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510(k) Data Aggregation
(202 days)
AMERICAN BIO MEDICA CORP.
The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen: Amphetamines, Barbiturates (Butalbital), Benzodiazepines (Oxazepam), Buprenorphine, Cocaine, MDMA (Methylenedioxymethamphetamine), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Tricyclic Antidepressants. The test is intended for over-the-counter use.
Rapid TOX Cup II is a drug test that can detect 1 to 13 drugs in human urine. Rapid TOX Cup II is collection cup with a temperature strip attached. It contains an insert with one or more test strips in the insert. Each test strip can test for up to 4 different drugs. The test is for over-the-counter or professional use. Rapid TOX CUP II is a first step in a 2-step process. The test provides information about the presence of certain drugs in urine. The second step in the process is more specific testing by a laboratory.
Here is a description of the acceptance criteria and the study proving the device meets them, based on the provided text:
This document describes the performance of the Rapid TOX Cup II, a urine drug screening device.
1. Table of Acceptance Criteria and Reported Device Performance
The device is an in vitro diagnostic test designed to qualitatively detect various drugs of abuse in human urine. The acceptance criteria are implicit in the "consumer study" results, which show the device's accuracy at different drug concentrations relative to predefined cutoffs. The "acceptance criteria" are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%), but rather demonstrated through the concordance of the device's positive and negative results with expected outcomes based on the spiked concentrations.
Below is a summary table demonstrating the device's performance for each tested drug across different concentrations, as reported in the consumer study. The "Rapid TOX Cup II Result" indicates how the device interpreted the prepared samples.
Table 1: Rapid TOX Cup II Reported Device Performance (Consumer Study Results)
| Drug Name | Cutoff (ng/mL) | Urine Sample Type (Ground Truth) | Rapid TOX Cup II Result (Device Performance) | Number of Samples |
|---|---|---|---|---|
| AMP (Amphetamines) | 500 | No Drug Present | NEGATIVE | 160 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 5 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 35 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| AMP (Amphetamines) | 1000 | No Drug Present | NEGATIVE | 580 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| BAR (Barbiturates) | 300 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| BZO (Benzodiazepines) | 300 | No Drug Present | NEGATIVE | 880 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| BUP (Buprenorphine) | 12.5 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| COC (Cocaine) | 150 | No Drug Present | NEGATIVE | 160 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| COC (Cocaine) | 300 | No Drug Present | NEGATIVE | 580 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | MEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| MDMA | 500 | No Drug Present | NEGATIVE | 80 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 4 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 36 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| MTD (Methadone) | 300 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| METH (Methamphetamine) | 500 | No Drug Present | NEGATIVE | 80 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| METH (Methamphetamine) | 1000 | No Drug Present | NEGATIVE | 500 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| OPI (Opiates) | 300 | No Drug Present | NEGATIVE | 160 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| OPI (Opiates) | 2000 | No Drug Present | NEGATIVE | 620 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| OXY (Oxycodone) | 100 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| PCP (Phencyclidine) | 25 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| THC (Marijuana) | 50 | No Drug Present | NEGATIVE | 960 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| TCA (Tricyclic Antidepressants) | 1000 | No Drug Present | NEGATIVE | 580 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 |
Interpretation of Performance:
The results indicate that:
- For samples with "No Drug Present" or "Less than 50% of the cutoff concentration," the device predominantly yielded NEGATIVE results, demonstrating high specificity below the cutoff.
- For samples "Between the cutoff and 50% above the cutoff concentration" and "Greater than 50% above the cutoff concentration," the device consistently yielded POSITIVE results, demonstrating high sensitivity at or above the cutoff.
- For samples "Between 50% below the cutoff and the cutoff concentration," there was a mix of positive and negative results, which is expected for lateral flow assays as performance at these "near cutoff" concentrations can vary. However, the majority of these samples still yielded NEGATIVE results, indicating appropriate cutoff performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The sample sizes vary per drug type and concentration level. For each drug and cutoff level, there were:
- Between 80 and 960 samples for "No Drug Present" (Negative).
- 20 samples for "Less than 50% of the cutoff."
- 40 samples for "Between 50% below the cutoff and the cutoff."
- 40 samples for "Between the cutoff and 50% above the cutoff."
- 20 samples for "Greater than 50% above the cutoff."
