(55 days)
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.
The provided text (K023048) is a 510(k) summary for the SYNCHRON Systems Benzodiazepine Reagent. It outlines the device's intended use, its relationship to a predicate device, and generally states that "Performance data from validation testing supports equivalency."
However, the provided document does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in a quantitative manner. It's a regulatory summary, not a technical performance report. Therefore, I cannot fully complete all sections of your request based solely on the provided text.
Here's what I can extract and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL. | "Performance data from validation testing supports equivalency." (No specific metrics like sensitivity, specificity, accuracy, or concordance are provided in this summary.) |
| Equivalent performance to the predicate device (SYNCHRON Systems Benzodiazepine Reagent K944076). | "Performance data from validation testing supports equivalency." (No detailed comparison results are given.) |
| The assay provides a rapid screening procedure. | Implied by the nature of the device, but no quantitative measure of "rapid" is provided. |
| Preliminary analytical result, requiring confirmation by non-immunological methods (TLC, GC, GC/MS). | The device description specifies this as part of its intended use, indicating it meets this functional characteristic. |
| Modified antibody for drug cross-reactivity provides equivalent or improved performance. | The summary states "The SYNCHRON Systems Benzodiazepine reagent antibody has been modified for drug cross-reactivity," and performance supports equivalency. However, no specific cross-reactivity data or comparison is provided. |
Study Details (Based on available information in the 510(k) summary)
-
Sample size used for the test set and the data provenance:
This information is not provided in the 510(k) summary. The document only states "Performance data from validation testing supports equivalency" without detailing the nature, size, or origin of the samples used in that testing. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The device is an in vitro diagnostic device that measures a chemical compound. Ground truth for such devices is typically established through a reference method (like GC/MS), not usually by expert human consensus in the same way an image analysis algorithm might be. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. Adjudication by multiple experts is typically used for subjective assessments (e.g., in medical imaging). For a quantitative chemical assay, the "ground truth" is typically established by an independent, highly accurate reference method (e.g., GC/MS), rather than human 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:
This is not applicable. This device is a reagent for an automated in vitro diagnostic system, not an AI or imaging device designed to assist human readers in interpretation. There are no "human readers" in the context of this device's primary function; it provides a direct qualitative result. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, implicitly. As an in vitro diagnostic reagent run on an automated system (SYNCHRON Systems), its performance is inherently "standalone" in terms of generating the qualitative result. The "human-in-the-loop" aspect comes after the preliminary result, where a clinician applies judgment and, if positive, orders confirmatory tests. The performance data would relate to the accuracy of the reagent/system itself. However, the details of such a standalone study (e.g., sensitivity, specificity, accuracy against a gold standard) are not provided in this summary. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the preferred confirmatory method is stated as GC/MS (gas chromatography/mass spectrometry). This would be the "gold standard" or "ground truth" against which the device's performance would be compared. -
The sample size for the training set:
This information is not provided. The summary mentions the antibody was "modified," implying development and potentially "training" or optimization, but no details on training data size are given. -
How the ground truth for the training set was established:
This information is not provided. However, it would logically be established using a similar approach to the test set ground truth, most likely using a reference method like GC/MS.
In summary: The 510(k) summary provides the regulatory context and intended use but lacks the detailed performance metrics and study design specifics you've requested. This level of detail is typically found in the full 510(k) submission document or supporting technical reports, not usually in the summary itself.
§ 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).