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510(k) Data Aggregation
(145 days)
The OTI Benzodiazepines Intercept® MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device using a 1.0 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE.
The OTI Benzodiazepines Intercept® MICRO-PLATE EIA provides only a preliminary analytical test result. A more specific alternative chemical method should be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry/mass spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed.
The OT1 Benzodiazepines Intercept® MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an ELA well containing an oral fluid specimen positive for benzodiazepines, there is a competition between the drug and the enzymelabeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of benzodiazepines present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for benzodiazepines testing using oral fluid, OTI recommends a cutoff of 1.0 ng/mL when testing oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. This cutoff is within the limit of detection by the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.
Here's an analysis of the provided text regarding the OTI Benzodiazepines Intercept® MICRO-PLATE EIA, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance characteristics of the proposed device alongside those of a legally marketed predicate device (Abuscreen ONLINE® kit for Benzodiazepines). The implication is that the proposed device's performance should be "essentially equivalent" to the predicate. Therefore, the "acceptance criteria" are inferred to be the performance ranges/values of the predicate device for each characteristic, and the "reported device performance" is the measured performance of the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.
| Performance Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (OTI Benzodiazepines Intercept® MICRO-PLATE EIA) |
|---|---|---|
| Precision | ||
| Intra-assay %CV range | 2-7% | 4.9-6.5% |
| Inter-assay %CV range | 2-10% | 7.6-11.4% |
| Limit of Detection | < 10 ng/mL | 0.2 ng/mL |
| % Cross-Reactivity | ||
| α-Hydroxyalprazolam | 112% | 10% |
| α-Hydroxytriazolam | 98% | 15% |
| Alprazolam | 96% | 151% |
| 7-Aminoflunitrazepam | Not tested (for predicate) | 6% |
| 7-Aminonitrazepam | 52% | 8% |
| Bromazepam | 75% | 2% |
| Clorazepate | 43% | 70% |
| Chlordiazepoxide | 55% | 6% |
| Clonazepam | 56% | 1% |
| Desalkylflurazepam | 49% | 17% |
| Diazepam | 105% | 135% |
| Estazolam | Not tested (for predicate) | 130% |
| Flurazepam | 61% | 49% |
| 2-Hydroxyethylflurazepam | 88% | 8% |
| Lorazepam | 59% | < 1% |
| Medazepam | 40% | 17% |
| Midazolam | 96% | 49% |
| Nitrazepam | 81% | 39% |
| Norchlordiazepoxide | Not tested (for predicate) | 3% |
| Oxaprozin | Not tested (for predicate) | <1% |
| Oxazepam | 98% | 7% |
| Prazepam | 84% | 107% |
| Temazepam | Not tested (for predicate) | 55% |
| Triazolam | 96% | 26% |
| Clinical Accuracy | N=50 confirmed positive (Predicate) 42 positive, 8 negative (Predicate) | Summarized in a table comparing Intercept results to GC/MS/MS results for 149 specimens. |
Study Proving Device Meets Acceptance Criteria:
The "Summary of Performance Data" section ({1}) describes the studies conducted to demonstrate the performance characteristics of the OTI Benzodiazepines Intercept® MICRO-PLATE EIA. The overall conclusion is that "This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the "Clinical Accuracy" study, a total of 149 specimens were collected and analyzed.
- Data Provenance: The document states "Three separate population studies were performed," implying the data was collected specifically for this purpose (prospective), but does not specify the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used for establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set. The ground truth was established by Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS).
5. 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 device is an in vitro diagnostic (IVD) immunoassay kit, not an AI-powered diagnostic imaging or screening tool that would involve human readers interpreting results with or without AI assistance. Therefore, no MRMC comparative effectiveness study was done in the context of human reader improvement with AI. The study compares the performance of the device itself against a confirmed analytical method (GC/MS/MS).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance study for the OTI Benzodiazepines Intercept® MICRO-PLATE EIA is essentially a standalone performance study. The device, an immunoassay kit, functions as an algorithm (chemical reaction leading to a detectable signal) to detect benzodiazepines. Its results are directly compared to the gold standard (GC/MS/MS) without human interpretation as part of the core performance evaluation, though human judgment is recommended for interpreting preliminary positive results.
7. The Type of Ground Truth Used:
The primary ground truth used for verifying the clinical accuracy of the OTI Benzodiazepines Intercept® MICRO-PLATE EIA was Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS). The document explicitly states: "(GC/MS/MS) is the preferred confirmatory method."
8. The Sample Size for the Training Set:
The document does not specify a separate training set or its sample size. For IVD devices like this, the "development" phase involving internal testing and optimization by the manufacturer might be analogous to a training phase, but it's not structured or reported in the same way as machine learning model training sets. The reported performance data is from a test set.
9. How the Ground Truth for the Training Set Was Established:
As no distinct training set is identified or its ground truth described, this information is not provided in the document. The ground truth for the evaluation was established using GC/MS/MS.
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