- This totals approximately 140 to 1080 samples per drug/cutoff combination for the consumer study. The document lists 17 unique drug/cutoff combinations, meaning the total number of individual tests performed in the consumer study would be significant.
- Data Provenance: The data was generated through a prospective consumer study. The document does not specify the country of origin for the data or the participants, but given the FDA submission, it is likely that the study was conducted in the United States or in accordance with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts and Qualifications: The document does not mention the use of human experts (e.g., radiologists) to establish ground truth for this medical device.
- Ground Truth Establishment: The ground truth for the test set was established by preparing samples with known concentrations of drug analytes. These are "spiked" samples with precise, known quantities of the drugs or their metabolites, relative to the device's specified cutoff levels. This is a common and robust method for establishing ground truth in in vitro diagnostic studies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the ground truth was established by known concentrations in prepared samples, there was no need for adjudication among human readers or experts. The device's output (positive/negative) was compared directly to the known concentration of the spiked sample.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers are involved in the interpretation process. The Rapid TOX Cup II is an in vitro diagnostic device that provides a direct "positive" or "negative" qualitative result.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted. The study's purpose was to show the device's performance when interpreted by "untrained consumers" in an OTC setting, comparing their interpretation of the device's visual readout to the true spiked concentrations, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Performance: Not explicitly separated as "algorithm only." The device itself (the Rapid TOX Cup II) is the "algorithm" in this context (a lateral flow immunoassay). The study evaluated how well untrained consumers could generate a result and interpret it from the physical device. Therefore, the reported performance is effectively the "standalone performance" of the device as it would be used by an end-user, including the user's interpretation of the visual output. The device is not an AI algorithm in the traditional sense that operates independently of a user interface or human input for interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was known, prepared concentrations of drug analytes in urine samples. This is a form of "laboratory-controlled" or "spiked sample" ground truth, which is highly precise and accurate for evaluating the analytical performance of in vitro diagnostic tests. While clinical outcomes or expert consensus might be used for other types of devices, for a rapid drug screen, known concentrations are the gold standard for analytical validation.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a "training set" in the context of machine learning or AI algorithm development. The Rapid TOX Cup II is a chemical immunoassay, not an AI or machine learning model. Therefore, the concept of a "training set" and "test set" in the AI sense does not apply to the device's development or validation in this document. The samples described were used for a performance validation study (akin to a test set in the analytical validation context).
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for an immunoassay device. The ground truth for the validation study (the "consumer study") was established by precisely preparing urine samples with known concentrations of drug analytes, as detailed in point 7.
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(212 days)
AMERICAN BIO MEDICA CORP.
Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels:
Amphetamine 1000 ng/mL
Amphetamine 500 ng/mL
Methamphetamine 1000 ng/mL
Methamphetamine 500 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL
Buprenorphine 12.5 ng/mL
Benzodiazepines (Oxazepam) 300 ng/mL
Barbiturates (Butalbital) 300 ng/mL
Oxycodone 100 ng/mL
Methadone 300 ng/mL
Phencyclidine 25 ng/mL
Propoxyphene 300 ng/mL
Opiates 300 ng/mL
Opiates 2000 ng/mL
Cocaine (Benzoylecgonine) 300 ng/mL
Cocaine (Benzoylecgonine) 150 ng/mL
Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL
THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) 50 ng/mL
'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS).
The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results.
There is no calibration necessary and therefore no calibrator needed for this device.
'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.
The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the highly specific reaction between antigens and antibodies.
Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all "test" areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled drug.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a colored line in any of the test areas is indicative of a presumptive positive result.
A control line, comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of a drug in the urine, and therefore, should be present in all reactions.
A negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample.
The device is contained in a polypropylene cup.
The provided document describes the "Rapid Tox Cup," a one-step, lateral flow immunoassay for the simultaneous detection of abused drugs in urine.
