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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:

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:

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.

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.

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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:

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 Oxazepam and Secobarbital 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 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, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Cup combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Oxazepam and Secobarbital 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. 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, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone (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 document describes the SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup devices, which are qualitative lateral flow immunochromatographic assays for detecting various drugs in human urine.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of a minimum performance threshold (e.g., "sensitivity must be >90%"). Instead, it presents the results of precision, specificity, linearity, stability, interference, and comparison studies, implying that the observed performance across these studies is considered acceptable for substantial equivalence. For the qualitative tests, the key performance indicator is the ability to correctly identify samples both above and below the cut-off concentrations.

Below is a summary of the reported device performance for selected drugs based on "Precision" and "Lay-user study" data. The "Precision" study shows how consistently the device performs near the cut-off, while the "Lay-user study" assesses the device's accuracy when used by the intended over-the-counter users.

Acceptance Criteria (Implied for consistency and accuracy related to cut-off)

• Precision: High agreement (ideally 100% negative/positive) for samples far from the cutoff (e.g., -100%, -75%, +75%, +100% cutoff). Some variability (mixed positive/negative results) is expected and acceptable near the cutoff (e.g., -25%, cutoff, +25%).
• Lay-user Performance (Percentage of correct results): High percentage of correct results, especially for samples significantly above or below the cutoff. Some deviation might be acceptable near the cutoff.

Reported Device Performance (Excerpt for Secobarbital Dip Card and for all drugs in Lay-user study)

Precision Study - Secobarbital Dip Card (Illustrative Example from document, similar patterns for other drugs)

Interpretation for Precision (e.g., Secobarbital Dip Card):

• For samples far below the cutoff (-100%, -75%, -50%, -25%), all 50 tests consistently showed negative results (50-/0+), indicating perfect agreement for negative samples sufficiently below the cutoff.
• For samples far above the cutoff (+25%, +50%, +75%, +100%), all 50 tests consistently showed positive results (50+/0-), indicating perfect agreement for positive samples sufficiently above the cutoff.
• At the exact cutoff, there was an expected mix of positive and negative results (e.g., 25-/25+, 26-/24+), demonstrating the device's performance around the critical concentration.

Lay-user Study - Percentage of Correct Results (Summary across drugs for Dip Card)

Interpretation for Lay-user Study:
The lay-user study for both Dip Card and Cup formats consistently shows 100% correct results for samples well above (+50%, +75%) and well below (-50%, -75%, -100%) the cutoff. Near the cutoff point (-25% and +25%), the percentage of correct results typically drops to between 85% and 95%, which is expected given the concentrations are close to the detection threshold. The study indicates the devices perform as intended for over-the-counter use.

2. Sample size used for the test set and the data provenance

• Precision Study: For each drug and each device type (Dip Card/Cup), the samples were prepared at 9 different concentrations relative to the cut-off (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100%). For each concentration, tests were performed "two runs per day for 25 days per device in a randomized order." This implies a total of 50 tests per concentration per drug per device, for each of the three lots.
  • Example for Secobarbital Dip Card: 9 concentrations * 50 tests/concentration * 3 lots = 1350 test results.
  • Data Provenance: "These samples were prepared by spiking drug in negative samples." The document specifies these are "spiked" samples into "negative samples" (presumably drug-free urine), and concentrations were confirmed by LC/MS. This suggests laboratory-controlled samples (retrospective fabrication) rather than patient-derived clinical samples.
• Comparison Studies (Lab Assistant/Clinical Performance): For each drug, "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug."
  • This means 80 clinical samples per drug were used.
  • Data Provenance: "unaltered clinical samples." The document states this was "performed in-house," but does not specify the country of origin. Given the submitter is Safecare Biotech (Hangzhou) Co. Ltd. from China, the in-house clinical samples likely originated from China. The samples were compared to LC/MS results.
• Lay-user Study: "A lay user study was performed at three intended user sites with 240 lay persons for each device format."
  • The test set comprised urine samples prepared at 7 different concentrations relative to the cut-off (negative, +/-75%, +/-50%, +/-25% of the cutoff). The document indicates for each concentration, approximately 20 to 100 samples were tested for each drug (e.g., 20 at -100% cutoff, 100 at -50% cutoff, 40 at +50% cutoff, totaling around 20 * 5 + 100 * 2 = 300 test results per drug).
  • Data Provenance: "Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." Concentrations confirmed by LC/MS. This implies laboratory-controlled spiked samples, similar to the precision study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Precision Studies & Lay-user Study: The ground truth (drug concentration) was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly accurate analytical method. The document does not specify human experts for establishing ground truth for these studies, as the LC/MS directly provides quantitative measurements.
• Comparison Studies (Lab Assistant/Clinical Performance): The ground truth for the "unaltered clinical samples" was established by LC/MS results. The study mentions "three laboratory assistants" who "ran" the tests and "compared to LC/MS results," but these assistants are the operators of the device under test, not the ground truth experts.

4. Adjudication method for the test set

• Precision Studies & Lay-user Study: The ground truth was based on objective analytical measurements (LC/MS). There was no human "adjudication" in the sense of reconciling differing expert opinions. The comparison was directly between the device's qualitative result and the known quantitative drug concentration relative to the cut-off.
• Comparison Studies (Lab Assistant/Clinical Performance): The document does not describe an explicit adjudication method. The results from the device, interpreted by "three laboratory assistants," were directly compared to the LC/MS results, which served as the gold standard. Discordant results are individually reported (e.g., Viewer A found Positive, LC/MS was 289 ng/mL), but no adjudication of discrepant viewer readings against each other or a higher authority is mentioned. Each viewer's interpretation was compared against the LC/MS.

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 device is a rapid diagnostic test (lateral flow immunochromatographic assay), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or described. The "readers" in the "Comparison Studies" are "three laboratory assistants" interpreting the visual lines on the test.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a manual, visually interpreted lateral flow assay. It does not employ an algorithm for interpretation. The performance is inherently "standalone" in the sense that the device produces a visual result, but it requires human interpretation. The "Lay-user study" specifically assesses performance without expert human-in-the-loop, relying on typical users' interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used in all analytical and comparative studies (Precision, Comparison, Lay-user) was Liquid Chromatography-Mass Spectrometry (LC/MS) results. This is a gold standard analytical method for precise and accurate quantification of drug concentrations.
• For the comparison studies, "unaltered clinical samples" were used, and their status (positive/negative relative to cutoff) was determined by LC/MS.

8. The sample size for the training set

• The document does not describe any "training set." These are diagnostic devices that do not involve machine learning or AI models requiring a training phase for their interpretation logic. Their "training" is in their manufacturing process and the inherent biochemical reactions.

9. How the ground truth for the training set was established

• Not Applicable as there is no training set described for this type of device.

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