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Shinetell Plus™ Digital Early Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Shinetell Plus™ Digital Early Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.

Shinetell Plus™ Digital Early Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.

Here's a breakdown of the acceptance criteria and study information for the Shinetell Plus™ Digital Early Pregnancy Test, based on the provided 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly state "acceptance criteria" as a separate, quantitative table. However, we can infer the acceptance criteria from the performance studies presented, particularly the sensitivity and agreement rates. The primary criterion is demonstrating a sensitivity of 10 mIU/mL and high agreement with professional results and the predicate device.

2. Sample Sizes and Data Provenance

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • Test Set Sample Size: For each hCG concentration (0, 3, 5, 7.5, 8, 10, 25, 50 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots, by 3 different operators. This sums to (8 concentrations * 10 replicates/day * 5 days * 3 lots) = 1200 tests for Midstream and another 1200 tests for Dip Testing.
  • Data Provenance: Not explicitly stated, but typically these are laboratory-controlled, prospective studies with spiked samples. The hCG standard is traceable to the 5th WHO.

• Specificity (Non-pregnant females):

  • Test Set Sample Size: 300 urine samples (100 from pre-menopausal, 100 from peri-menopausal, 100 from post-menopausal women).
  • Data Provenance: Not explicitly stated, but implies prospectively collected urine samples from healthy non-pregnant females.

• Method Comparison Study (vs. Predicate):

  • Test Set Sample Size: Urine samples from 200 women suspected to be pregnant in the early stage (

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AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture.

The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.

The AllTest Viral Transport Medium (VTM) device is comprised of a screw cap polypropylene tube filled with 3 mL VTM. The VTM tube is tightly closed with a polyethylene cap. The AllTest VTM contains Hank's Balanced Buffer solution (HBBS), proteins, sugar, and antimicrobials to provide stability to live viruses. The AllTest VTM also contains a pH indicator (phenol red) to provide a visual check on medium pH. The VTM appears clear and red in color. The packaging also includes a biohazard specimen bag.

The FDA 510(k) clearance letter for "AllTest Viral Transport Medium" describes the acceptance criteria and study that proves the device meets those criteria. Since this is a viral transport medium and not an AI/Software as a Medical Device (SaMD), the typical acceptance criteria for AI models (like sensitivity, specificity, AUC, etc.) and evaluation methods (such as MRMC studies, expert adjudication for ground truth) are not applicable. The device's performance is assessed based on its ability to maintain viral infectivity and nucleic acid stability over time and under different storage conditions.

Here's an analysis of the provided text, focusing on the relevant acceptance criteria and study details for this type of device:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria revolve around the stability and recovery of viral agents within the AllTest VTM.

Study Details

Given the nature of the device (viral transport medium), the typical elements of an AI/SaMD study are not present. However, we can extract analogous information where applicable.

1. Sample sizes used for the test set and the data provenance:

   • Shelf-life study: 15 tubes from each of three lots were tested at each time point for physical appearance and pH. 6 tubes were tested for microbial contamination.
   • Viral Recovery study: Viral recovery was assessed using three lots of media (3-month/new, 8-month/mid, and 12-month/old age lots). Contrived viral samples (pooled negative clinical matrix spiked with known concentration of virus) were used. These were then spiked onto swabs, transferred to VTM, and held at 4°C and 23-25°C for 0 and 48 hours. The specific number of replicates per condition is not explicitly stated beyond "serial 10-fold to a 96-well plate," but the overall methodology suggests controlled laboratory samples. Data provenance is implied to be laboratory-generated (contrived samples) rather than from specific countries or being retrospective/prospective clinical data.
   • Nucleic Acid Stability study:
     • LoD Determination: 20 replicates were tested at the preliminary LoD concentration (10 GCE/reaction) to confirm LoD.
     • Specimen Stability: Both clinical and contrived samples were used. Three lots of media (3-month/new, 8-month/mid, and 12-month/old age lots) were used. 50 µl of each sample was added to nasopharyngeal (NP) swab and transferred into VTM. Samples were stored at 4℃ and 23-25℃ for 0 and 48 hours. The specific number of clinical/contrived samples or replicates per condition is not explicitly stated. Data provenance includes both "clinical and contrived samples," suggesting some real clinical samples might have been used in addition to laboratory-prepared ones. This study appears to be laboratory-based testing.