1. Acceptance Criteria and Reported Device Performance
The document presents targeted drug concentrations (cut-off levels) for detection. These can be considered the acceptance criteria for individual drug detection sensitivity. The study claims the device's performance is reproducible and equivalent to its predicate devices.
| Analyte (Drug) | Acceptance Criteria (Cut-off level) | Reported Device Performance (Specificity/Sensitivity) |
|---|---|---|
| Amphetamine | 500 ng/mL | Reproducible, equivalent to predicate devices |
| Amphetamine | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| Methamphetamine | 500 ng/mL | Reproducible, equivalent to predicate devices |
| Methamphetamine | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| 3,4-methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Reproducible, equivalent to predicate devices |
| 3,4-methylenedioxymethamphetamine (MDMA) | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| Buprenorphine | 12.5 ng/mL | Reproducible, equivalent to predicate devices |
| Benzodiazepines (Oxazepam) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Barbiturates (Butalbital) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Oxycodone | 100 ng/mL | Reproducible, equivalent to predicate devices |
| Methadone | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Phencyclidine | 25 ng/mL | Reproducible, equivalent to predicate devices |
| Propoxyphene | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Opiates | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Opiates | 2000 ng/mL | Reproducible, equivalent to predicate devices |
| Cocaine (Benzoylecgonine) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Cocaine (Benzoylecgonine) | 150 ng/mL | Reproducible, equivalent to predicate devices |
| Tricyclic Antidepressants (Nortriptyline) | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| THC/ Cannabinoids (11 nor△9-THC-9-carboxylic) | 50 ng/mL | Reproducible, equivalent to predicate devices |
Note: The performance is described as "reproducible" and "equivalent to predicate devices," but specific accuracy metrics (e.g., sensitivity, specificity, PPV, NPV) from the study are not provided in this summary. The performance is inferred from the demonstration of reproducibility and equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The reproducibility study used commercially available control urines.
- Sample Size: Each sample was tested 4 times, twice daily, for 5 days, for a total of 40 tests per sample. The specific number of distinct control urine samples (e.g., negative controls, above cut-off, below cut-off) used is not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be from a prospective study conducted for validation purposes, given the controlled testing conditions (commercially available control urines, specific testing regimen).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set (control urines) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a laboratory analytical method, not by human experts. Therefore, the information about the number and qualifications of experts is not applicable in this context.
4. Adjudication Method for the Test Set
Since the ground truth was established by GC/MS and the device provides a direct qualitative result (visible line or no line), there was no adjudication method described for resolving discrepancies in the test set. The results from the device were compared against the GC/MS verified concentrations.
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 done. The device is an immunoassay that provides a direct qualitative result, not an imaging device requiring human interpretation, so such a study would not be typically applicable. The comparison was the device's performance against GC/MS-verified samples.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The reproducibility study evaluated the performance of the "Rapid Tox Cup" by testing control urines multiple times and verifying concentrations by GC/MS. This assesses the algorithm's (or, in this case, the immunoassay's) performance without human-in-the-loop interpretation beyond reading the visible lines. It also explicitly states that the device in cup form houses identical strips used in predicate devices, and testing showed "no difference relative to results from the Rapid Tec or Rapid Tox products."
7. The Type of Ground Truth Used
The ground truth used for the test set was laboratory analytical confirmation by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted method for drug concentration verification.
8. The Sample Size for the Training Set
The document does not specify a distinct training set sample size. The description of the device's technology (immunoassay with immobilized drug conjugates and colloidal gold-antibody complex) suggests that its "training" or development involved setting up the specific chemical reactions and cutoff concentrations. While this process would involve extensive testing and optimization, the document refers to validation studies rather than a formal "training set" in the machine learning sense. The performance characteristics were evaluated using commercially available control urines for reproducibility.
9. How the Ground Truth for the Training Set Was Established
As with the test set, the ground truth for optimizing or validating the device's detection capabilities (analogous to a training set's ground truth in AI) would have been established through laboratory analytical methods, most likely GC/MS, to accurately determine drug concentrations in samples used during the development and optimization phases. The summary states that "All concentrations were verified by GC/MS" for the reproducibility study, indicating this method for ground truth establishment.
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(139 days)
AMERICAN BIO MEDICA CORP.
'RapidOne'-Buprenorphine Test is a one-step lateral flow immunoassay for the qualitative detection of 12.5 ng/ml of buprenorphine in human urine.
'RapidOne'-Buprenorphine Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. liquid chromatography/mass spectrometry (LC/MS).
'RapidOne'-Buprenorphine Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. LC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The assay employed in the "RapidOne"-Buprenorphine Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of buprenorphine-and buprenorphine glucuronide in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex. is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur, forming visible lines in the "test" area.
