(269 days)
The Psychemedics Microplate EIA For Benzodiazepines in Hair is an in vitro diagnostic device for the qualitative detection of benzodiazepines in hair. The assay is intended for use in workplace settings for the qualitative analysis of human head and body hair. The assay uses a cutoff calibrator of 1 ng oxazepam/10 mg hair.
The immunoassay consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Benzodiazepines. The screening portion of the test system consists of microplate wells coated with Oxazepam conjugated to bovine serum albumin (BSA), the prepared hair sample, a cutoff calibrator added to the sample at a concentration of 1 ng Oxazepam/10 mg hair, monoclonal mouse anti-Oxazepam antibody, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
The confirmation assay consists of a AB Sciex API 3200 LC/MS/MS (Serial numbers AA24661109 and AA28841310) linked to two Shimazu LC-20AD Micro pumps and a Leap Technologies PAL autosampler.
The provided text describes the performance characteristics of the "Psychemedics Microplate EIA for Benzodiazepines in Hair" (the "device") and its supporting studies. The information is presented in the context of a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for each performance metric in a pass/fail format. Instead, it describes validated ranges and outcomes that were considered acceptable for demonstrating the device's performance. The reported performance is directly from the tables and text provided.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Immunoassay Precision | Consistent positive/negative calls across concentrations and replicates, especially near the cutoff. | Intra-Assay: |
- Negative, 25%, 50%, 75% of cutoff: 15/0 (Negative/Positive)
- Cutoff: 7/8 (Negative/Positive)
- 125%, 150%, 175%, 200% of cutoff: 0/15 (Negative/Positive)
Inter-Assay: - Negative, 25%, 50%, 75% of cutoff: 75/0 (Negative/Positive)
- Cutoff: 43/32 (Negative/Positive)
- 125%, 150%, 175%, 200% of cutoff: 0/75 (Negative/Positive) |
| LC-MS/MS Precision | %CV of 10% or less for each level tested; concentrations within ± 15% of target; correlation coefficient >0.995; mean of replicates within ± 15% of predicted. | Alprazolam: %CV range 2.96% - 11.45% (n=5 samples, triplicate reps)
Lorazepam: %CV range 4.83% - 7.42% (n=4 samples, triplicate reps)
Diazepam: %CV range 0.91% - 12.77% (n=5 samples, triplicate reps)
Nordiazepam: %CV range 3.81% - 7.75% (n=4 samples, triplicate reps)
Oxazepam: %CV range 2.25% - 10.82% (n=4 samples, triplicate reps)
Temazepam: %CV range 1.99% - 13.12% (n=5 samples, triplicate reps) |
| LC-MS/MS Linearity | %CV ≤ 10%, concentrations within ± 15% of target, correlation coefficient >0.995, mean of replicates within ± 15% of predicted value based on linear regression. | All conditions met, establishing a linear range of 0.05 to 20.0 ng/10 mg hair for Alprazolam, Lorazepam, Diazepam, Nordiazepam, and Temazepam. |
| LC-MS/MS Detection Limit (LLOQ) | Analyte response at LLOQ ≥ 5 times blank response; identifiable, discrete, reproducible peak; precision (CV) ≤ 20%; accuracy within 20% of nominal. | LLOQ of 0.05 ng/10 mg hair for all six benzodiazepines, with all acceptance criteria satisfied. |
| Immunoassay Specificity (Cross-reactivity) | N/A (listed cross-reactivity percentages) | Varies significantly by compound (e.g., Clobazam 550%, Oxazepam 100%, Lorazepam 13%, 7-aminoclonazepam
§ 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).