(194 days)
Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.
Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 barbiturate use or abuse. The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the addition of a surfactant to the diluent. 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 the study details for the Abuscreen ONLINE® Barbiturates device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Proposed Device) | Reported Device Performance (Predicate Device) |
|---|---|---|
| Precision Qualitative (200 ng/mL Cutoff): | ||
| >95% negative at 150 ng/mL | >95% negative at 150 ng/mL | >95% negative at 160 ng/mL |
| >95% positive at 250 ng/mL | >95% positive at 250 ng/mL | >95% positive at 240 ng/mLL |
| Within Run Precision (Qualitative): | ||
| 100 ng/mL | Mean (OD): 3538, CV%: 2.4 | Not specified |
| 150 ng/mL | Mean (OD): 3027, CV%: 2.1 | Not specified |
| 200 ng/mL | Mean (OD): 2427, CV%: 2.0 | Not specified |
| 250 ng/mL | Mean (OD): 2138, CV%: 1.9 | Not specified |
| 300 ng/mL | Mean (OD): 1926, CV%: 1.5 | Not specified |
| Day-to-Day Precision (Qualitative): | ||
| 100 ng/mL | Mean (OD): 3602, CV%: 3.3 | Not specified |
| 150 ng/mL | Mean (OD): 3134, CV%: 3.7 | Not specified |
| 200 ng/mL | Mean (OD): 2498, CV%: 4.1 | Not specified |
| 250 ng/mL | Mean (OD): 2210, CV%: 4.1 | Not specified |
| 300 ng/mL | Mean (OD): 1992, CV%: 3.7 | Not specified |
| Precision Quantitative (200 ng/mL): | ||
| Within Run (Quantitative): | ||
| 100 ng/mL | Mean (ng/mL): 97, CV%: 3.9 | Mean (ng/mL): 105, CV%: 3.7 |
| 150 ng/mL | Mean (ng/mL): 144, CV%: 3.0 | Mean (ng/mL): 163, CV%: 2.5 |
| 200 ng/mL | Mean (ng/mL): 207, CV%: 2.8 | Mean (ng/mL): 194, CV%: 1.5 |
| 250 ng/mL | Mean (ng/mL): 275, CV%: 1.5 | Mean (ng/mL): 221, CV%: 1.8 |
| 300 ng/mL | Mean (ng/mL): 311, CV%: 1.2 | Mean (ng/mL): 289, CV%: 0.8 |
| Day-to-Day (Quantitative): | ||
| 100 ng/mL | Mean (ng/mL): 98, CV%: 3.6 | Mean (ng/mL): 110, CV%: 5.5 |
| 150 ng/mL | Mean (ng/mL): 144, CV%: 3.3 | Mean (ng/mL): 169, CV%: 3.4 |
| 200 ng/mL | Mean (ng/mL): 203, CV%: 2.8 | Mean (ng/mL): 201, CV%: 2.6 |
| 250 ng/mL | Mean (ng/mL): 270, CV%: 2.6 | Mean (ng/mL): 229, CV%: 2.6 |
| 300 ng/mL | Mean (ng/mL): 309, CV%: 2.2 | Mean (ng/mL): 294, CV%: 4.2 |
| Accuracy (200 ng/mL Cutoff): | 50 samples were confirmed positive, all 50 tested positive (0 negative). | 74 samples were confirmed positive, all 74 tested positive (0 negative). |
| Limit of Detection: | 2 ng/mL | 20 ng/mL |
Study Information:
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Sample size used for the test set and the data provenance:
- Accuracy Test Set: N=50 for the proposed device (confirmed positively for barbiturates).
- Accuracy Test Set (Predicate): N=74 for the predicate device (confirmed positively for barbiturates).
- Precision Test Set: The number of runs/replicates for the precision studies (within-run and day-to-day for both qualitative and quantitative) is not explicitly stated in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The term "Confirmed Pos." is used for accuracy, implying a reference method was used to establish ground truth, but who performed it or their qualifications are not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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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. This device is an in vitro diagnostic (IVD) immunoassay for detecting barbiturates in urine. It's a laboratory test, not an AI-assisted diagnostic imaging tool that would involve human readers. Therefore, an MRMC study or AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This refers to the performance of the device itself (the immunoassay on the Hitachi 917 analyzer). The data presented in "Table 3" (Proposed column) is the standalone performance of the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For accuracy, the ground truth was established by "Confirmed Pos." This strongly suggests a confirmatory analytical method (e.g., GC/MS) for the presence of barbiturates, rather than expert clinical consensus or pathology, as is common for drug screening tests.
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The sample size for the training set:
- This information is not provided as this is an immunoassay kit (chemical reagents and method), not a machine learning algorithm that requires a "training set" in the traditional sense. The development of such assays involves formulation, calibration, and optimization, not a data-driven training process.
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How the ground truth for the training set was established:
- Not applicable, as there isn't a "training set" in the context of an immunoassay kit for machine learning. The "ground truth" for calibrators would be established through precise analytical methods to create known concentrations.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).