When drug is present in the urine sample, the drug or metabolite will compete with the drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug compage. An absence of a color band (Ime) in the "test" grea is indicative of a possive result.
A control band (line), comprised of a different autibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present on all reactions.
A negative will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that supports the device's performance:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated in Intent) | Reported Device Performance |
|---|---|
| Detection of buprenorphine at 12.5 ng/ml | "RapidOne'-Buprenorphine Test will detect buprenorphine at 12.5 ng/ml" |
| Detection of buprenorphine glucuronide at 10.0 ng/ml | "RapidOne'-Buprenorphine Test will detect buprenorphine glucuronide at 10.0 ng/ml" |
| Reproducibility for concentrations above and below cutoff | "The results confirmed the reproducibility of the 'RapidOne'-Buprenorphine Test performance." |
| Substantial equivalence to LC/MS | "'RapidOne' - Buprenor phine Test is substantially equivalent to the results obtained with LC/MS." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days."
- Sample Size for Test Set: The exact number of distinct urine samples used for the test set is not explicitly stated. However, it specifies that "Each sample was tested four times, twice daily, for five days," which means each distinct sample generated 40 individual test results (4 tests/day * 5 days * 2 sessions/day, but the text literally says "tested four times, twice daily, for five days", so it seems like 4 tests were done each day, twice a day, for 5 days. Or it means 4 tests in total, each done twice daily for 5 days to get reproducibility. The phrasing is a bit ambiguous. Assuming the simpler reading where "Each sample was tested four times" refers to 4 distinct test runs per sample over the 5 days, and then "twice daily" refers to the frequency of these test runs.). Given the ambiguity, we can't definitively state the total number of samples.
- Data Provenance: The document does not specify the country of origin of the data. It mentions "control urines," suggesting laboratory-prepared or validated samples rather than necessarily patient-derived, but this is not explicitly stated. It is a prospective study, as the device performance was being actively evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
The ground truth for the test set was established using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate analytical method. The document does not describe a human adjudication method in the traditional sense (e.g., 2+1, 3+1), as the ground truth was determined by an objective analytical instrument.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, and the performance evaluation focuses on its analytical accuracy and reproducibility against a gold standard analytical method (LC/MS and GC/MS), not on human reader interpretation.
6. Standalone Performance Study
Yes, a standalone (algorithm only, without human-in-the-loop performance) study was done. The "Performance Characteristics" section describes the device's ability to detect buprenorphine and buprenorphine glucuronide at specific concentrations and its reproducibility, all assessed directly by the device itself against validated "control urines" whose concentrations were confirmed by GC/MS and LC/MS.
7. Type of Ground Truth Used
The primary ground truth used for both detection limits and reproducibility was analytical confirmation by GC/MS and LC/MS. These are objective, laboratory-based analytical methods considered gold standards for drug detection and quantification.
8. Sample Size for the Training Set
The document does not mention a "training set" or a machine learning/AI component for this device. The RapidOne-Buprenorphine Test is described as an immunoassay based on the specific reactions between antigens and antibodies, implying a biochemical test, not one that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.
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(189 days)
AMERICAN BIO MEDICA CORP.
'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine. 'RapidOne'-Cocaine-150 Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS). 'RapidOne'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.
The assay employed in the 'RapidOne-Cocaine-150 Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of benzoyl ecgonine in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal goldantibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur, forming visible lines in the "test" area. When drug is present in the urine sample, the drug or metabolite will compete with the Drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled Antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug. conjugate. An absence of a color band (line) in the "test" area is indicative of a positive. A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present on all reactions. A negative urine will produce two colored bands, and a positive sample will produce only one band.
The 'RapidOne'-Cocaine-150 Test is a qualitative immunoassay for detecting benzoyl ecgonine in human urine. The study presented a limited set of performance data primarily focused on reproducibility, as the device was deemed "substantially equivalent" to a previously cleared device. Due to the nature of the submission (510(k) for substantial equivalence and the limited information provided in the summary), a full, detailed study report with all the requested information is not present. The information below is extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Detection Limit | Not explicitly stated as a separate criterion; implied to be 150 ng/ml for benzoyl ecgonine. | 'RapidOne'-Cocaine-150 Test will detect benzoyl ecgonine at 150 ng/ml. |
| Reproducibility | Consistent and accurate results across multiple tests, across concentrations above/below cutoff. | Confirmed by testing control urines (above/below cutoff and negative) four times daily for five days. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The study mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls were also used." It also states "Each sample was tested four times, twice daily, for five days," which implies repeat testing of a smaller set of samples rather than a large test set for overall performance.
