(211 days)
Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
For over-the-counter use.
Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
For prescription use only.
The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup. Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
The provided document is a 510(k) Summary for the Shanghai Accurature Diagnostics Co., Ltd. Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card. It describes the device's indications for use, its substantial equivalence to a predicate device, and performance data from various studies.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" for precision or agreement. However, it indicates a "qualified" result for percentage agreement among positives and negatives in the comparison study (Section 10.1). For precision (Section 10.7), it states a cutoff coincidence rate of 79% (which is >55%) and a ±25% cutoff coincidence rate of 88% (which is >84%), both deemed "qualified." For the lay user study, the percentages of agreement for specific concentrations are presented. Given that these devices are screening tools, the implicit acceptance criteria would be high agreement rates (ideally 100% or very close) for negative and strongly positive samples, and reasonable agreement around the cutoff concentrations.
Here's a summary of the reported performance from the comparison study, which appears to be the primary study for establishing initial performance characteristics:
| Drug | Device | Agreement among positives | Agreement among negatives | Reported Performance (Agreement) |
|---|---|---|---|---|
| Amphetamine | Cup | 98.3% | 100.0% | Qualified |
| Amphetamine | Card | 98.3% | 100.0% | Qualified |
| Secobarbital | Cup | 98.3% | 100.0% | Qualified |
| Secobarbital | Card | 100.0% | 100.0% | Qualified |
| Buprenorphine | Cup | 98.3% | 100.0% | Qualified |
| Buprenorphine | Card | 100.0% | 100.0% | Qualified |
| Oxazepam | Cup | 98.3% | 100.0% | Qualified |
| Oxazepam | Card | 98.3% | 100.0% | Qualified |
| Cocaine | Cup | 97.5% | 100.0% | Qualified |
| Cocaine | Card | 98.3% | 100.0% | Qualified |
| Methylenedioxy-methamphetamine | Cup | 95.8% | 100.0% | Qualified |
| Methylenedioxy-methamphetamine | Card | 98.3% | 100.0% | Qualified |
| Methamphetamine | Cup | 95.8% | 100.0% | Qualified |
| Methamphetamine | Card | 99.2% | 100.0% | Qualified |
| Morphine | Cup | 97.5% | 100.0% | Qualified |
| Morphine | Card | 99.2% | 100.0% | Qualified |
| Methadone | Cup | 97.5% | 100.0% | Qualified |
| Methadone | Card | 97.5% | 100.0% | Qualified |
| Oxycodone | Cup | 99.2% | 100.0% | Qualified |
| Oxycodone | Card | 96.7% | 100.0% | Qualified |
| Phencyclidine | Cup | 95.8% | 100.0% | Qualified |
| Phencyclidine | Card | 99.2% | 100.0% | Qualified |
| Marijuana | Cup | 99.2% | 100.0% | Qualified |
| Marijuana | Card | 99.2% | 100.0% | Qualified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Comparison Study (Section 10.1): The sample size is not explicitly stated as a single number. The tables show "agreement among positives" and "agreement among negatives" for each drug with percentages. While not directly stated, the implication is that a sufficient number of samples were tested to generate these percentages. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
- Precision Study (Section 10.7): For each drug, the study tested "drug free," "-75%Cut off," "-50%Cut off," "+100% cutoff," "+75%Cut off," and "+50%Cut off" samples. The number of samples per concentration is not explicitly given, but the results for "-75%Cut off," "-50%Cut off," "drug free" samples were all negative, and "+100% cutoff," "+75%Cut off," "+50%Cut off" samples were all positive. The specific number of samples at the cutoff and ±25% cutoff concentrations that led to the "79%(>55%)" and "88%(>84%)" coincidence rates, respectively, is not provided.
- Lay User Study (Section 10.8):
- Test Cup: 603 laypersons. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff levels. Each layperson was given 1 blind-labeled sample.
- Test Dip Card: 300 laypersons. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff levels. Each layperson was given 1 blind-labeled sample.
- Data Provenance: Not specified (e.g., country of origin or retrospective/prospective). However, the study involved "three intended user sites" and "diverse educational and professional backgrounds."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Lay User Study (Section 10.8): The ground truth for the lay user study was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly reliable analytical chemical method. This is not dependent on human expert interpretation of the test results themselves, but rather on instrument analysis. The samples were "spiking drug free-pooled urine specimens" with known concentrations, and these concentrations were "confirmed by LC/MS." Therefore, the ground truth is analytical, not expert consensus on the device's outcome.
- For other studies like the Comparison Study and Precision, the method for establishing ground truth isn't explicitly detailed, but generally, for drug screening devices, analytical methods (like GC/MS or LC/MS) are considered the gold standard for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information on adjudication methods such as 2+1 or 3+1 is provided. The studies appear to rely on objective measures (percentages of agreement with an assumed or analytically confirmed truth). For the lay user study, the ground truth was analytical (LC/MS), eliminating the need for reader adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable to the provided document. The device is a lateral flow immunochromatographic assay (a rapid drug test), not an AI-powered diagnostic system or an imaging modality that would involve human readers interpreting images. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical diagnostic kit (test cup/dip card) that provides a qualitative result (presence or absence of a line). It is not an algorithm, and its performance is inherently "standalone" in that it produces a result without further computational analysis. The "human-in-the-loop" aspect for this device involves a person performing the test and visually interpreting the lines, particularly in the over-the-counter (OTC) use case. The lay user study evaluates this "human-in-the-loop" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The primary type of ground truth used, particularly for the lay user study, was analytical chemical confirmation, specifically LC/MS (Liquid Chromatography-Mass Spectrometry). For the precision study, samples were prepared at specific concentrations relative to the cutoff, implying a known, analytically verified concentration as the ground truth. This is considered a highly objective and accurate method for determining the presence and concentration of substances.
8. The sample size for the training set
- The document describes performance studies, cross-reactivity, interference, and a lay user study. It does not mention a "training set" in the context of machine learning or algorithm development. The device is a lateral flow immunoassay, which does not involve a training set as would be found in AI/ML applications. The studies described are for validation of the physical test device.
9. How the ground truth for the training set was established
- As there is no "training set" for this type of device, this question is not applicable. The underlying principles of the immunoassay are based on chemical reactions, not on data learned from a training set.
§ 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).