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

   • Not applicable for this type of device. The "ground truth" for viral recovery and nucleic acid stability is established through quantitative laboratory measurements (TCID50 for viral recovery, Ct values for nucleic acid presence via PCR) against known input concentrations, not through expert consensus or interpretation of images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is a quantitative laboratory performance study, not a
     human-in-the-loop diagnostic accuracy study requiring adjudication.

4. 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 transport medium, not an AI/SaMD for diagnostic interpretation.

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

   • Not applicable. This is not an algorithm. The performance evaluation is for the physical medium itself.

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

   • For Viral Recovery: The "ground truth" or reference is the initial known concentration of the spiked virus (T=0 hour log10TCID50) to which the 48-hour recovery is compared. This is a quantitative laboratory reference.
   • For Nucleic Acid Stability: The "ground truth" or reference is the initial Ct value at T=0 hours from the spiked SARS-CoV-2 samples. This is a quantitative laboratory reference.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

Summary of the Study Design for AllTest Viral Transport Medium:

The studies conducted for the AllTest Viral Transport Medium are primarily laboratory-based performance studies designed to demonstrate the medium's ability to preserve the integrity of viral samples over specified timeframes and storage conditions. The methodology relies on established virological and molecular diagnostic techniques (viral culture/TCID50, PCR Ct values) using both contrived samples (known concentrations of viruses spiked into a matrix) and, for nucleic acid stability, also mentions the use of clinical samples. The "ground truth" is quantitative and established by the initial measurements of the spiked samples. The focus is on demonstrating stability and recovery rates rather than diagnostic accuracy or human performance.

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AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.

The provided document describes the analytical and user performance of the "AllTest Multi-Drug Rapid Urine Test Cup" and "AllTest Multi-Drug Urine Test Cup" for detecting various drugs in human urine.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or agreement. However, the performance studies demonstrate that the device is designed to correctly identify drug presence/absence relative to a defined cutoff concentration. For qualitative drug tests, a common expectation is high agreement rates for samples significantly above or below the cutoff, with some variability allowed for samples near the cutoff.

The reported device performance can be summarized from the precision and lay person studies. The precision studies show ideal performance at concentrations far from the cutoff (100% agreement), and expected variability (around 50% positive/negative calls) at the cutoff concentration. The lay person study similarly shows very high agreement (typically 90-100%) for samples adequately far from the cutoff concentration.

Since no explicit quantitative acceptance criteria are given in the provided text, the reported performance is presented in relation to the ideal behavior of a qualitative assay around its cutoff.

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AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of:

est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the performance characteristics demonstrated in the studies, particularly the agreement/precision at and around the cutoff concentrations, and the specificity. Since this is an in vitro diagnostic (IVD) device, the "performance" here refers to its accuracy in detecting the target analytes and its overall reliability in a diagnostic context. This is fundamentally about how well the device matches a known, established ground truth.

• Agreement at -100%, -75%, -50% Cutoff: Generally 100% negative agreement.
• Agreement at +50%, +75% Cutoff: Generally 100% positive agreement.
• Agreement at -25% and +25% Cutoff: Ranged from 85.0% to 95.0% negative/positive agreement, respectively, demonstrating expected variability around the cutoff.
  All participants found the instructions easy to understand and follow (Flesch-Kincaid Grade Level 7). |

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

• Precision/Reproducibility Study:

  • Sample Size: For each drug and each concentration (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff), tests were performed in 2 runs per day for 25 days, using 3 lots of test cups. This means for each concentration and drug, there were 50 tests per lot (2 runs/day * 25 days) and 150 tests across 3 lots.
  • Data Provenance: Urine samples spiked with target drugs into drug-free urine. The drug concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study, not from actual patients.

