(209 days)
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 500ng/mL |
| Morphine | 300ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine 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, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The tests are intended for over-the-counter use.
SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 500ng/mL |
| Morphine | 300ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The tests are intended for over-the-counter use.
The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
The provided document describes the performance characteristics and studies for the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. It does not describe an AI/ML device but rather an in-vitro diagnostic device (IVD) for drug screening. Therefore, several of the requested categories for AI/ML device evaluation are not applicable (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set).
Here's the information extracted from the document, tailored to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for qualitative drug tests are typically defined by precision around the cutoff concentration. The device is expected to consistently classify samples below the cutoff as negative and above the cutoff as positive. For samples near the cutoff, some variability in classification is expected.
| Test Parameter / Drug (Cut-off) | Acceptance Criteria (Implicit from study design) | Reported Device Performance (Precision Study - Example for Dip Card, Lot 1) |
|---|---|---|
| Precision | Samples +25% Cut-off: 100% positive calls. Samples within +/-25% of Cut-off: Expected variability. | Amphetamine 500: |
| -100% Cut-off: 50-/0+ (100% negative) | ||
| -75% Cut-off: 50-/0+ (100% negative) | ||
| -50% Cut-off: 50-/0+ (100% negative) | ||
| -25% Cut-off: 50-/0+ (100% negative) | ||
| Cut-off: 24-/26+ (48% negative, 52% positive) | ||
| +25% Cut-off: 50+/0- (100% positive) | ||
| +50% Cut-off: 50+/0- (100% positive) | ||
| +75% Cut-off: 50+/0- (100% positive) | ||
| +100% Cut-off: 50+/0- (100% positive) | ||
| Cocaine 150: | ||
| -100% Cut-off: 50-/0+ (100% negative) | ||
| -75% Cut-off: 50-/0+ (100% negative) | ||
| -50% Cut-off: 50-/0+ (100% negative) | ||
| -25% Cut-off: 50-/0+ (100% negative) | ||
| Cut-off: 24-/26+ (48% negative, 52% positive) | ||
| +25% Cut-off: 50+/0- (100% positive) | ||
| +50% Cut-off: 50+/0- (100% positive) | ||
| +75% Cut-off: 50+/0- (100% positive) | ||
| +100% Cut-off: 50+/0- (100% positive) | ||
| Methamphetamine 500: | ||
| -100% Cut-off: 50-/0+ (100% negative) | ||
| -75% Cut-off: 50-/0+ (100% negative) | ||
| -50% Cut-off: 50-/0+ (100% negative) | ||
| -25% Cut-off: 50-/0+ (100% negative) | ||
| Cut-off: 24-/26+ (48% negative, 52% positive) | ||
| +25% Cut-off: 50+/0- (100% positive) | ||
| +50% Cut-off: 50+/0- (100% positive) | ||
| +75% Cut-off: 50+/0- (100% positive) | ||
| +100% Cut-off: 50+/0- (100% positive) | ||
| Morphine 300: | ||
| -100% Cut-off: 50-/0+ (100% negative) | ||
| -75% Cut-off: 50-/0+ (100% negative) | ||
| -50% Cut-off: 50-/0+ (100% negative) | ||
| -25% Cut-off: 50-/0+ (100% negative) | ||
| Cut-off: 24-/26+ (48% negative, 52% positive) | ||
| +25% Cut-off: 50+/0- (100% positive) | ||
| +50% Cut-off: 50+/0- (100% positive) | ||
| +75% Cut-off: 50+/0- (100% positive) | ||
| +100% Cut-off: 50+/0- (100% positive) | ||
| Lay-User Study (Accuracy) | For samples far from cutoff (e.g., -50% and +50%), approximately 100% correct results. For samples near cutoff (e.g., -25% and +25%), high accuracy (e.g., >90%). | AMP500: |
| -50% Cutoff: 100% correct (0 Pos, 170 Neg) | ||
| +50% Cutoff: 100% correct (40 Pos, 0 Neg) | ||
| -25% Cutoff: 90% correct (2 Pos, 18 Neg) | ||
| +25% Cutoff: 95% correct (19 Pos, 1 Neg) | ||
| (Similar results reported for COC150, THC, BAR, BZO, MET500, MTD, MOP300, MDMA, OXY, BUP, PCP, TCA, PPX, EDDP) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Precision Study (Test Set):
- For each drug (Amphetamine, Cocaine, Methamphetamine, Morphine), 9 concentrations were tested around the cutoff (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100%).
- For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device. This equates to 50 replicates per concentration per lot, totaling 450 tests per lot per drug.
- Total replicates for 4 drugs (AMP, COC, MET, MOP): 9 concentrations x 50 replicates/concentration x 3 lots = 1350 tests per drug. (Some data for other drugs were referenced from prior 510(k)s: K182654, K181968, K153646, K201120).
- Data Provenance: The document states "in-house" for comparison studies and "urine samples were prepared by spiking drug in negative samples" for precision studies. This suggests a controlled laboratory setting (likely prospective, artificial samples). The document does not specify the country of origin of the data.
-
Method Comparison Study (Clinical/Test Set):
- 80 "unaltered clinical samples" were used for each drug. These samples were split into categories: 10 negative, 10 low negative, 20 near cutoff negative, 20 near cutoff positive, 20 high positive for each drug.
- Total samples per device type (Dip Card or Cup) for 4 drugs mentioned: 80 samples x 4 drugs = 320 samples per device type.
- Data Provenance: "in-house" and "unaltered clinical samples," implying real-world samples but processed within the manufacturer's lab. The document does not specify the country of origin or whether these clinical samples were retrospective or prospectively collected for the study.
-
Lay-User Study (Test Set):
- 310 lay persons participated for each device format (Dip Card and Cup).
- Urine samples were prepared at 7 concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff.
- Total samples: For each drug, the number of samples varied across concentrations. For example, for AMP500, 20 samples at -100% cutoff, 20 at -75%, 170 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%. This totals 310 samples per drug per device format.
- Data Provenance: "at three intended user sites." Samples were "prepared by spiking drugs into drug free-pooled urine specimens," making them artificial but intended to mimic a range of concentrations. This suggests a prospective study design, mimicking real-world use conditions but with controlled samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Precision Study: Ground truth was established by preparing urine samples with known drug concentrations confirmed by LC/MS. No human experts were involved in establishing ground truth, as it was an analytical study.
- Method Comparison Study: The ground truth for clinical samples was established by LC/MS results. No mention of human experts for ground truth.
- Lay-User Study: Ground truth was established by LC/MS results of the prepared spiked urine samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device is a qualitative diagnostic test read directly by users, not an AI/ML imaging device requiring expert adjudication. In the method comparison study, three laboratory assistants "ran" the samples, implying they performed the test, but the ground truth was LC/MS, not their consensus.
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
- Not applicable. This is not an AI/ML device, and no MRMC study comparing human readers with and without AI assistance was mentioned. The lay-user study evaluated the device's performance with lay users, not an "AI assistance" scenario.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical, lateral flow immunochromatographic assay. Its performance inherently involves a human interpreting the result line, even if it's a simple positive/negative visual interpretation. It is not an algorithm-only device. The precision and method comparison studies evaluate the device's analytical performance, which is its inherent "standalone" capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- LC/MS (Liquid Chromatography-Mass Spectrometry) was used as the ground truth method to confirm drug concentrations in both spiked samples (for precision and lay-user studies) and clinical samples (for method comparison studies). This is a highly accurate and quantitative analytical method.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on immunoassay principles.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/ML device.
§ 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).