(164 days)
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of amphetamine in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of cocaine (benzoylecgonine) in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of methamphetamine in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for health care professional including point of care use.
The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for home use.
The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained.
The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained.
The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained.
The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 100 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained.
The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained.
The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, tricyclic antilegressant in urine. The malti-drug of absoce wine test device shows the drug was not present at the cutoff level. This test provides only a preliminary result. A more specifical nethod must be used in order to obtain a confirmed analy. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liguid Chromatography (HPLC) is the preferred confirmatory nethod. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liquid Chromatography (HPLC) 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 obtained.
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-amphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with amphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti- benzoylecgonine (cocaine) antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with benzoylecnine-BTG, and the C line is coated with goat anti-rabbit
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-methamphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with methamphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during test regardless of the presence of the drug.
A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during test regardless of the presence of the drug.
The provided texts describe the acceptance criteria and performance of several in-vitro diagnostic devices for drug abuse testing. It outlines the sensitivity, specificity, accuracy, and reproducibility of tests for Amphetamine, Cocaine, Methamphetamine, Oxycodone (at two different cutoffs), and a Multi-Drug of Abuse Urine Test. The study primarily relies on comparison to GC/MS data for accuracy and general laboratory studies for reproducibility.
Here's a structured breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied to be "substantially equivalent" to predicate devices, and the performance metrics (sensitivity, specificity, accuracy, reproducibility) are reported. The provided cut-off levels are also part of the performance specification.
| Performance Metric | Accepted Criteria (Implied by Predicate Equivalence & Regulatory Standards) | INSTANT-VIEW® Amphetamine (300) Urine Test | INSTANT-VIEW® Cocaine (150) Urine Test | INSTANT-VIEW® Methamphetamine (300) Urine Test | INSTANT-VIEW® Oxycodone (100) Urine Test | INSTANT-VIEW® Oxycodone (300) Urine Test | INSTANT-VIEW® Multi-Drug of Abuse Urine Test (Select Drugs from List based on individual clearances) |
|---|---|---|---|---|---|---|---|
| Sensitivity | Not explicitly stated as a numerical criterion, but expected to be high and comparable to predicate. | 93.5% | 96.4% | 96.8% | 97.6% | 95.2% | Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." |
| Specificity | Not explicitly stated as a numerical criterion, but expected to be high and comparable to predicate. | 98% | 98.1% | 98% | 97.6% | 100% | Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." |
| Accuracy (Overall Agreement to GC/MS) | Not explicitly stated as a numerical criterion, but expected to be high and comparable to predicate. | 96.9% | 97.2% | 96.1% | 97.6% | 98.3% | Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." |
| Reproducibility (Agreement across sites) | Not explicitly stated as a numerical criterion, but expected to be high. | 97.5% | 97.9% | 97.1% | 96.7% | 97.5% | Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." |
| Shelf Life Stability | Not explicitly stated as a numerical criterion, but demonstrated to be sufficient. | Predicted 2 years (24 months) | Predicted 2 years (24 months) | Predicted 2 years (24 months) | Predicted 2 years (24 months) | Predicted 2 years (24 months) | Predicted 2 years (24 months) |
| Urine Specific Gravity & pH Effect | No significant effect expected within a defined range. | No effect for specific gravity 1.002-1.035, pH 3.0-9.0 | No effect for specific gravity 1.002-1.035, pH 3.0-9.0 | No effect for specific gravity 1.002-1.035, pH 3.0-9.0 | No effect for specific gravity 1.002-1.035, pH 3.0-9.0 | No effect for specific gravity 1.002-1.035, pH 3.0-9.0 | No effect for specific gravity 1.002-1.035, pH 3.0-9.0 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Amphetamine (300):
- Sample Size: 98 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified but the manufacturing company is US-based). The studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa, suggesting real-world clinical data. Retrospective based on "clinical confirmed specimens."
- Cocaine (150):
- Sample Size: 108 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
- Methamphetamine (300):
- Sample Size: 127 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
- Oxycodone (100):
- Sample Size: 75 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
- Oxycodone (300):
- Sample Size: 115 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
- Multi-Drug of Abuse Urine Test: The performance characteristics (accuracy, reproducibility, sensitivity and specificity) are stated to be "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." This implies that the sample sizes and provenance for the multi-drug panel are derived from the individual drug tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC). These are analytical laboratory methods, not human experts. Therefore, the concept of "number of experts" or "qualifications" for establishing the ground truth as defined in this context is not applicable. The professionals operating these instruments would be trained laboratory personnel.
4. Adjudication Method for the Test Set
The primary "adjudication" for the test results is the comparison against the GC/MS data. This is a direct comparison to a gold standard analytical method, not an expert adjudication process in the traditional sense of multiple human readers. The summary also notes that "Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained," indicating that final clinical decisions would involve human judgment, but the device performance is directly compared to GC/MS.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described as being performed to compare human readers with and without AI assistance. These are standalone in-vitro diagnostic devices (immunoassays), not AI-assisted diagnostic tools for human interpretation. The "Reproducibility" studies involved personnel with diverse educational backgrounds and working experiences, but this was to assess device consistency, not human reader improvement with AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, the studies described are for the standalone performance of the in-vitro diagnostic devices (the test cassettes/dip-strips themselves). The sensitivity, specificity, and accuracy are reported for the device's ability to detect the targeted substances compared to the GC/MS gold standard, without a human-in-the-loop component influencing the device's measurement. The "professional and point of care use only" and "health care professional use" statements indicate human involvement for interpretation and clinical decision-making, but the performance data presented is for the device's analytical capability.
7. The Type of Ground Truth Used
The type of ground truth used is analytical gold standard comparison, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) data. This is explicitly stated as the "preferred confirmatory method" to obtain a "confirmed analytical result."
8. The Sample Size for the Training Set
The documents do not explicitly mention a separate "training set" or its sample size. These are immunoassay devices, and the development process would involve formulation, optimization, and validation, rather than a distinct "training set" as understood in machine learning contexts. The clinical confirmed specimens mentioned primarily refer to the test/validation set for assessing performance metrics like accuracy, sensitivity, and specificity against the gold standard.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" with established ground truth is not explicitly mentioned or relevant in the context of these in-vitro diagnostic (IVD) immunoassay devices (as opposed to machine learning algorithms), this question is not directly applicable. The device's underlying chemical and immunological principles are pre-determined during its design and manufacturing, rather than "trained" on data.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).