• Analytical Specificity/Interference Study:

  • Sample Size: Not explicitly stated as a total number, but drugs and interfering compounds were spiked into drug-free urine samples and tested using 3 lots of devices for each interference condition.
  • Data Provenance: Laboratory prepared urine samples (drug-free urine spiked with various compounds).

• Method Comparison Study:

  • Sample Size: 80 unaltered urine clinical samples (40 negative and 40 positive) for each drug.
  • Data Provenance: Unaltered clinical urine samples. The country of origin is not specified but it is an in-house study.

• Lay Person Study:

  • Sample Size: 280 lay persons.
  • Data Provenance: Urine samples prepared by spiking drug(s) into drug-free pooled urine specimens. The concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study designed to evaluate user comprehension and ease of use, not true clinical performance with patient samples.

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

• Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: Ground truth was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and standardized analytical method for drug concentration determination. No human experts were explicitly stated to establish this ground truth, as it's an objective chemical analysis.

• Method Comparison Study: Ground truth was established by LC-MS/MS. Similar to the above, this is an objective analytical method.

4. Adjudication Method for the Test Set

• For the Method Comparison Study, the device results were compared directly to the LC-MS/MS results. There is no mention of an adjudication process (e.g., 2+1, 3+1 expert review) for the ground truth itself, as LC-MS/MS is considered the definitive truth.
• For the Lay Person Study, the "ground truth" for the expected positive/negative call was based on the known spiked concentrations confirmed by LC-MS/MS. The participants' interpretations of the device results were then compared to this established truth. There was no adjudication of the lay person's reading, but rather an assessment of their accuracy against the known sample content.

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 device is a qualitative lateral flow immunochromatographic assay ("rapid test cup") for in vitro diagnostic use, intended for direct reading by a user (either professionals or lay persons). It does not involve AI or human readers interpreting complex images or data assisted by AI.
• The closest analogy is the "Lay Person Study," which assesses how well lay users can interpret the results without assistance on complex outputs, but there is no AI component.

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

• Yes, in spirit, the analytical performance studies (precision, specificity, stability) and the LC-MS/MS ground truth in the method comparison study represent "standalone" performance. The device itself (the immunochromatographic strip) is the "algorithm," and its chemical reactions are assessed according to established scientific principles, independent of human interpretation prior to result line formation.
• However, the final reading of the lines on the rapid test cup is still a human-in-the-loop step, even for laboratory personnel in the precision and method comparison studies, and especially for lay users in their study. The intent of these "rapid test" types of devices is precisely for direct human interpretation.

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

• The primary ground truth used across all analytical and method comparison studies was LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and quantitative laboratory method used for definitive drug detection and concentration measurement.

8. The Sample Size for the Training Set

• This submission describes a premarket notification (510(k)) for an in vitro diagnostic device. Unlike AI/ML devices, these types of products typically do not involve "training sets" in the machine learning sense.
• The manufacturing process, antibody selection, and assay design for these immunochromatographic tests are developed and refined through internal R&D, often using a range of samples and iterations. The document does not describe a formal 'training set' analogous to those used for AI algorithms. The data presented are for validation and verification of the finished device.

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

• As noted above, a "training set" in the AI/ML context is not applicable here. The development of the reagents and test design would have relied on standard laboratory practices for developing highly specific and sensitive immunoassays, with positive and negative controls and calibration against known concentrations, usually verified by gold-standard analytical methods like LC-MS/MS.

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AllTest Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinquish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Panel and AllTest Multi-Drug Rapid Urine Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a panel format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The provided document describes the acceptance criteria and study that proves the device (AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel) meets the acceptance criteria.

