(113 days)
Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on the Hitachi 917 analyzer at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 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 benzodiazepine use or abuse.
The proposed Abuscreen ONLINE Benzodiazepines 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 Benzodiazepines test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an 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 study information for the Abuscreen ONLINE® Benzodiazepines device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document details various performance characteristics used to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicitly set by matching or surpassing the predicate's performance and demonstrating acceptable levels of precision and accuracy at different cut-off concentrations.
Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate K914509) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Qualitative Precision (100 ng/mL Cutoff) | ||
| % Negative at 80 ng/mL | >95% | >95% negative at 75 ng/mL |
| % Positive at 120 ng/mL | >95% | >95% positive at 125 ng/mL |
| Quantitative Precision (100 ng/mL Cutoff) - Within Run CV% | ||
| 50 ng/mL | 6.9% | 2.5% |
| 75 ng/mL | 3.6% | 1.9% |
| 100 ng/mL | 3.1% | 1.0% |
| 125 ng/mL | 2.9% | 1.3% |
| 150 ng/mL | 1.7% | 1.0% |
| Quantitative Precision (100 ng/mL Cutoff) - Day-to-Day CV% | ||
| 50 ng/mL | 10.1% | 3.2% |
| 75 ng/mL | 5.0% | 2.1% |
| 100 ng/mL | 4.1% | 1.7% |
| 125 ng/mL | 3.1% | 1.6% |
| 150 ng/mL | 2.7% | 1.5% |
| Qualitative Precision (200 ng/mL Cutoff) | Not explicitly stated for predicate in summary | >95% negative at 150 ng/mL |
95% positive at 250 ng/mL |
| Quantitative Precision (200 ng/mL Cutoff) - Within Run CV% | Not applicable for predicate | 100 ng/mL: 0.7%, 150 ng/mL: 1.3%, 200 ng/mL: 1.6%, 250 ng/mL: 1.8%, 300 ng/mL: 1.8% |
| Quantitative Precision (200 ng/mL Cutoff) - Day-to-Day CV% | Not applicable for predicate | 100 ng/mL: 2.7%, 150 ng/mL: 1.5%, 200 ng/mL: 1.5%, 250 ng/mL: 2.6%, 300 ng/mL: 3.1% |
| Qualitative Precision (300 ng/mL Cutoff) | Not explicitly stated for predicate in summary | >95% negative at 225 ng/mL
95% positive at 375 ng/mL |
| Quantitative Precision (300 ng/mL Cutoff) - Within Run CV% | Not applicable for predicate | 150 ng/mL: 1.7%, 225 ng/mL: 2.6%, 300 ng/mL: 1.9%, 375 ng/mL: 1.3%, 450 ng/mL: 1.2% |
| Quantitative Precision (300 ng/mL Cutoff) - Day-to-Day CV% | Not applicable for predicate | 150 ng/mL: 2.2%, 225 ng/mL: 2.7%, 300 ng/mL: 3.1%, 375 ng/mL: 2.9%, 450 ng/mL: 2.4% |
| Accuracy (100 ng/mL Cutoff) | N= 48 Confirmed Pos.
47 Pos. 1 Neg. | N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
N= 10 diluted within 25% above cutoff: 10 Pos. 0 Neg.
N= 10 diluted within 25% below cutoff: 0 Pos. 10 Neg. |
| Accuracy (200 ng/mL Cutoff) | Not applicable for predicate | N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
N= 10 diluted within 25% above cutoff: 10 Pos. 0 Neg.
N= 10 diluted within 25% below cutoff: 0 Pos. 10 Neg. |
| Accuracy (300 ng/mL Cutoff) | Not applicable for predicate | N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
N= 10 diluted within 25% above cutoff: 10 Pos. 0 Neg.
N= 10 diluted within 25% below cutoff: 0 Pos. 10 Neg. |
| Limit of Detection | 61 ng/mL (clinical sensitivity) | 100 Cutoff - 13 ng/mL
200 Cutoff - 16 ng/mL
300 Cutoff - 28 ng/mL |
Study Details
-
Sample size used for the test set and the data provenance:
- Precision Studies: The specific sample sizes for "Within Run" and "Day-to-Day" precision studies are provided in terms of replicates for different concentrations (e.g., 50 ng/mL, 75 ng/mL, etc.), but the total number of individual samples is not explicitly given. Each CV% calculation likely represents a set of replicates.
- Accuracy Studies:
- 100 ng/mL Cutoff: N=50 Confirmed Positive samples, N=10 samples diluted within 25% above cutoff, N=10 samples diluted within 25% below cutoff.
- 200 ng/mL Cutoff: N=50 Confirmed Positive samples, N=10 samples diluted within 25% above cutoff, N=10 samples diluted within 25% below cutoff.
- 300 ng/mL Cutoff: N=50 Confirmed Positive samples, N=10 samples diluted within 25% above cutoff, N=10 samples diluted within 25% below cutoff.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It describes the data as "clinical and nonclinical studies performed," which typically implies prospective data collection for performance evaluation of a new device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information about the number or qualifications of experts used to establish the ground truth. For drug screening tests, "confirmed positive" usually refers to confirmation by a highly sensitive and specific method like GC/MS (Gas Chromatography-Mass Spectrometry), which serves as the analytical ground truth. -
Adjudication method for the test set:
The document does not describe an adjudication method for the test set. For in vitro diagnostic tests, especially for drug screening, the "ground truth" is typically the result from a definitive confirmatory method (e.g., GC/MS), not subjective interpretation by human readers requiring adjudication. -
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers. It is an automated assay and does not involve human readers interpreting results in the way an imaging diagnostic device might. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, this entire submission is a standalone performance evaluation of the automated assay (the "algorithm only") on the Hitachi 917 Analyzer. The device itself is an in vitro diagnostic test, which by nature operates as a standalone system to detect analytes in a sample. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the accuracy studies, the ground truth is referred to as "Confirmed Pos." (Confirmed Positive), which in the context of drug screening tests typically means confirmation by a highly specific and sensitive analytical method such as Gas Chromatography-Mass Spectrometry (GC/MS). This is an analytical ground truth. -
The sample size for the training set:
The document does not explicitly state a "training set" sample size. For in vitro diagnostic devices like this, the development process involves reagent formulation and optimization that leverages proprietary internal data and methods, but it's not typically described in terms of a "training set" in the way machine learning algorithms are. The provided data focuses on the validation of the finalized assay. -
How the ground truth for the training set was established:
As no explicit "training set" is mentioned in the machine learning sense, the method for establishing its ground truth is not described. The analytical methods used to establish the reference values for calibrators and controls used during the development and validation of the assay would serve a similar purpose to ground truth in a broader sense.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).