(51 days)
Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse.
Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse.
The proposed Abuscreen ONLINE Amphetamines test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit.
The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.
Here's a breakdown of the acceptance criteria and study information for the Abuscreen ONLINE® Amphetamines device, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (from Predicate Device - K933052) | Reported Device Performance (Abuscreen ONLINE for Hitachi 917) |
|---|---|---|
| Precision Qualitative (1000 ng/mL Cutoff): | ||
| Negative at 800 ng/mL | >95% negative | >95% negative at 750 ng/mL (Exceeds predicate) |
| Positive at 1500 ng/mL | >95% positive | >95% positive at 1250 ng/mL (Exceeds predicate) |
| Quantitative Precision (Within Run): | CV% (Predicate): 3-6% | CV% (Proposed): 0.5-1.4% |
| Quantitative Precision (Day-to-Day): | CV% (Predicate): 4-7% | CV% (Proposed): 1.4-3.0% |
| Accuracy (1000 ng/mL Cutoff): | N=156 Confirmed Pos., 155 Pos., 1 Neg. | N=50 Confirmed Pos., 50 Pos., 0 Neg. |
| Limit of Detection | 30 ng/mL | 11 ng/mL (Exceeds predicate) |
Note: The document explicitly states, "The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device." The proposed device generally demonstrates equal or superior performance compared to the predicate.
Study Details
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Sample size used for the test set and the data provenance:
- Accuracy Test Set:
- Number of samples: N = 50 confirmed positive samples.
- Data provenance: Not explicitly stated, but assumed to be retrospective or prospective clinical samples given the context of "confirmed positive." No country of origin is mentioned.
- Accuracy Test Set:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The term "Confirmed Pos." suggests a definitive method for determining the true positive status, likely an orthogonal method like GC/MS (Gas Chromatography-Mass Spectrometry), which is common for drug screening confirmation, rather than expert consensus on images or clinical interpretation.
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Adjudication method for the test set:
- Not applicable/Not described. The ground truth (confirmed positive) would be established by an analytical method rather than a human adjudication process in this diagnostic context.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is an in vitro diagnostic for chemical analysis, not an imaging or interpretive device that would typically involve human readers or AI assistance in that manner.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics presented (Precision, Accuracy, LOD) are those of the device itself (reagent kit on the Hitachi 917 Analyzer), operating automatically without human interpretive input for the result generation. The device is intended for "qualitative and semiquantitative detection," which are objective measurements.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For Accuracy: "Confirmed Pos." (Confirmed Positive). This almost invariably refers to confirmation by a highly sensitive and specific analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS), which is considered the gold standard for drug confirmation testing.
- For Precision: Controlled samples with known concentrations (e.g., 500 ng/mL, 750 ng/mL, etc.) were used, making the true concentration the ground truth.
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The sample size for the training set:
- Not applicable/Not explicitly stated. This device is an immunoassay, not a machine learning or AI-driven system that would typically undergo a separate "training" phase with a distinct dataset in the modern sense. Its performance is based on the chemical reactivity of its components and its integration with the analyzer. Development and optimization would have occurred, but not in the "training set" paradigm of current AI.
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How the ground truth for the training set was established:
- Not applicable, as there's no explicit "training set" as understood in current AI/ML development. The "ground truth" for method development would involve preparing samples with known concentrations of drug metabolites and using reference methods (like GC/MS) to characterize unknown samples used during the development and validation of the assay's chemical and enzymatic reactions.
§ 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).