Note: This device is a qualitative in-vitro diagnostic test, not an AI-based medical device. Therefore, questions related to AI-specific aspects (e.g., number of experts for ground truth, MRMC study, training set, effect size of AI assistance) are not applicable to this submission. The "study" described focuses on analytical performance, method comparison (against a gold standard chemical method), and a lay-person usability study.

1. A table of acceptance criteria and the reported device performance

The document defines performance in terms of precision (reproducibility) and method comparison with LC-MS/MS. The acceptance criteria for these qualitative tests are implicitly demonstrated by the reported agreement with LC-MS/MS results, particularly around the cutoff concentrations. For precision, the goal is consistent detection above the cutoff and consistent non-detection below the cutoff. For method comparison, the aim is high agreement with the confirmatory method, especially for samples near the cutoff.

Table of Performance (Based on "Precision/Reproducibility" and "Method Comparison Study" sections):

• Operator A: 1 sample (494.481 ng/mL, expected positive) was reported positive.
• Operator B: 1 sample (491.559 ng/mL, expected positive) was reported positive, 1 sample (619.861 ng/mL, expected negative) was reported negative.
• Operator C: 1 sample (491.559 ng/mL, expected positive) was reported positive, 1 sample (619.861 ng/mL, expected negative) was reported negative. (The document states "Accurate result" as + or - based on whether it tested above or below the cutoff, implying the device's output. The discordance is when the device's output ("accurate result") doesn't match the LC-MS/MS interpretation.) |
  | BAR | 300 | At Cutoff (300 ng/mL): 21-23 negative / 27-29 positive results out of 50 tests across 3 lots.
  At +25% Cutoff (375 ng/mL): 0-1 negative / 49-50 positive results.
  At -25% Cutoff (225 ng/mL): 50 negative / 0 positive results. | Overall: Good agreement.
  Examples:
• Operator A: 1 sample (304.564 ng/mL, expected negative) was reported negative.
• Operator B: 1 sample (294.112 ng/mL, expected positive) was reported positive.
• Operator C: 1 sample (271.093 ng/mL, expected positive) was reported positive, 1 sample (304.564 ng/mL, expected negative) was reported negative. |
  | BUP | 10 | At Cutoff (10 ng/mL): 24-25 negative / 25-26 positive results out of 50 tests across 3 lots.
  At +25% Cutoff (12.5 ng/mL): 0-1 negative / 49-50 positive results.
  At -25% Cutoff (7.5 ng/mL): 49-50 negative / 0-1 positive results. | Overall: Good agreement.
  Examples:
• Operator A: 1 sample (11.971 ng/mL, expected negative) was reported negative, 1 sample (9.635 ng/mL, expected positive) was reported positive.
• Operator B: 1 sample (10.385 ng/mL, expected negative) was reported negative.
• Operator C: 1 sample (9.149 ng/mL, expected positive) was reported positive. |
  | ... | ... | (Similar patterns observed for all other drugs listed: BZO, COC, MDMA, MET, MOP/OPI, MTD, OXY, PCP, TCA, THC, FYL) | (Similar patterns observed for all other drugs listed, with specific discordant samples detailed in the raw tables. The "Accurate Result" column appears to denote the manual interpretation of the device's result, implying it was designed to align with LC/MS/MS around the cutoff. The discordance is where the device's result does not align with the LC-MS/MS value relative to the cutoff.) |

Key Acceptance Criteria (Implicit from Study Design):

• Precision/Reproducibility: The device should consistently return positive results for samples significantly above the cutoff concentration and consistently negative results for samples significantly below the cutoff. Near the cutoff, a mix of positive and negative results is expected due to inherent assay variability.
• Analytical Specificity/Interference: The device should accurately detect the target drug without significant cross-reactivity from other structurally similar compounds or interference from common endogenous/exogenous substances.
• Method Comparison: A high level of agreement between the device's qualitative results and the quantitative LC-MS/MS confirmatory method, especially for samples near the cutoff.
• Lay Person Usability: Intended lay users should be able to understand and follow instructions and obtain correct results.