- Data Provenance: Not specified. The summary does not provide details about the origin of the urine samples (e.g., country of origin, retrospective or prospective collection).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable/not stated.
- Qualifications of Experts: Not applicable/not stated. Ground truth for performance was established using GC/MS.
4. Adjudication Method
- Adjudication Method: Not applicable. Human experts were not involved in establishing the ground truth for this performance study; GC/MS was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a standalone in-vitro diagnostic test.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the described performance relates to the standalone performance of the device without human-in-the-loop assistance beyond the usual interpretation of a qualitative test result (presence/absence of a line). The study focuses on the device's ability to detect the analyte at a specified concentration.
7. Type of Ground Truth Used
- Ground Truth Type: Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "All concentrations were verified by GC/MS." and "GC/MS is the preferred confirmatory method."
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not stated. This type of immunoassay device does not typically involve a "training set" in the context of machine learning algorithms. Its design and cutoff are based on established biochemical principles and often validated against known concentrations.
9. How Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. As mentioned above, a training set is not relevant for this immunoassay's development. The cutoff and performance characteristics are based on the immunoassay's design and validated using reference methods like GC/MS.
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(174 days)
AMERICAN BIO MEDICA CORP.
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
| Compound | Test
Abbreviation | Level (ng/ml) |
|----------------------------------------------------------|----------------------|---------------|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 |
| Barbiturates (secobarbital) | BAR | 300 |
| Benzodiazepine (oxazepam) | BZO | 300 |
| Cocaine (benzoylecgonine) | COC | 300 |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 |
| Methadone | MTD | 300 |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 300 |
| | | 2000 |
| Oxycodone | OXY | 100 |
| Phencyclidine (phencyclidine HCI) | PCP | 25* |
| Propoxyphene/Norpropoxyphene | PPX | 300 |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 |
Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
The provided document describes the FDA 510(k) clearance for the RapidTox™ device, a lateral flow immunoassay for detecting drugs of abuse in urine. However, it does not contain explicit information regarding acceptance criteria, a detailed study design, or specific performance metrics (like sensitivity, specificity, accuracy) derived from such a study.
The document primarily focuses on the regulatory submission and FDA's determination of substantial equivalence to predicate devices, along with the device's intended use and detection levels for various substances.
Therefore, many of the requested details cannot be extracted directly from this document. I will fill in what can be inferred or stated based on the given text and indicate where information is missing.
Acceptance Criteria and Device Performance (Inferred/Not Explicitly Stated)
The document lists the detection levels for various compounds. For a lateral flow immunoassay in a regulatory context, acceptance criteria would typically revolve around demonstrating that the device can accurately detect these compounds at or above the specified cutoff levels (sensitivity) and not produce false positives in the absence of the drug (specificity).
Table of (Inferred) Acceptance Criteria and Device Performance
| Compound | Test Abbreviation | Target Cutoff Level (ng/ml) | Reported Performance (Inferred from device's function as a "qualitative detection" at specified levels) |
|---|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 | Qualitatively detects Amphetamine at or above 1000 ng/ml. |
| Barbiturates (secobarbital) | BAR | 300 | Qualitatively detects Barbiturates at or above 300 ng/ml. |
| Benzodiazepine (oxazepam) | BZO | 300 | Qualitatively detects Benzodiazepine at or above 300 ng/ml. |
| Cocaine (benzoylecgonine) | COC | 300 | Qualitatively detects Cocaine at or above 300 ng/ml. |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 | Qualitatively detects MDMA at or above 1000 ng/ml. |
| Methadone | MTD | 300 | Qualitatively detects Methadone at or above 300 ng/ml. |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 | Qualitatively detects Methamphetamine at or above 1000 ng/ml. |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 2000 | Qualitatively detects Opiates at or above 2000 ng/ml. |
| Oxycodone | OXY | 100 | Qualitatively detects Oxycodone at or above 100 ng/ml. |
| Phencyclidine (phencyclidine HCl) | PCP | 25* | Qualitatively detects Phencyclidine at or above 25 ng/ml. |
| Propoxyphene/Norpropoxyphene | PPX | 300 | Qualitatively detects Propoxyphene/Norpropoxyphene at or above 300 ng/ml. |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* | Qualitatively detects THC/Cannabinoids at or above 50 ng/ml. |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 | Qualitatively detects Tricyclic Antidepressants at or above 1000 ng/ml. |
Note: The actual acceptance criteria (e.g., minimum sensitivity and specificity percentages) for the study are not specified in this document, only the target detection levels.
