Search Results
Found 1 results
510(k) Data Aggregation
(140 days)
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
The Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the following reasons (1-3):
- Serum phenobarbital concentrations correlate better with concentration in the brain than does dosage once steady state is reached.
- Patients taking the same dosage of phenobarbital show considerable variation in serum phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens.
Methods historically used to monitor serum phenobarbital concentrations are gas-liquid chromatography, high-performance liquid chromatography, radioimmunoassay, and immunoassay (1,2).
The Abbott Aeroset™ Phenobarbital Assay is a homogenous enzyme assay intended for use in quantitative analysis of phenobarbital in human serum or plasma.
Here's an analysis of the Abbott Aeroset Phenobarbital Assay based on the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Comparative Analysis: Equivalent to predicate device (Emit® 2000 Phenobarbital Assay (K913190)) | Correlation to predicate method resulted in a correlation of 1.00 with a slope value of 1.02. |
| Precision (Within-run): Acceptable coefficients of variation (%CV) | Ranged from 1.18% to 2.03% |
| Precision (Total): Acceptable coefficients of variation (%CV) | Ranged from 2.41% to 3.09% |
| Intended Use: Quantitative analysis of phenobarbital in human serum or plasma | The device is intended for this use and the performance metrics support it. |
| Assay Sample: Human serum or plasma | The device utilizes human serum or plasma. |
| Overall Performance Characteristics: Equivalent to predicate device. | The comparative analysis and precision studies demonstrate this equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set in the comparative analysis or precision studies. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for the test set. The evaluation is based on comparison to a predicate device and internal precision measurements.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there were no independent experts establishing ground truth. The comparison is made against the results from a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This device is an in-vitro diagnostic assay, not an imaging or diagnostic interpretation tool that would typically involve multiple human readers.
6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Was Done:
Yes, the studies described are standalone performance evaluations of the Abbott Aeroset Phenobarbital Assay itself. The "algorithm" here refers to the homogeneous enzyme immunoassay mechanism. The performance metrics (correlation, precision) are directly attributable to the device's function without human interpretation impacting the measurement results.
7. The Type of Ground Truth Used:
The primary "ground truth" used for performance evaluation is the predicate device's measurements (Emit® 2000 Phenobarbital Assay) and the inherent statistical properties of the assay itself (precision). For the comparative analysis, the ground truth is effectively the results obtained from the previously cleared Emit® 2000 Phenobarbital Assay.
8. The Sample Size for the Training Set:
The document does not specify a training set sample size. This type of in-vitro diagnostic assay is typically developed and optimized through validation studies, rather than "training" in the machine learning sense with a distinct training set. The reported studies are performance verification studies.
9. How the Ground Truth for the Training Set Was Established:
As there is no explicitly mentioned "training set" in the machine learning context, there is no description of how ground truth for such a set was established. Development and optimization of the assay would have involved standard analytical chemistry validation practices to ensure accuracy and reliability.
Ask a specific question about this device
Page 1 of 1