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

• Analytical Performance (Precision/Reproducibility):

  • Sample Size: For each drug, 8 concentrations (+100%, +75%, +50%, +25%, cutoff, -25%, -50%, -75%, -100% cutoff). Each concentration was tested two runs per day for 25 days using three lots of test panels.
    • This means (8 concentrations * 2 runs/day * 25 days * 3 lots) = 1200 tests per drug.
  • Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. The concentrations were confirmed by LC-MS/MS. This suggests controlled laboratory conditions. The country of origin is not specified but the submitter is Hangzhou AllTest Biotech Co.,Ltd (China) and contact person is in Maryland (USA), so the testing location could be either. Retrospective, as samples were prepared.

• Method Comparison Study:

  • Sample Size: For each drug, 80 unaltered urine clinical samples (40 negative and 40 positive).
  • Data Provenance: "Unaltered urine clinical samples." The source of these clinical samples (e.g., country of origin, prospective or retrospective collection) is not explicitly stated, but "clinical samples" generally implies collection from human subjects. As they were "unaltered," they were likely retrospective, though collection parameters are not detailed.

• Lay Person Study:

  • Sample Size: 140 lay persons.
  • Sample Types: Urine samples created by spiking drug(s) into drug-free pooled urine specimens at various concentrations (-100%, +/-75%, +/-50%, +/-25% of the cutoff). Each participant tested 1 blind-labeled sample. This means 20 samples were used for each of the 7 concentrations (+/-100%, +/-75%, +/-50%, +/-25% of the cutoff for each drug).
  • Data Provenance: Controlled laboratory setting using spiked, blind-labeled samples. The study was performed at "three intended user sites," implying locations where lay persons would typically use such a device. Country not specified. Retrospective setup using prepared samples.

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

• This device is not an AI-based medical device. Ground truth for the analytical and method comparison studies was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry), which is considered the gold standard for quantitative drug concentration measurement in urine. LC-MS/MS does not rely on expert readers for interpretation in the same way imaging or pathology might.
• For the lay person study, the ground truth was the known concentration of the spiked samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Analytical Study (Precision) & Method Comparison: The ground truth was established by LC-MS/MS. The device's result was then compared to this LC-MS/MS reference. There was no "adjudication" in the sense of multiple human readers resolving discrepancies; the LC-MS/MS result served as the definitive reference.
• Lay Person Study: The ground truth was the known concentration of the spiked samples. The lay person's result was compared directly to this known concentration.

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 device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool. Its performance is evaluated as a standalone test, and for lay-user interpretation against a ground truth.

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

• Yes, the "Precision/Reproducibility" and "Method Comparison Study" sections represent the standalone performance of the device (which is an immunochromatographic assay, not an algorithm) without human interpretation variability, as results were compared directly to LC-MS/MS.
• The "Lay Person Study" then evaluated human-in-the-loop performance (i.e., how lay users interpret the device's results).

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

• The primary ground truth for the analytical and method comparison studies was LC-MS/MS quantitative analysis, which is a highly accurate chemical method for measuring drug concentrations.
• For the lay person study, the ground truth was the known, spiked concentrations of the drug in the urine samples.

8. The sample size for the training set

• This document describes a 510(k) premarket notification for an in-vitro diagnostic device, not an AI/ML device. Therefore, there is no "training set" in the context of machine learning model development.

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

• As stated above, this is not an AI/ML device, so there is no "training set." The performance studies rely on LC-MS/MS as the reference method and known spiked concentrations for establishing ground truth for evaluation.

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ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.

Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format. Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.

