(64 days)
The Emit® II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Methaqualone 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. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Syva Emit® II Plus Methaqualone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methaqualone in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Based on the provided 510(k) summary, the device is an in-vitro diagnostic assay, not an AI device or one that involves human interpretation in the way the questions usually imply (e.g., radiologists interpreting images). Therefore, many of the requested fields (like number of experts, adjudication methods, MRMC studies) are not applicable in this context. The acceptance criteria and performance are focused on the analytical performance of the assay itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Comparative Analysis (Qualitative) | Substantial equivalence to predicate device; high agreement in finding specimens negative and positive. (Implied for substantial equivalence) | 98% agreement with the predicate device in finding specimens negative and positive. |
| Spiked-Sample Recovery (Qualitative) | Correct identification of spiked specimens relative to the 300 ng/mL cutoff. Should consistently distinguish negative/positive for certain ranges around cutoff. | Correctly identified spiked specimens 300 ng/mL as positive. Consistently distinguished as negative or positive for levels ≤ 25% below cutoff (0-225 ng/mL) and ≥ 25% above cutoff (375-3000 ng/mL). |
| Spiked-Sample Recovery (Semiquantitative) | Recovery within 15% of nominal concentrations for spiked analytes within the semiquantitative range. | Within the semiquantitative range of 150 to 900 ng/mL, recovery was within 15% of the nominal concentrations of spiked analyte. |
| Precision (Qualitative Rate) | Acceptable within-run and total precision statistics, Coefficients of Variation (CV) (Implied). | Within-run precision CV: 0.4% to 0.5%. Total precision CV: 0.5% to 0.7%. |
| Precision (Semiquantitative Concentration) | Acceptable within-run and total precision statistics, Coefficients of Variation (CV) (Implied). | Within-run CV: 0.9% to 1.0%. Total precision CV: 1.2% to 1.7%. |
| Sensitivity | Ability to distinguish lowest concentration from 0 ng/mL with 95% confidence. (Implied) | Sensitivity less than 43 ng/mL (represents the lowest concentration of methaqualone that can be distinguished from 0 ng/mL with a confidence level of 95%). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Comparative Analysis: Not explicitly stated how many specimens were used, but the summary refers to "specimens" from which 98% agreement was observed.
- Sample Size for Spiked-Sample Recovery: "Negative human urine" was spiked, but the number of unique samples or total tests is not specified.
- Sample Size for Precision: Controls and cutoff calibrator were used, but the specific number of runs or repetitions is not specified.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective laboratory studies conducted by the manufacturer, rather than retrospective analysis of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an in-vitro diagnostic assay. The "ground truth" for the test set is established by the known concentrations of methaqualone in spiked samples or by the results of a predicate method, not by human expert interpretation.
4. Adjudication Method for the Test Set
N/A. Adjudication is not applicable as this involves quantitative and qualitative chemical analysis, which relies on objective measurements rather than subjective human interpretation needing consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not applicable to an in-vitro diagnostic assay that performs chemical analysis. It's typically used for imaging or diagnostic aids that involve human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The studies described (comparative analysis, spiked-sample recovery, precision, sensitivity) assess the performance of the assay itself as a standalone diagnostic tool, without human intervention in the result generation or interpretation to improve its core output. The assay produces a direct qualitative (positive/negative) or semiquantitative result. The "human-in-the-loop" aspect for such devices typically refers to the clinician's overall judgment in interpreting the test result in the context of a patient's condition, which is a broader clinical practice rather than an integral part of the device's performance study for regulatory approval.
7. The Type of Ground Truth Used
- Comparative Analysis: The results from the predicate device (Syva Emit® II Methaqualone Assay) served as the reference or "ground truth" for comparison.
- Spiked-Sample Recovery: The known, pre-determined concentrations of methaqualone spiked into negative human urine served as the ground truth.
- Precision: Internal controls and calibrators with known values were used.
- Sensitivity: Established by statistical methods comparing assay response to 0 ng/mL.
8. The Sample Size for the Training Set
N/A for this type of device. There isn't a "training set" in the context of machine learning or AI. The assay's chemical formulation and parameters are developed through laboratory optimization processes, not through training on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
N/A. See explanation in point 8.
§ 862.3630 Methaqualone test system.
(a)
Identification. A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.(b)
Classification. Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).