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For drug tests, ground truth is typically established by a gold standard laboratory method.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Adjudication methods are typically used when subjective expert interpretation is involved. For a diagnostic test like this, a confirmatory objective method is usually employed as the ground truth.
-
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:
- Not Applicable. The RapidTox™ is a lateral flow immunoassay, a diagnostic device that produces a visual result (lines) for drug detection. It is not an AI-powered system, nor does it involve human "readers" in the sense of image interpretation where an AI would assist. Its interpretation is generally objective based on the presence or absence of a line.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As noted above, this is not an AI algorithm. Its performance is inherent to the chemical reactions and design of the immunoassay itself in detecting the target analytes. The device is standalone in the sense that it provides a direct qualitative result without further interpretation by an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document states: "More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
- Therefore, the ground truth used for validating the immunoassay would be GC/MS (Gas Chromatography/Mass Spectrometry), which is an objective, highly accurate analytical method for drug identification and quantification.
-
The sample size for the training set:
- Not Applicable. This is a traditional immunoassay, not a machine learning or AI model, so there is no "training set" in the computational sense. The device's performance is developed and optimized through chemical formulation and engineering, not algorithm training.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply to this device. The 'ground truth' for the development and validation of the immunoassay itself (e.g., establishing the reactivity of antibodies, optimizing cutoff levels) would be based on precise laboratory measurements using known concentrations of analytes and reference methods like GC/MS.
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(385 days)
AMERICAN BIO MEDICA CORP.
The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS).
The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of abuse test results using Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC tests"). The Rapid Reader is used to obtain qualitative results and is intended for professional use only. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides a preliminary indication of drugs in urine. Results should be confirmed using appropriate confirmation methods. i.e., gas-chromatography/mass spectrometry (GC/MS).
The Rapid Reader utilizes a digital camera, pictures are analyzed using software algorithm developed to read any of American Bio Medica Corporation's (ABMC's) drugs of abuse screening immunoassays. These immunoassays include the Rapid Drug Screen®, Rapid One®, or Rapid TEC® drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine. All of these tests have been previously FDA cleared as Class II devices.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correctly identified drug-free specimens as negative (equivalent to manual interpretation). | The Rapid Reader interpretation and manual interpretation correctly identified 100% of drug-free specimens as negative. |
| Correctly identified specimens containing drug at a concentration above cutoff as positive (equivalent to manual interpretation). | The Rapid Reader interpretation and manual interpretation correctly identified 100% of specimens containing drug at a concentration above the cutoff level for each of the 14 drugs of abuse as positive. |
| Qualitative results equivalent to manual read test results. | The study implicitly demonstrates this by showing 100% concordance with manual interpretation for both negative and positive results across all tested drugs. The conclusion states: "The evaluation has led to the assurance that the performance of the Rapid Reader in correctly interpreting the ABMC test result is equivalent to the performance of reading the test manually." |
Study Details:
-
Sample size used for the test set and the data provenance: Not explicitly stated. The text mentions "Certified negative and positive controls for each of the 14 drugs of abuse were tested," suggesting a set of controlled samples. The provenance (country of origin, retrospective/prospective) is not specified, but the study inherently appears prospective in nature as it describes an evaluation being conducted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Three "untrained professionals" performed the manual interpretation which served as the reference for comparison. Their specific qualifications beyond "untrained professionals" are not provided.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated, but the process implies direct comparison of the Rapid Reader's output to the manual interpretation by the three "untrained professionals." It's not clear if there was a formal adjudication process if these three professionals disagreed amongst themselves.
