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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.

Ask a specific question about this device

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 listed. The test may yield positive results for the prescription drugs Buprenorphine, 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 listed. 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 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.

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 text describes the performance characteristics of the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. The document details analytical performance (precision, linearity, stability, interference, specificity, effect of specific gravity and pH) and comparison studies (method comparison and lay-user study).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each analytical performance characteristic are implicitly defined by the successful results reported in the study. The study aims to demonstrate that the device performs as expected according to its intended use and analytical specifications.

• Precision:

  • Acceptance Criteria for -100% to -25% Cut-off: All samples should test negative.
  • Acceptance Criteria for +25% to +100% Cut-off: All samples should test positive.
  • Acceptance Criteria for Cut-off (nominal concentration): Approximately 50% positive and 50% negative results (reflecting the nature of the cut-off).
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Dip Card (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 24-/26+, 25-/25+, 26-/24+ (Split between positive and negative, as expected)
    • Cup (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 27-/23+, 24-/26+, 26-/24+ (Split between positive and negative, as expected)

• Interference:

  • Acceptance Criteria: No interference from common physiological or pathological substances at specified concentrations.
  • Reported Device Performance: No interference observed for a comprehensive list of compounds at 100ug/mL (except albumin at 100mg/dL and ethanol at 1% volume).

• Specificity (Cross-Reactivity):

  • Acceptance Criteria: Related compounds should either not cross-react or cross-react at concentrations significantly higher than the cut-off, as defined by medical relevance.
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Methadone: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • EMDP: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • Doxylamine, Disopyramide, LAAM HCl, Alpha Methadol: Positive at >100,000 ng/mL (

Ask a specific question about this device

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamine, Phencyclidine, Methadone, Nortriotyline and d-Propoxyphene 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. 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. GCMS 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 immunichromatographic assays for qualitative and simultaneous detection of Amphetanine, Oxazepam, Methamphetamine, Morghine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

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

The test may yield positive results for the prescription drugs Buprenorphine. Oxazenam, 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 method must be used in order to obtain a confirmed analytical result. GCMS 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 and Propoxyphene (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 performance characteristics and studies for the SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section. However, the performance data presented implies a very high standard for accuracy, particularly around the established cutoff concentrations. The "precision" studies demonstrate the device's ability to consistently produce correct results for samples at varying concentrations relative to the cutoff. The "comparison studies" compare the device's qualitative results to a quantitative gold standard (LC/MS) to establish concordance. The "lay-user study" assesses the ability of untrained individuals to correctly use and interpret the device.

Based on the provided data, the implied acceptance criteria for qualitative immunoassay devices for drug testing would typically be:

• 100% agreement for samples significantly below the cutoff (Negative).
• 100% agreement for samples significantly above the cutoff (Positive).
• High percentage agreement for samples near the cutoff (typically >90%).

For the Precision Study (Analytical Performance - "Test Set" Data):

The table below summarizes the reported performance for Methylenedioxymethamphetamine (MDMA), Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, and Propoxyphene (results from 3 lots, 50 tests per concentration per lot, per device type). The format is (Number of Negative Results)/(Number of Positive Results).

For the Lay-user Study:

