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510(k) Data Aggregation
(64 days)
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of barbiturates in the human urine. Emit® II assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Barbiturate Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of barbiturates in human urine. The Emit® II Plus Barbiturate Assay has been found to be equivalent to the predicate device. Emit® II Barbiturate Assay, with regard to intended use, assay sample, and overall performance characteristics.
The provided text describes the Emit® II Plus Barbiturate Assay, an in vitro diagnostic device. The study described focuses on demonstrating equivalence to a predicate device rather than outright performance against a broad "acceptance criteria" in the way a novel AI device might. However, we can extract the performance characteristics and implicitly defined acceptance criteria from the information given.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Comparative Analysis | ||
| Agreement at 200 ng/mL cutoff (negative/positive) | High agreement with predicate device | 94% agreement with predicate method |
| Agreement at 300 ng/mL cutoff (negative/positive) | High agreement with predicate device | 100% agreement with predicate method |
| Spiked Sample Recovery (Qualitative Mode) | ||
| Correct identification of spiked specimens +25% of 200 ng/mL secobarbital as positive | 100% correct identification | Correctly identified as positive |
| Correct identification of spiked specimens +25% of 300 ng/mL secobarbital as positive | 100% correct identification | Correctly identified as positive |
| Spiked Sample Recovery (Semiquantitative Mode) | ||
| Recovery within range of nominal concentrations for 200-800 ng/mL secobarbital | Acceptable recovery (e.g., within a certain percentage) | 99%-114% of nominal concentrations |
| Precision (Qualitative Mode) | Acceptable within-run and total precision | |
| Within-run %CV (controls and cutoff rates) | Low %CV | 0.4 - 0.5% |
| Total %CV (controls and cutoff rates) | Low %CV | 0.6 - 0.7% |
| Precision (Semiquantitative Mode) | Acceptable within-run and total precision | |
| Within-run %CV (controls and cutoff concentrations) | Low %CV | 1.0 - 3.8% |
| Total %CV (controls and cutoff rates) | Low %CV | 1.9 - 4.2% |
| Sensitivity | Ability to distinguish from 0 ng/mL with confidence | Less than 20 ng/mL (at 95% confidence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for the comparative analysis or spiked sample recovery tests. It refers to "samples" and "specimens" without providing a count.
- Data Provenance: The document implies that the studies were conducted by Syva Company - Dade Behring Inc. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of in vitro diagnostic device studies for regulatory submission, it is typically prospective or involves well-defined banked samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable in the context of this device and study. The "ground truth" for a chemical assay like this is typically established by reference methods (e.g., the predicate device or GC/MS), not by human experts.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods (like 2+1, 3+1) are common in image interpretation studies where human expert disagreement needs to be resolved. For an immunoassay, the "adjudication" would be a comparison to the reference method (predicate device or GC/MS), which is a direct measurement or established analytical result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI). The Emit® II Plus Barbiturate Assay is an automated chemical assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this entire study describes the standalone performance of the assay. There is no "human-in-the-loop" component for interpretation; the device provides a direct analytical result.
7. The Type of Ground Truth Used
- Comparative Analysis: The "ground truth" was the result obtained from the predicate device, the Emit® II Barbiturate Assay.
- Spiked Sample Recovery: The "ground truth" was the known concentration of secobarbital spiked into negative human urine specimens.
- Sensitivity: The "ground truth" was the known concentration of secobarbital from 0 ng/mL upwards.
8. The Sample Size for the Training Set
- This information is not applicable. This is an immunoassay, not a machine learning or AI device that requires a training set. The assay's performance is based on its chemical reagents and detection system, developed through traditional chemical and biological engineering, not trained on data in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" in the context of this immunoassay.
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