The provided document describes the Shinetell™ Digital Pregnancy Test, a device for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy, for over-the-counter use. The document focuses on demonstrating the device's performance characteristics and its substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table, but the performance characteristics evaluated serve as the de facto criteria for demonstrating substantial equivalence. The key performance metrics and their reported results are:

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

• Analytical Performance (Precision/Sensitivity):

  • Sample Size: For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots. With 3 operators, this resulted in 50 tests per operator per lot per concentration (10 replicates/day * 5 days), totaling 150 tests per concentration per lot.
  • Overall Sensitivity Sample Size: For the sensitivity conclusions, the most critical concentrations (0, 12.5, 25, 50, 100, 200 mIU/mL) each had 300 tests (3 lots * 50 replicates * 2 methods, or summarized directly as 300 total results).
  • Data Provenance: The document does not specify the country of origin for these spiked urine samples. It implies a laboratory setting for the spiking and testing, rather than patient samples. The study is retrospective in the sense that controlled samples were created for testing.

• Specificity and Cross-Reactivity:

  • Non-pregnant females: 300 samples (100 from each age group: pre-menopausal, peri-menopausal, post-menopausal).
  • Cross-reactive substances/hCG ß-core fragment: Number of samples not explicitly stated per substance/concentration, but it involved "negative and positive female urine samples" spiked with the substances.
  • Data Provenance: Not specified, but implied to be collected samples.

• Interfering Substances:

  • Number of samples not explicitly stated per substance/concentration, but involved "urine samples containing 0, 5 and 25 mIU/mL hCG" spiked with the substances.
  • Data Provenance: Not specified, implied to be collected urine samples spiked in a lab setting.

• Method Comparison Study:

  • Sample Size: 200 women presenting to test for pregnancy, suspected to be pregnant (early stage, less than 5 weeks).
  • Data Provenance: Retrospective, collected from patients at three Point-of-Care (POC) sites. Country of origin not specified.

• Lay Person Study:

  • First Study (self-testing): 200 women (individual pregnancy status self-tested).
  • Second Study (blinded spiked samples): 100 laypersons for 5 mIU/mL hCG aliquots and 100 laypersons for 25 mIU/mL hCG aliquots.
  • Data Provenance: "Individuals with varying educational and occupational backgrounds from three sites." Country of origin not specified. The first study used patient samples (their own urine); the second used controlled, spiked samples. Both are prospective in terms of the layperson testing event.

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

• Analytical Performance (Precision/Sensitivity): Ground truth was established by the known concentration of hCG spiked into the negative urine samples, traceable to the 5th WHO International Standard. No human experts were used to interpret these results beyond confirming the digital readout.
• Specificity, Cross-reactivity, Interfering Substances: Ground truth was established by the known negative status of the samples or the known spiked concentrations.
• Method Comparison Study: The predicate device served as the "ground truth" for comparison. The study states "3 different professionals using the candidate device and 1 professional using the predicate device at each site." Their qualifications are not specified beyond "professionals."
• Lay Person Study:
  • First Study (self-testing): The "professional results" served as ground truth for comparison with layperson results. The qualifications of these "professionals" are not specified.
  • Second Study (blinded spiked samples): The known spiked concentration (5 mIU/mL hCG meant to be negative, 25 mIU/mL hCG meant to be positive) acted as the ground truth. A "study administrator" was present to observe; their role was not to establish ground truth but to monitor the study.

4. Adjudication Method for the Test Set

The document does not describe a formal "adjudication method" involving multiple readers/experts to resolve discrepancies for the test sets.

• For analytical performance, ground truth was by spiking, so no adjudication needed.
• For method comparison and lay person studies, comparison was made against the predicate device results or professional results (in the case of actual patient samples). In the second layperson study, ground truth was by known concentration. Discrepancies (if any arose) or how they were handled (e.g., re-testing, exclusion) are not explicitly detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a digital pregnancy test with a clear "Pregnant" or "Not Pregnant" readout, not an imaging device requiring human interpretation for complex diagnostic decisions. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance is not applicable to this device. The "human readers" (laypersons) are using the device to get a direct digital output, not making an interpretation with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the "Analytical Performance" section (Precision/Sensitivity, Hook Effect, Specificity, Interfering Substances) represents the standalone performance of the device, as it evaluates the device's ability to detect hCG at various concentrations and in the presence of challenging substances, independent of human interpretation variability. The digital output is the algorithm's direct result.

