(14 days)
The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic urinary assays for detection of D-Amphetamine (AMP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1000 ng AMP/ml. These tests are intended for visual, qualitative IVD screening, and professional use only, and are not intended for quantitative results, nor for over the counter use. These screen tests for Amphetamine, analogs and metabolites provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA recommend gas chromatography/mass spectrometry (GCMS) as the preferred confirmed analytical method. Clinical Considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (i.e., LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays in which a chemically labeled drug conjugate competes with Amphetamine (AMP) drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Amphetamine devices contain a unique membrane that has been pre-coated both with AMP drug conjugate at the test band, and have a built-in reference band with second antibody as a system control band. A pink colored anti-AMP monoclonal antibody-colloidal gold conjugate pad is placed on the test strip. In the absence of AMP drug, analogs or metabolites in the test urine, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the capillary action. The antibody-colloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex. This complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When AMP is present in a test urine, that drug, analog or metabolite antigen competes with AMP conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of urinary AMP drug, analogs or metabolites is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Amphetamine drug conjugate zone located at the LiveSure™ Amphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of AMP in samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip:
Acceptance Criteria and Device Performance Study
The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays for the detection of D-Amphetamine (AMP) in human urine. The study presented aims to demonstrate the substantial equivalence of these devices to a predicate device (EMIT® II Assay) and their performance against a gold standard (GC/MS).
1. Table of Acceptance Criteria and Reported Device Performance
While explicit acceptance criteria (e.g., "must achieve X% sensitivity") are not directly stated, the summary outlines performance comparisons to establish equivalency and superiority against a predicate device and a gold standard. The criteria are implicitly tied to achieving high agreement with the gold standard (GC/MS) and demonstrating comparable or better performance than the predicate (EMIT® II Assay).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (LiveSure™ Amphetamine Tests) | Reported Performance (EMIT® II Assay) |
|---|---|---|---|
| Agreement with GC/MS (quantitative positive results) | 100% agreement with positive GC/MS results | 100% | (Not explicitly stated for EMIT® II) |
| Agreement with GC/MS (negative results) | High agreement with negative GC/MS results (e.g., >95%) | 98.8% | 97.6% |
| Agreement with EMIT® II (positives) | High agreement with positive results of predicate device (e.g., >95%) | 98.0% | - |
| Specificity vs EMIT® II (negatives) | High specificity vs negative results of predicate device (e.g., >95%) | 100% | - |
| False Positives (vs GC/MS below 750 ng/ml) | No false positives | 0 FP (for urine samples with GC/MS results below 750 ng/ml) | 1 FP |
| Overall Accuracy (vs GC/MS) | High overall accuracy (e.g., >95%) | 255/257 (99.2%) | 253/255 (98.4%) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 257 urine samples were used for the independent clinical testing.
- Data Provenance: The study was conducted as "independent clinical testing" at an "external reference laboratory." The source of the urine samples (e.g., country of origin, demographics) is not specified. The study appears to be retrospective, as urine samples were tested against the LiveSure™ devices and the EMIT® II Assay, and then compared to GC/MS results, implying existing samples.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly mention the number or qualifications of experts used to establish the ground truth. However, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly reliable and recognized analytical method in clinical and forensic toxicology. The process for generating GC/MS results would typically involve laboratory technicians or chemists, but the decision on what constitutes a "positive" or "negative" result would be based on established NIDA/SAMHSA cut-off levels (1000 ng AMP/ml).
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison is directly between the results of the LiveSure™ devices, the EMIT® II Assay, and the GC/MS ground truth. Since the devices provide qualitative results (presence/absence of a band) and GC/MS provides quantitative results which are then interpreted against a cut-off, it's unlikely an adjudication method for interpretations was used in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The devices are described as "rapid qualitative chromatographic immunoassays" intended for "visual, qualitative (VD) screening." The output is a visual pink colored band or lack thereof, which implies a direct reading rather than complex human interpretation that would necessitate an MRMC study to assess human-in-the-loop performance or improvement with AI assistance. This is an immunoassay, not an AI-assisted diagnostic.
6. Standalone Performance
Yes, a standalone performance evaluation was conducted for the LiveSure™ Amphetamine Tests. The devices were tested independently against urine samples, and their results were compared to the GC/MS ground truth and the predicate EMIT® II Assay. The reported performance metrics (e.g., 99.2% overall accuracy vs GC/MS) reflect the standalone performance of the device without human interpretation variability being a primary focus.
7. Type of Ground Truth Used
The primary ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry) quantitative results. This method is explicitly identified as the "preferred confirmed analytical method" by NIDA and SAMHSA.
8. Sample Size for the Training Set
The document does not provide any information about a separate training set or its sample size. The description focuses on a single "independent clinical testing" dataset of 257 samples. For these types of immunoassay devices, a distinct "training set" in the machine learning sense is typically not applicable, as the device operates based on chemical reactions rather than a trained algorithm. However, manufacturers would perform extensive in-house testing and development, which implicitly serves a similar purpose to "training" in refining the device's sensitivity and specificity.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is mentioned in the context of this submission, the method for establishing its ground truth is also not provided. The development and validation of such immunoassays typically involve extensive internal testing against characterized samples, with ground truth established through established analytical methods like GC/MS.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).