(88 days)
SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.
The provided document describes the acceptance criteria and study results for the SAFECARE Urine Test Amphetamine, Cocaine, and Marijuana devices.
Here's an organized summary of the information requested:
Acceptance Criteria and Device Performance Study
The SAFECARE Urine Test devices are qualitative tests for the detection of Amphetamine, Cocaine (Benzoylecgonine), and Marijuana (Cannabinoids) in human urine at specific cutoff concentrations. The study aims to demonstrate the device's accuracy and reliability through analytical performance and comparison studies.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%). However, the study design implicitly establishes acceptance criteria through its reported performance, which demonstrates consistent and accurate results around the cutoff concentrations. Given that this is a 510(k) submission and the conclusion states "acceptable performance characteristics" and "substantially equivalent to the predicate," the presented performance implicitly meets the FDA's requirements for substantial equivalence.
Interpreted Acceptance Criteria (Implicitly met by study results):
- Precision: Consistent results across different lots and repeated testing at various concentrations relative to the cutoff. For concentrations well below the cutoff (-100%, -75%, -50% cutoff), results should be consistently negative. For concentrations well above the cutoff (+50%, +75%, +100% cutoff), results should be consistently positive. At concentrations near the cutoff (-25%, cutoff, +25% cutoff), there should be an expected distribution of positive and negative results, demonstrating appropriate cutoff sensitivity.
- Cut-off Verification: All samples at and above +50% cut-off are positive, and all samples at and below -50% cut-off are negative.
- Interference/Specificity: No interference from common physiological substances or cross-reactivity from specified compounds at tested concentrations should lead to false positives/negatives at 25% above cutoff.
- Method Comparison: High agreement with GC/MS results for both negative and positive clinical samples. Low rates of discordant results, particularly for samples well below or well above the cutoff.
- Lay-user Performance: High percentages of correct results when performed by lay users, indicating ease of understanding and use. This is especially critical for over-the-counter devices.
Reported Device Performance (Excerpt for Amphetamine Dip Card - Precision Study):
| Drug | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
|---|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | Negative | 50 | 50 | 50 | 47 | 24 | 1 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 3 | 26 | 49 | 50 | 50 | 50 | |
| Lot 2 | Negative | 50 | 50 | 50 | 48 | 26 | 2 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 24 | 48 | 50 | 50 | 50 | |
| Lot 3 | Negative | 50 | 50 | 50 | 49 | 26 | 3 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 24 | 47 | 50 | 50 | 50 |
Self-correction made: The table in the document uses "50-/0+" format where 50- means 50 negative results and 0+ means 0 positive results. This was separated into two rows for clarity as "Negative" and "Positive".
Lay-User Performance (Excerpt for Amphetamine Cup):
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | No. of Positive | No. of Negative | The percentage of correct results (%) |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
2. Sample Size for the Test Set and Data Provenance
All test sets (precision, cut-off, interference, specificity, method comparison, and lay-user studies) appear to use data that is retrospective in nature, as samples were "prepared by spiking drug in negative samples" or "unaltered clinical samples" were "blind labeled and compared to GC/MS results". The provenance of the data is not explicitly stated as a country of origin but implies laboratory-prepared or collected clinical samples, likely within China where the manufacturer is located, or a contract lab.
Sample Sizes for Test Sets:
- Precision Study:
- For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
- 9 concentration levels (-100% to +100% of cut-off).
- Each concentration tested 50 times (2 runs per day for 25 days) for each of 3 lots.
- Total observations per drug/format: 9 concentrations * 50 tests/concentration * 3 lots = 1350 observations.
- For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
- Cut-off Verification Study:
- For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
- 5 concentration levels (-50%, -25%, cut-off, +25%, +50% of cut-off).
- Total samples: 150 samples (equally distributed across 5 concentrations, so 30 samples per concentration) tested using 3 different lots by 3 different operators.