7. The Type of Ground Truth Used

The types of ground truth used varied depending on the performance characteristic being evaluated:

• Known Spiked Concentrations: For sensitivity, hook effect, cross-reactivity (with defined interferers), and the second layperson study. This is a highly controlled, artificial ground truth.
• Clinical (Patient) Samples with Known Status (or compared to predicate/professional): For method comparison study and the first layperson study. Here, the "ground truth" was either the result from the legally marketed predicate device or the result from a "professional" using the candidate device, implying a clinical assessment of the patient's pregnancy status (e.g., confirmatory lab tests, clinical history).

8. The Sample Size for the Training Set

The document does not provide information on the training set size because this is not an AI/ML device that requires a separate "training set" in the conventional sense. This is an immunoassay device with a digital readout mechanism based on light intensity detection. Its "design" is based on biochemical and optical principles, not on learned parameters from a large dataset. Therefore, there's no "training set" as would be seen for, say, an image-recognition AI algorithm.

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

As noted in point 8, there is no "training set" for this type of device in the context of an AI/ML algorithm. The device's operational parameters (e.g., thresholds for light intensity to display "Pregnant" or "Not Pregnant") are likely established during the device's development and internal validation processes using controlled, known concentrations of hCG, similar to the analytical performance testing described.

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AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The document describes the "AllTest Multi-Drug Urine Test Cup" and "AllTest Multi-Drug Rapid Urine Test Cup" and their performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically demonstrated through precision studies, where the device consistently identifies samples at, above, and below predefined cutoff concentrations. The performance data presented in the "Precision/Reproducibility" section serves as the primary evidence. For qualitative tests, the acceptance criteria relate to the agreement with expected results at various concentrations relative to the cutoff.

Acceptance Criteria (Implied from the study design):

• At or above +25% cutoff: Expected to report as "Positive" (drug detected).
• At or below -25% cutoff: Expected to report as "Negative" (no drug detected).
• Around cutoff (+/- 25% of cutoff): A mix of positive and negative results is expected, reflecting the inherent variability near the cutoff threshold. This range is often considered the "equivocal" zone.
• Specificity (Cross-Reactivity): Low cross-reactivity with non-target compounds.
• Interference: No significant interference from common urine interferents or variations in pH and specific gravity.
• Lay-person usability: High agreement rate for lay users.

Reported Device Performance (from "Precision/Reproducibility" and "Lay Person Study"):

2. Sample Size and Data Provenance for Test Set

• Precision/Reproducibility Study:

  • Sample Size: For each drug concentration level (e.g., +100% cutoff, -100% cutoff, and 7 intermediate levels), tests were performed two runs per day for 25 days using three lots of test cups. This means for each drug and each concentration, there were 2 runs/day * 25 days/lot * 3 lots = 150 test results recorded (number of negative and positive results).
  • Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. The origin of the "drug-free urine samples" is not explicitly stated (e.g., country of origin). The study is retrospective in the sense that samples were artificially prepared and spiked, but prospective in the sense of testing these prepared samples by the device.

• Method Comparison Study:

  • Sample Size: 80 unaltered urine clinical samples were used for each drug (40 negative and 40 positive). This means 80 clinical samples per drug were tested against LC-MS/MS.
  • Data Provenance: "unaltered urine clinical samples" - the country of origin is not specified. The study is retrospective as pre-collected samples were tested.

• Lay Person Study:

  • Sample Size: 140 lay persons. 20 samples were tested per concentration level for each drug. The samples were prepared by spiking drug(s) into drug-free pooled urine specimens at various concentrations.
  • Data Provenance: Not specified for the drug-free pooled urine or the participants' origin. This study is prospective for the participants interacting with the device, but the samples themselves were artificially prepared.

