(82 days)
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level ng/mL |
|---|---|
| Amphetamine (AMP) | 500 or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepines (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level ng/mL |
|---|---|
| Amphetamine (AMP) | 500 or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepines (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses, It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-A9-THC-9 COOH | 50 |
AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d.l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
The provided document describes the acceptance criteria and the studies conducted for the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel for the detection of various drugs in human urine. The submission primarily focuses on the three new analytes: Amphetamine 1000, Cocaine 300, and Methamphetamine 1000, while referencing a previous submission (K182738) for other analytes.
Here's an breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for qualitative drug tests typically revolve around the ability to correctly identify samples above and below the specified cut-off concentrations. The precision study results implicitly serve as the performance criteria, showing the percentage of correct identifications at various concentrations relative to the cut-off.
Acceptance Criterion: The device should consistently provide correct positive results for samples at or above the cut-off concentration and correct negative results for samples significantly below the cut-off concentration. For samples near the cut-off, a certain degree of variability is expected but needs to be within acceptable ranges (e.g., majority of results correctly identified).
Reported Device Performance (from Precision Studies - 3 lots, 25 replicates each, total 75 tests per concentration level):
| Drug (Cut-off ng/mL) | Concentration (% of Cut-off) | Cup: % Correct Negative (Expected Negative) | Cup: % Correct Positive (Expected Positive) | Panel: % Correct Negative (Expected Negative) | Panel: % Correct Positive (Expected Positive) |
|---|---|---|---|---|---|
| AMP 1000 | -100% (0 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A |
| -75% (250 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| -50% (500 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| -25% (750 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| Cut-off (1000 ng/mL) | 20-25% (19/75-25/75) Negative | 75-80% (50/75-56/75) Positive | 16-21% (12/75-16/75) Negative | 79-84% (59/75-63/75) Positive | |
| +25% (1250 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +50% (1500 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +75% (1750 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +100% (2000 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| COC 300 | -100% (0 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A |
| -75% (75 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| -50% (150 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| -25% (225 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| Cut-off (300 ng/mL) | 17-21% (13/75-16/75) Negative | 79-83% (59/75-62/75) Positive | 20-21% (15/75-16/75) Negative | 79-80% (59/75-60/75) Positive | |
| +25% (375 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +50% (450 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +75% (525 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +100% (600 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| MET 1000 | -100% (0 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A |
| -75% (250 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| -50% (500 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| -25% (750 ng/mL) | 100% (75/75) | N/A | 100% (75/75) | N/A | |
| Cut-off (1000 ng/mL) | 19-27% (14/75-20/75) Negative | 73-81% (55/75-61/75) Positive | 16-21% (12/75-16/75) Negative | 79-84% (59/75-63/75) Positive | |
| +25% (1250 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +50% (1500 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +75% (1750 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) | |
| +100% (2000 ng/mL) | N/A | 100% (75/75) | N/A | 100% (75/75) |
Lay User Study Performance (Cup & Panel combined, n=20 per concentration level per drug):
| Drug (Cutoff ng/mL) | Concentration (% of Cut-off) | % Correct Negative | % Correct Positive |
|---|---|---|---|
| AMP 500 | -100%, -75%, -50% | 100% | N/A |
| -25% | 95% | 5% | |
| +25% | 10% | 90% | |
| +50%, +75% | N/A | 100% | |
| AMP 1000 | -100%, -75%, -50% | 100% | N/A |
| -25% | 90% | 10% | |
| +25% | 5-10% | 90-95% | |
| +50%, +75% | N/A | 100% | |
| COC 150 | -100%, -75%, -50% | 100% | N/A |
| -25% | 90% | 10% | |
| +25% | 10% | 90% | |
| +50%, +75% | N/A | 100% | |
| COC 300 | -100%, -75%, -50% | 100% | N/A |
| -25% | 90% | 10% | |
| +25% | 5-10% | 90-95% | |
| +50%, +75% | N/A | 100% | |
| MET 500 | -100%, -75%, -50% | 100% | N/A |
| -25% | 90% | 10% | |
| +25% | 10% | 90% | |
| +50%, +75% | N/A | 100% | |
| MET 1000 | -100%, -75%, -50% | 100% | N/A |
| -25% | 95% | 5% | |
| +25% | 5% | 95% | |
| +50%, +75% | N/A | 100% |
(Note: The table only includes performance for the new analytes (AMP 1000, COC 300, MET 1000) for precision, and for all listed analytes in the lay user study, which implicitly includes the other cut-off values for AMP, COC, and MET, as well as the other drugs reported in K182738.)
2. Sample Size Used for the Test Set and Data Provenance
Precision Studies (Laboratory Testing):
- Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 9 concentration levels were tested. For each concentration, 5 replicates were performed per day for 5 days, across 3 lots.
