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510(k) Data Aggregation
(32 days)
ACE® Carbamazepine Reagent is intended for use in the quantitative determination of carbamazepine in human serum.
ACE® Carbamazepine Reagent is intended for the quantitative determination of carbamazepine in serum using the ACE® clinical chemistry analyzer.
The ACE® Carbamazepine Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to carbamazepine and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites . In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The ACE® Carbamazepine Reagent is an enzyme immunoassay intended for the quantitative determination of carbamazepine in human serum.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K955100) | Reported Device Performance (ACE® Carbamazepine Reagent) |
|---|---|---|
| Assay Range | 0.5 µg/mL to 20 µg/mL | 0.3 µg/mL to 20 µg/mL |
| Precision | ||
| Within Run | <3.1 %CV | <4.7 %CV |
| Between Run | <8.2 %CV | <8.2 %CV |
| Correlation vs. | Commercial Carbamazepine assay | Hitachi 717 |
| Slope | 0.91 | 0.947 |
| Intercept | -0.1 | 0.21 |
| r (correlation) | 0.970 | 0.986 |
| N (sample size) | 99 | 48 |
Note: The document implies the predicate device's performance serves as the de-facto acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation Study:
- For the comparison with the commercial carbamazepine assay (predicate device), the sample size was N=99.
- For the comparison with the Hitachi 717, the sample size was N=48.
- Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "Non-clinical test results submitted..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) for quantifiable analytes (carbamazepine concentration). Ground truth is established by a reference method or validated analyzer, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD device study. Ground truth is determined by quantitative measurements against a recognized method or instrument, not through human adjudication of qualitative findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This is not applicable for an IVD device measuring a chemical analyte. MRMC studies are typically used for medical imaging devices where human interpretation plays a significant role.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance assessment described is a standalone performance of the ACE® Carbamazepine Reagent. It evaluates the device's accuracy, precision, and correlation with other methods, without human intervention in the measurement process. The device itself is designed to provide a quantitative result.
7. The Type of Ground Truth Used
The ground truth was established by comparison to:
- A "Commercial Carbamazepine assay" (for the predicate device comparison).
- A "Hitachi 717" analyzer (for the proposed device's correlation study).
These are established laboratory methods/instruments used for measuring carbamazepine concentrations, serving as the reference standard or "ground truth" for quantitative accuracy.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. For an IVD reagent kit, training data often refers to internal development and validation data, which is typically not detailed in a 510(k) summary in this manner. The reported data pertains to the performance evaluation/test set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" with established ground truth in the context of machine learning is not described or relevant for this type of chemical reagent 510(k) submission. The performance assessment describes the device's capabilities against existing, accepted quantitative methods.
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