-
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 comparative effectiveness study, in the typical sense of measuring human reader improvement with AI assistance, was not performed. This study compared the device (Rapid Reader) against manual human interpretation, not human readers with and without AI assistance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the described study is a standalone performance evaluation. The Rapid Reader generated results independently, which were then compared to human manual interpretation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by "manual interpretation (human eye interpretation)" performed by three "untrained professionals," combined with the use of "certified negative and positive controls" for each drug. This is a form of expert consensus/reference standard.
-
The sample size for the training set: Not provided. The document focuses exclusively on the performance evaluation of the Rapid Reader, not its development or training data.
-
How the ground truth for the training set was established: Not provided.
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(133 days)
AMERICAN BIO MEDICA CORP.
Ask a specific question about this device
(66 days)
AMERICAN BIO MEDICA CORP.
'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.
'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)
'Rapid One'-Propoxyphene Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.
The assay employed in the 'Rapid One'-Propoxyphene Test is based on the same principle of highly specific reactions between antigens and antibodies.
This assay is a one-step, competitive, immunoassay for the detection of propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.
When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
Device Name: 'Rapid One'-Propoxyphene Test
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in terms of specific performance targets (e.g., sensitivity, specificity, accuracy percentages) that the device must meet. Instead, it describes the expected performance and successful reproducibility.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Detection of propoxyphene or norpropoxyphene at 300 ng/ml. | "‘Rapid One’-Propoxyphene Test will detect propoxyphene or norpropoxyphene at 300 ng/ml." |
| Reproducibility of results (above/below cut-off, negative). | "The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance." |
| Consistent control band presence for all reactions. | "The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions." |
| Visual distinction between positive (one band) and negative (two bands) samples. | "A negative urine will produce two colored bands, and a positive sample will produce only one band." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states: "Each sample was tested four times, twice daily, for five days." It also mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls." However, the total number of distinct samples (e.g., individual patient urine samples) used for the reproducibility study is not specified.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the testing was performed in a controlled laboratory setting. The data is prospective as it involves the preparation and testing of control urines for the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable, as the ground truth was established by analytical methods, not expert interpretation.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth (drug concentration) was objectively verified by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold-standard analytical method for drug confirmation. There was no mention of human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted or described. This type of study is typical for imaging devices where human interpretation is a primary component. The 'Rapid One'-Propoxyphene Test is an in vitro diagnostic immunoassay with a direct visual output, not requiring human interpretation of complex images or data in the same way.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the described performance relates to the device itself performing the test and producing results. The statement "The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance" explicitly refers to the device's ability to provide consistent outputs. This is a standalone performance assessment in that it's the test kit's output without human influence on the result generation, though human observation is needed to visually read the bands.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test samples (drug concentrations) was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and confirmatory analytical method for drug detection and quantification. The document states: "All concentrations were verified by GC/MS."
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an immunoassay kit, not a machine learning or AI-based algorithm that requires a separate "training set." The performance is inherent to the chemical and biological components of the test.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of medical device.
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(161 days)
AMERICAN BIO MEDICA CORP.
'RapidTec'-5M-Multiple Drug Test is used for the qualitative detection of the following abused substances in human urine: methamphetamines, benzoyl ecgonine, phencyclidine, opiates and cannabinoids. This immunoassay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)
'RapidTec'-5M-Multiple Dip Test is a onc-step lateral flow immunoassay for the simultaneous qualitative detection of methamphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine.
The assays employed in the 'RapidTec'-5M-Multiple Dip Test is based on the same principle of highly specific reactions between antigens and antibodies.
This assay is a one-step, competitive, immunoassay for the detection of marijuana, opiates, phencyclidine, cocaine and methamphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.
When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.
A negative urine will produce six colored bands, and a positive sample will produce only one band.
The provided text describes the 'RapidTec'-5M-Multiple Dip Test, an immunoassay for detecting various drugs in human urine. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the stated cut-off concentrations for each drug. The device is expected to detect drugs at or above these levels. The performance (reproducibility) was evaluated against these criteria.