- This equates to: 9 concentrations * 5 replicates/day * 5 days * 3 lots = 675 total tests per analyte for the precision study using spiked urine samples.
- Data Provenance: The document states, "These samples were prepared by spiking drug in negative urine samples." This indicates the data is from prospective, laboratory-controlled experiments using spiked urine samples. The country of origin for the samples themselves is not explicitly stated beyond being "negative urine samples," but the submitting company is Hangzhou Alltest Biotech Co.,Ltd. in China, suggesting the studies likely occurred there or with materials sourced globally.
Comparison Studies (Clinical Samples):
- Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 80 unaltered clinical urine samples were used (40 negative and 40 positive).
- This totals 80 samples per analyte (Cup and Panel results are reported on the same sample set).
- Data Provenance: The document states, "unaltered clinical samples." This suggests these were retrospective clinical samples. The country of origin is not specified.
Lay User Study:
- Sample Size: 560 lay persons participated. Urine samples were prepared at 7 concentration levels (negative, +/-25%, +/-50%, +/-75%, +100% of cut-off) for each drug. Each participant was provided with 1 blind labeled sample and a device.
- For each of the approximately 14 drugs/cut-off concentrations evaluated, there were 7 concentration levels. Each concentration level had 20 tests (Agreement (%) is based on 20 total for each row). So, at minimum, 14 drugs * 7 concentrations * 20 tests/concentration = 1960 total tests were performed by lay users, distributed across the 560 participants.
- Data Provenance: The samples were "prepared by spiking drugs into drug free-pooled urine specimens," indicating prospective, laboratory-controlled experiments using spiked urine samples. The study was performed at "three intended user sites" but the country/region is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Precision Studies and Lay User Studies:
- Ground Truth Establishment: The ground truth for these studies was established by spiking known concentrations of drugs into negative urine samples and confirming them by LC/MS. This is a chemical/analytical method, not expert opinion.
- Number of Experts & Qualifications: Not applicable, as the ground truth was determined analytically.
Comparison Studies (Clinical Samples):
- Ground Truth Establishment: The ground truth for the clinical samples was established using LC/MS (Liquid Chromatography-Mass Spectrometry), which is the recommended confirmatory method as stated in the Indications for Use.
- Number of Experts & Qualifications: Not applicable, as the ground truth was determined via a definitive analytical method, not human expert consensus. "Three laboratory assistants" ran the device tests, but they were not establishing the ground truth.
4. Adjudication Method for the Test Set
Precision Studies and Lay User Studies:
- Adjudication Method: Not applicable. The ground truth was based on known spiked concentrations confirmed by LC/MS. The device's result was compared directly to this analytical ground truth.
Comparison Studies (Clinical Samples):
- Adjudication Method: Not explicitly described in terms of human adjudication. However, the document states: "The samples were blind labeled and compared to LC/MS results." This implies a direct comparison against a definitive analytical method (LC/MS) for ground truth, rather than an adjudication process involving multiple human interpretations of the ground truth. The "Discordant Results" tables show discrepancies between the viewer (device interpreter) results and the LC/MS result, indicating the LC/MS was the adjudicating method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a typical MRMC comparative effectiveness study was not explicitly described in the context of human readers improving with AI vs. without AI assistance.
- The document describes a "Comparison Studies" section, but this compares the device's performance to LC/MS results. It also mentions three "Viewer" (likely laboratory assistants or technicians) evaluating the device results against LC/MS, but it's not a study about human readers improving with AI assistance. It's a study of the device's performance when interpreted by human users against a gold standard.
- The device itself is a rapid test cup/panel, not an AI software.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable. The device is an immunochromatographic assay (a physical test strip/cup), not an algorithm or AI software. Its performance inherently involves human-in-the-loop for result interpretation (reading the lines). The "Precision" study and the "Comparison Studies" evaluate the device's standalone analytical performance, but its practical use and reported performance include human interpretation of its visual output. The "Lay User Study" specifically evaluates performance with human-in-the-loop (lay users interpreting the results).
7. The Type of Ground Truth Used
- Precision Studies & Lay User Studies: The ground truth was established by spiking known concentrations of drugs into drug-free urine samples, with these concentrations confirmed by LC/MS. This is an analytically derived ground truth.
- Comparison Studies (Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a definitive analytical gold standard for drug detection.
8. The Sample Size for the Training Set
The document does not describe the development of an algorithm or AI model that would require a "training set." This device is a rapid diagnostic test based on immunochromatography. Therefore, the concept of a training set as used in machine learning is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no mention of a training set for an algorithm or AI model. The device operates on chemical and immunological principles, not machine learning.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).