The acceptance criteria for the lay-user study would typically be a high percentage of correct results, especially for samples clearly negative or positive, and a reasonable proportion around the cutoff. The document shows the "percentage of correct results (%)" for each concentration level. The implied acceptance criteria for OTC urine drug screens are usually very high concordance (e.g., >90%) with the ground truth for samples away from the cutoff, and some level of agreement for near-cutoff samples (where variability is expected). The device performance meets these generally implied high standards, especially for samples clearly below or above the cutoff (100% for most categories). For samples near +/-25% of cutoff, the accuracy ranges from 85-95%, which is typical for qualitative tests and acceptable for over-the-counter use where confirmation is recommended for positive results.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies (Test Set):
  • For each drug, device type (Dip Card/Cup), and each of the 9 concentration levels: 50 tests were performed per concentration.
  • This was repeated for 3 different lots for each device type.
  • Therefore, for a single drug and device type, the test set size for precision was: 9 concentrations * 50 tests/concentration * 3 lots = 1350 tests.
  • Data Provenance: The samples were prepared by "spiking drug in negative samples" and confirmed by LC/MS. This suggests controlled, prospective laboratory-prepared samples rather than retrospective clinical samples from specific countries. The testing was "in-house."
• Comparison Studies (Test Set):
  • For each drug and device type (Dip Card/Cup): 80 unaltered clinical samples (40 negative and 40 positive) were used.
  • Data Provenance: "unaltered clinical samples." The document does not specify the country of origin, but given the manufacturer (China) and submission to US FDA, the samples could be from various global sources or acquired for the study. It's a retrospective analysis against independently confirmed samples.
• Lay-user Study (Test Set):
  • For each device format (presumably Dip Card and Cup, though only combined results are shown in the given table): 300 lay persons participated.
  • The total number of samples processed for each drug across the different concentration levels in the lay-user study tables is: 20 + 20 + 160 + 20 + 20 + 40 + 20 = 300 samples. (It seems 300 samples were tested for each drug type, probably with each of the 300 lay users testing one sample)
  • 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." These were laboratory-prepared samples. The study involved "three intended user sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Precision Studies: Ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a definitive quantitative analytical method. It's an instrumental method, so human "experts" in interpretation are typically not specified in the same way as for imaging or clinical diagnosis. The samples were "blindly labeled by the person who prepared the samples," which indicates blinding to the LC/MS results during the device testing.
• Comparison Studies: Ground truth was established by LC/MS results. The document states, "The samples were blind labeled and compared to LC/MS results." These are definitive chemical analysis results.
• Lay-user Study: Ground truth for the samples was established by LC/MS confirmation of the spiked drug concentrations.

4. Adjudication Method for the Test Set

• Precision Studies: No explicit human adjudication method mentioned, as the device results are quantitative categories (positive/negative) and compared to definitive LC/MS values. The results are reported as counts (e.g., 25-/25+).
• Comparison Studies: The device results were read by "three laboratory assistants." For discordant results, the individual viewer's result is listed against the LC/MS truth, but no specific human adjudication process (e.g., 2+1 majority voting) is described for resolving discrepancies among the assistants or between the assistants and LC/MS. The LC/MS is the definitive ground truth here.
• Lay-user Study: The results are presented as aggregated counts of positive/negative readings by the lay users compared to the known ground truth (LC/MS confirmed concentrations). No human adjudication process is mentioned among the lay users.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret images or complex data, and the AI serves as an aid.
• This device is a qualitative, over-the-counter urine drug test. Its performance is evaluated against chemical analytical ground truth, and its usability is assessed with lay users, not by evaluating how it assists expert readers.

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

• This device is a physical, qualitative immunoassay test kit, not a standalone algorithm/AI for analysis. The "performance" of the device itself (the reaction on the dip card/cup) is evaluated.
• However, the Comparison Studies and Precision Studies could be considered the "standalone" performance of the device when read by trained laboratory personnel (3 laboratory assistants), as it's the device's output itself being compared to LC/MS.
• The Lay-user study evaluates the device performance when interpreted by the intended "human-in-the-loop" (a lay user).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used for all performance studies (Precision, Comparison, Lay-user) is quantitative chemical analysis by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted method for confirming drug concentrations in urine.
• For the precision and lay-user studies, urine samples were spiked with known concentrations of drugs, and these concentrations were confirmed by LC/MS.
• For the comparison studies, "unaltered clinical samples" were used, with LC/MS providing the definitive truth for the presence and concentration of drugs.

8. The Sample Size for the Training Set

• This document describes premarket notification (510(k)) for a drug test kit, which is a physical diagnostic device based on immunochromatography, not an AI/Machine Learning algorithm.
• Therefore, there is no "training set" in the context of machine learning model development. The device's performance relies on its physical and chemical design, not on a trained algorithm.

9. How the Ground Truth for the Training Set Was Established

• As there is no AI/ML algorithm or training set, this question is not applicable.

Ask a specific question about this device

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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