| Drug Constituent | Acceptance Criteria (Cut-off Concentration) | Reported Device Performance (Detection at or above concentration) |
|---|---|---|
| Methamphetamine | 1000 ng/ml | Reproducibility confirmed at 1000 ng/ml |
| Benzoyl ecgonine | 300 ng/ml | Reproducibility confirmed at 300 ng/ml |
| Cannabinoids | 50 ng/ml | Reproducibility confirmed at 50 ng/ml |
| Phencyclidine | 25 ng/ml | Reproducibility confirmed at 25 ng/ml |
| Opiates | 2000 ng/ml | Reproducibility confirmed at 2000 ng/ml |
| Opiates | 300 ng/ml | Reproducibility confirmed at 300 ng/ml |
| (Note: Opiates have two listed detection levels in the 'Performance Characteristics' section, which could indicate different specific opiates or varying sensitivity levels within the opiate class. For the purpose of this table, both are included as reported performance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the reproducibility study, each sample (control urines containing concentrations above and below the cut-off, as well as negative controls) was tested four times, twice daily, for five days. The total number of individual samples or unique urine specimens is not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The text does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
- Not applicable, as expert adjudication is not mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The study described focuses on device reproducibility rather than human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, the study described is a standalone performance study. The device's reproducibility in detecting drug metabolites at specified cut-off levels was evaluated independently.
7. Type of Ground Truth Used
- GC/MS (Gas Chromatography/Mass Spectrometry): The concentrations of drugs in the control urines were "verified by GC/MS." This indicates that GC/MS was used as the reference standard or "ground truth" to confirm the actual drug levels in the samples used for testing the device's reproducibility.
8. Sample Size for the Training Set
- The document describes performance testing of a device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an algorithm. The ground truth for the test samples was established using GC/MS (as mentioned in point 7).
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(109 days)
AMERICAN BIO MEDICA CORP.
'RapidTec'-5 A-Multiple Dip Test is a one-step lateral flow immunoassay for the simultaneous qualitative detection of amphetamines, benzovl ecgonine, cannabinoids, phencyclidine, and opiates in urine.
'RapidTec' - 5 A-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatorgraphy/mass spectrometry (GC/MS.)
'Rapid Tec'-5A-Multiple Dip Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.
The assays employed in the 'RapidTec'-5A-Multiple Dip Test is based on the same principle of highly specific reactions between antigens and antibodies.
This assay is a one-step. competitive, immunoassay for the detection of marijuana. opiates, phencyclidine, cocaine and amphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.
When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
Acceptance Criteria and Device Performance
The device's acceptance criteria are defined by its ability to accurately detect specific drugs in human urine at or above set cut-off concentrations. The study described confirms that the device meets these criteria through reproducibility testing.
Table of Acceptance Criteria and Reported Device Performance:
| Drug | Acceptance Criteria (Cut-off Concentration) | Reported Device Performance (Detection at or above cut-off) |
|---|---|---|
| Amphetamine | 1000 ng/ml | Detected |
| Benzoyl ecgonine | 300 ng/ml | Detected |
| Cannabinoids | 50 ng/ml | Detected |
| Phencyclidine | 25 ng/ml | Detected |
| Opiates | 2000 ng/ml | Detected |
Note: The table in the original document lists "Opiates" twice with different concentrations (2000 ng/ml and 300 ng/ml). Assuming the 2000 ng/ml is the primary cut-off for "Opiates" and the 300 ng/ml might be for a specific opiate metabolite not explicitly named, or there's a typo. For this summary, I'll list the two distinct values as they appear.
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: The document states that "control urines" were used, including concentrations above and below the stated cut-off, as well as negative controls. Each sample was tested four times, twice daily, for five days. The exact number of distinct "control urines" or individual patients is not specified.
- Data Provenance: Not explicitly stated. The study seems to be a lab-based reproducibility study. There is no mention of country of origin or if it's retrospective or prospective patient data. It appears to be an experimental setup using controlled urine samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established through instrumental analysis.
- Qualifications of Experts: Not applicable.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. Ground truth was established by GC/MS, an objective chemical method, not human interpretation requiring adjudication.
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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:
- MRMC Study: No. This is a standalone diagnostic test, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the device's performance (its ability to detect drugs at given cut-offs) was evaluated in a standalone manner. The "RapidTec'-5A-Multiple Dip Test" is a device that produces a visual result (lines) based on its internal chemical reactions, and its accuracy was verified against GC/MS. The document implies a human reads the results (presence or absence of lines), but the performance itself is of the device's chemical assay, verified against an independent chemical method.
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The type of ground truth used:
- Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All concentrations were verified by GC/MS."
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a lateral flow immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. Its performance is based on its chemical design and manufacturing consistency.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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