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510(k) Data Aggregation
(51 days)
ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.
ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.
Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.
The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone 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® Primidone Reagent is intended for the quantitative determination of primidone in human serum using the ACE® clinical chemistry analyzer. The device's performance was assessed by comparing it to a predicate device, the DRI Primidone Enzyme Immunoassay, and through non-clinical test results including within-run and between-run precision, and correlation against a Hitachi 717 analyzer.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" as pass/fail thresholds for precision or correlation. Instead, it presents the performance of the proposed device alongside the predicate device's performance for comparison, implying that performance comparable to or better than the predicate is acceptable.
| Parameter | Implied Acceptance Criterion (Compared to Predicate) | Proposed Device Performance | Predicate Device Performance |
|---|---|---|---|
| Assay Range | Comparable or wider range | 0.3 µg/mL to 24 µg/mL | 0.5 µg/mL to 24 µg/mL |
| Precision (Within Run) | Comparable or better (%CV) | < 3.5 %CV | < 7.9 %CV |
| Precision (Between Run) | Comparable or better (%CV) | < 7.0 %CV | < 5.6 %CV |
| Correlation (Slope) | Close to 1 (vs. Hitachi 717) | 0.998 | 0.92 (vs. Commercial Primidone assay) |
| Correlation (Intercept) | Close to 0 (vs. Hitachi 717) | -0.33 | 1.61 (vs. Commercial Primidone assay) |
| Correlation (r) | Close to 1 (vs. Hitachi 717) | 0.988 | 0.978 (vs. Commercial Primidone assay) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Correlation Test Set: N=50 samples were used for the correlation study of the proposed device against the Hitachi 717.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "Non-clinical test results submitted," suggesting internal laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a diagnostic reagent for quantitative determination, and its performance is evaluated against established analytical methods and instruments, not expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable for a quantitative diagnostic reagent. Ground truth is established through reference methods (like the Hitachi 717 analyzer) rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a diagnostic reagent, not an AI-powered image analysis or interpretation device. Therefore, MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (Assay Range, Precision, Correlation) represents the standalone performance of the ACE® Primidone Reagent when used on the ACE® clinical chemistry analyzer, without human interpretation as a primary output. Human involvement is limited to specimen handling and operating the instrument.
7. The Type of Ground Truth Used
- For Correlation: The "ground truth" for the proposed device's correlation study was established by comparing its results to those obtained from the Hitachi 717 analyzer. This represents an established, high-quality, quantitative reference method.
- For Precision: Precision (within-run and between-run) is an intrinsic measure of the device's reproducibility, not compared against an external "ground truth" in the same way as correlation.
- For Assay Range: The assay range is determined through analytical validation studies using known concentrations of primidone.
8. The Sample Size for the Training Set
Not applicable. This is a diagnostic reagent (enzyme immunoassay) and does not involve machine learning algorithms that require a "training set" in the conventional sense. Its performance relies on the biochemical interactions of its reagents.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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