sample Sizes:
- Correlation (Serum): N = 194
- Correlation (Urine): N = 99
- Correlation (Plasma vs Serum): N = 35 (spiked samples used)
- Imprecision: Not explicitly stated as a single "test set" sample size but implied by the reported CVs for different levels in serum and urine. This typically involves running multiple replicates over several days.
- Interfering Substances: Not explicitly stated as individual sample sizes per substance, but implied to be sufficient for demonstrating the effect at the specified concentrations.
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Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a 510(k) submission for a diagnostic device, the studies are typically prospective clinical laboratory evaluations conducted under controlled conditions, often in the country where the manufacturer is seeking approval (USA in this case, for FDA approval).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This submission describes a laboratory assay for glucose measurement. The "ground truth" for such assays is typically established by comparing the device's measurements against a reference method or a carefully calibrated, validated existing method (such as the predicate device itself in correlation studies). There are no "experts" in the sense of clinical reviewers required to establish the ground truth for individual samples in this context. The accuracy of the "ground truth" (e.g., the predicate device's readings or reference method readings) is based on the inherent precision and accuracy of that reference method.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is a quantitative laboratory assay. The assessment involves direct comparison of numerical results, not subjective interpretation requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are relevant for medical imaging or subjective diagnostic interpretations where multiple human readers assess cases. This submission is for an automated laboratory diagnostic assay, not an imaging device or a device requiring human interpretation of complex visual data.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, this entire study is a standalone performance study. The Glucose Hexokinase II assay is an automated in vitro diagnostic procedure performed on the Bayer ADVIA® 1650 System. Its performance characteristics (imprecision, correlation, interference, analytical range) are evaluated inherently as an algorithm/system performance without human interpretation being a variable in the measurement process itself. Human involvement is limited to sample loading, system maintenance, and result review.
7. Type of Ground Truth Used
The ground truth for the performance studies is:
- For Imprecision: The mean glucose concentration of the control material or patient samples. The variability around this mean (CV%) indicates imprecision.
- For Correlation: The measurements obtained from the predicate device (ADVIA 1650 Glucose Hexokinase) are used as the comparative "ground truth" for the new device (ADVIA 1650 Glucose Hexokinase II). For plasma vs. serum correlation, the serum measurements from the ADVIA 1650 system are the reference.
- For Interfering Substances: The glucose concentration measured in the absence of the interfering substance, or the known spiking concentration, forms the basis for determining the "effect" of the interferent.
- For Analytical Range: The certified values of calibrators or spiked samples at the lower and upper limits of detection/linearity.
8. Sample Size for the Training Set
The document does not provide information about a "training set." This type of 510(k) submission for an in vitro diagnostic assay typically involves development and validation internally by the manufacturer, but the data presented here represents the validation studies to demonstrate substantial equivalence to an existing predicate. There isn't an "AI model" in the modern sense that needs a separate training set as it's a biochemical assay.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" for an AI model is not mentioned or relevant for this type of device. The development of the assay itself (e.g., optimizing reagent concentrations, reaction conditions) would have involved extensive R&D and internal testing using characterized samples and reference methods, which implicitly establishes "ground truth" during the development phase. However, these specific development details are not part of the 510(k) summary, which focuses on validation data against the predicate.
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