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510(k) Data Aggregation
(527 days)
The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.
| Test | Cutoff |
|---|---|
| Oratect® Oral Fluid Drug Screen Device d-Amphetamine | 50 ng/mL |
| Oratect® Oral Fluid Drug Screen Device d-Methamphetamine | 50 ng/mL |
| Oratect® Oral Fluid Drug Screen Device Delta-9-Tetrahydrocannabinol | 40 ng/mL |
| Oratect® Oral Fluid Drug Screen Device Cocaine | 20 ng/mL |
| Oratect® Oral Fluid Drug Screen Device Morphine | 40 ng/mL |
| Oratect® Oral Fluid Drug Screen Device Phencyclidine | 10 ng/mL |
These products are for in vitro diagnostic use and intended for prescription point of care use.
The Orated® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect® Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.
The Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.
Acceptance Criteria and Device Performance for Oratect® Oral Fluid Drug Screen Devices
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the document consistently uses "Accuracy results against reference method >90%" as the performance metric for the subject device and "Accuracy results against reference method >89%" for the predicate. For the purpose of this summary, we will infer the acceptance criterion to be >90% accuracy against a reference method.
The reported device performance based on the "Accuracy" row in the comparison table is also >90% against reference method.
| Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Accuracy (against reference method) | >90% | >90% |
| Precision | Not explicitly stated, but predicate's <10% imprecision is noted. For the subject device, "overall precision was above 90%" | "overall precision was above 90%" |
| Cross-reactants and Interference compounds | Not explicitly stated, but "very specific antibodies" and lists in package insert are noted. | "very specific antibodies for their respective test. Only a limited number of structure related chemicals cross react with the tests." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "analytical performance validation studies, precision site studies and in method comparison studies".
- Sample Size: The document does not explicitly state the total sample size used for the test set in the "method comparison studies." It mentions "three (3) Point of Care (POC) sites" for the precision study, but not the number of samples at each site or for the overall accuracy study.
- Data Provenance: The data provenance is not explicitly stated (e.g., country of origin, specific demographics). The studies are referred to as "analytical" and "clinical" performance tests, implying human samples were involved. It is likely retrospective data collected for validation, as no prospective clinical trial details are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The study primarily focuses on comparing the subject device's performance against reference laboratory methods (LC/MS or GC/MS) and its predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
The device itself, the "Oratect® Oral Fluid Drug Screen Device," is a standalone immunoassay device. The performance described (accuracy, precision, specificity) is inherently its standalone, algorithm-only (or device-only) performance, as it produces a visually interpreted result without human-in-the-loop assistance beyond the interpretation of the test lines.
7. Type of Ground Truth Used
The ground truth used for the comparison studies was established by "LC/MS or GC/MS reference test method." These are highly specific and quantitative laboratory methods considered the definitive gold standard for drug detection.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. Immunoassay devices like the Oratect® generally do not involve machine learning algorithms that require a distinct training set in the typical sense. Their performance is validated through analytical and clinical studies as described.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of machine learning, there is no information on how a ground truth for such a set was established. The performance validation relies on comparing the device's results to established reference methods (LC/MS or GC/MS) for individual samples.
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(84 days)
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are rapid immunochromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. The devices are intended for professional use only. They are not intended for over-the-counter sale to non-professionals.
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard tests are used to obtain visual, qualitative results. A more specific alternate method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS are the preferred confirmatory methods.
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are based on the principle of highly specific immunochemical reactions between antigens and antibodies. Both devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. If Buprenorphine is present in the urine, it competes with the immobilized drug conjugate for the limited binding sites on the colored antibody colloidal gold conjugate. When a sufficient amount of drug is present, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug conjugate immobilized on the membrane. Thus, the absence of the purple-red band at the test region indicates a preliminary positive result. However, if there is no drug present to compete for the binding sites of the colored colloidal gold conjugate, it binds to the immobilized drug conjugate to form a visible purple-red band at the test region of the membrane. Thus, the presence of a purple-red band at the test region indicates a negative result. The Fastect II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests can be performed without the use of any additional instruments.
A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.
The provided text describes the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices, which are immunochromatographic tests for the qualitative detection of Buprenorphine in human urine. The acceptance criteria are based on their accuracy in detecting Buprenorphine at a cut-off concentration of 10 ng/ml compared to GC/MS analysis and a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the desired agreement with GC/MS and the predicate device. The performance is reported as percent agreement.
Fastect® II BUP Drug Screen Dipstick Test
| Category | Acceptance Criteria (Implied) | Reported Device Performance (% Agreement with GC/MS) |
|---|---|---|
| Positive (+) | High Agreement | 100% |
| Negative (-) | High Agreement | 94% |
QuickTox® Drug Screen Dipcard Test
| Category | Acceptance Criteria (Implied) | Reported Device Performance (% Agreement with GC/MS) |
|---|---|---|
| Positive (+) | High Agreement | 100% |
| Negative (-) | High Agreement | 94% |
Note: The acceptance criteria are not explicitly stated as numerical targets (e.g., "95% agreement"). Instead, the study reports the observed agreement to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample size: A total of 90 urine specimens were evaluated.
- Data provenance: 50 urine samples were clinical specimens, meaning they were obtained from patients. The remaining samples (40) were likely laboratory-prepared or spiked samples to ensure representation across different concentration ranges. These were previously analyzed by GC/MS.
- Country of origin: Not specified.
- Retrospective or prospective: The description states "clinical specimens previously analyzed by GC/MS," which indicates a retrospective collection and analysis for the clinical samples. The preparation of "near-negative" and "near-positive" samples suggests some prospective manipulation of existing samples or creation of new ones.
3. 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 ground truth was established by GC/MS analysis, which is an analytical laboratory method, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None in the context of human adjudication. The ground truth was established by GC/MS analysis, an objective laboratory method.
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
- No, an MRMC study was not done. This device is a rapid immunochromatographic test, and its interpretation is typically straightforward (presence or absence of a band). There is no mention of human readers assisting an AI, or vice versa. The comparison was between the device's results, a predicate device, and GC/MS.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The "accuracy" study directly compared the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices' results against GC/MS analysis, without human interpretation influencing the device's output. The devices themselves produce a visual result (presence/absence of a band) which is then read. While a human reads the band, the "performance" described refers to the device's ability to produce the correct band pattern.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for confirming the presence and concentration of substances like Buprenorphine in urine.
8. The sample size for the training set
- The text does not explicitly mention a training set sample size. This document describes performance validation for a medical device (screening test), not the development and training of a machine learning model. The devices are based on immunochemical reactions, not algorithms that require training data in the typical sense.
9. How the ground truth for the training set was established
- As the device is based on immunochemical principles rather than a machine learning algorithm, the concept of a "training set" and its "ground truth establishment" in the AI/ML context is not applicable. The underlying chemical reactions are inherently designed to detect the target analyte. The performance studies mentioned are for validation and verification, not for training a model.
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