- For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
- Interference/Specificity Studies:
- Urine samples (drug-free and spiked at +25% cut-off) tested for each interfering substance/cross-reactant compound. Number of tests per substance (e.g., 3 batches of each device for all formats) is not explicitly listed per substance but implied to be sufficient.
- Method Comparison Studies:
- For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
- 80 unaltered clinical samples (40 negative, 40 positive).
- Total samples per drug/format tested by 3 viewers: 80 samples * 3 viewers = 240 observations.
- For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
- Lay-user Study:
- For Amphetamine devices: 420 lay persons.
- For Cocaine devices: 420 lay persons.
- For Marijuana devices: 420 lay persons.
- Each person tested one blind labeled sample and a device.
- Sample concentrations used: 7 levels (-100% to +75% of cut-off), 20 samples per level. Total samples per drug: 7 concentrations * 20 samples/concentration = 140 samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For Analytical Performance (Precision, Cut-off, Interference, Specificity): The ground truth for spiked samples (negative samples spiked with known concentrations of drug) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the "preferred confirmatory method" and considered the gold standard for drug detection and quantification in toxicology. No "experts" in the sense of clinicians or radiologists were used. The document doesn't specify the qualifications of the personnel performing GC/MS.
- For Method Comparison Studies: The ground truth for the 80 unaltered clinical samples was established by GC/MS. These GC/MS results are the reference against which the device's performance was compared.
- For Lay-user Study: The ground truth for the prepared urine samples was confirmed by GC/MS.
4. Adjudication Method for the Test Set
- For Precision Studies: The testing was "performed two runs per day for 25 days" (total 50 tests per concentration per lot). The results are presented as counts of positive/negative. There is no mention of an adjudication method among multiple readers for these analytical studies.
- For Cut-off Verification Study: Testing was performed by "three different operators." There is no explicit adjudication method stated for these observations. The results are presented as all positive or all negative for certain concentration ranges, which implies agreement or a predefined interpretation across operators.
- For Method Comparison Studies: "Three different laboratory assistants" were the "operators" or "viewers" (referred to as Viewer A, B, C) who read the device results. The document lists discordant results individually for each viewer, indicating that results were compared viewer-by-viewer against GC/MS. There is no explicit multi-reader adjudication method (e.g., majority vote like 2+1 or 3+1) mentioned for reaching a consensus device result; rather, individual reader agreement with GC/MS is analyzed.
- For Lay-user Study: Lay persons independently read the results. The comparison is between the lay person's reading and the GC/MS ground truth. No adjudication among lay persons is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study performed a method comparison where individual "viewers" (laboratory assistants) read the devices and their results were compared to GC/MS. There is no comparison of human readers' performance with AI assistance versus without AI assistance, as these are rapid qualitative test devices, not AI-powered diagnostic algorithms.
6. Standalone (Algorithm Only) Performance
The SAFECARE Urine Test devices are immunochromatographic assays, not software algorithms or AI-driven systems. Their performance is inherently standalone (device-only, interpreted by a human user). The reported precision, cut-off, interference, specificity, and method comparison data represent the standalone performance of these physical tests.
7. Type of Ground Truth Used
- GC/MS (Gas Chromatography/Mass Spectrometry): This is consistently stated as the ground truth method for confirming drug concentrations in all performance studies (precision, cut-off, interference, specificity, method comparison, and lay-user studies). GC/MS is a highly accurate analytical method considered the gold standard for drug testing.
8. Sample Size for the Training Set
These devices are immunochromatographic assays, not machine learning or AI models, therefore they do not have a "training set" in the computational sense. Their development typically involves chemical and biological optimization, with analytical and clinical validation serving as the equivalent of performance evaluation.
9. How the Ground Truth for the Training Set Was Established
As noted above, these devices do not involve a training set as they are not AI/ML-based. The development of such diagnostic tests relies on established immunochemistry principles and rigorous analytical validation to ensure sensitivity, specificity, and accuracy against a gold standard like GC/MS.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).