3. Number of Experts and Qualifications for Ground Truth - Test Set

• Precision/Reproducibility Study: The ground truth was established by the manufacturer. "Each drug concentration was confirmed by LC-MS/MS." LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly accurate analytical chemistry technique. The individuals performing or analyzing LC-MS/MS results are typically trained laboratory technicians or chemists, but their specific "expert" qualifications (e.g., years of experience, certification) are not detailed.
• Method Comparison Study: The ground truth was established using LC-MS/MS results. Similar to the precision study, this relies on a precise analytical method, implying expert knowledge in operating and interpreting LC-MS/MS, but specific qualifications of individuals are not provided.
• Lay Person Study: The ground truth for the spiked samples was confirmed by LC-MS/MS.

4. Adjudication Method for Test Set

• Precision/Reproducibility Study: Not applicable in the traditional sense, as the ground truth was analytically determined by LC-MS/MS concentrations. The results are presented as counts of positive/negative.
• Method Comparison Study: Not applicable. The device's results were directly compared to the LC-MS/MS results. Discordant results (where the device disagreed with LC-MS/MS) are listed individually, but no further adjudication process is described beyond the quantitative LC-MS/MS result being the "Accurate Result."
• Lay Person Study: Not applicable. Lay users interpreted the device, and their interpretations were compared to the LC-MS/MS confirmed concentrations of the spiked samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test cup, not an AI-powered diagnostic system requiring human interpretation comparison. The "Lay person study" involved human readers (lay persons) but it was to assess their ability to use and interpret the device alone, not in comparison to an assisted workflow.

6. Standalone Performance

Yes, a standalone performance study was done. The precision/reproducibility and method comparison studies directly assess the algorithm's (the device's) performance in detecting drugs in urine samples compared to established analytical methods (LC-MS/MS) without human-in-the-loop assistance influencing the result (though humans perform the test and read the result line on the cup). The "Lay person study" also shows standalone performance as interpreted by lay users.

7. Type of Ground Truth Used

• Analytical Ground Truth: For the "Precision/Reproducibility" and "Lay Person" studies, the ground truth was analytically determined concentrations confirmed by LC-MS/MS after spiking known amounts of drugs into drug-free urine.
• Confirmatory Method Ground Truth: For the "Method Comparison Study," the ground truth was established by LC-MS/MS results on unaltered urine clinical samples.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI model development. This device is a rapid immunochromatographic assay, which is a chemical and biological test, not typically an AI/machine learning device that requires a training set. The various studies (precision, method comparison, lay person) serve as validation of the device's performance.

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

As no training set is mentioned for an AI/ML algorithm, this question is not applicable. The device itself is based on antigen-antibody reactions, not a trained algorithm.

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AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the acceptance criteria and the studies conducted for the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel for the detection of various drugs in human urine. The submission primarily focuses on the three new analytes: Amphetamine 1000, Cocaine 300, and Methamphetamine 1000, while referencing a previous submission (K182738) for other analytes.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests typically revolve around the ability to correctly identify samples above and below the specified cut-off concentrations. The precision study results implicitly serve as the performance criteria, showing the percentage of correct identifications at various concentrations relative to the cut-off.

Acceptance Criterion: The device should consistently provide correct positive results for samples at or above the cut-off concentration and correct negative results for samples significantly below the cut-off concentration. For samples near the cut-off, a certain degree of variability is expected but needs to be within acceptable ranges (e.g., majority of results correctly identified).

Reported Device Performance (from Precision Studies - 3 lots, 25 replicates each, total 75 tests per concentration level):

Lay User Study Performance (Cup & Panel combined, n=20 per concentration level per drug):

(Note: The table only includes performance for the new analytes (AMP 1000, COC 300, MET 1000) for precision, and for all listed analytes in the lay user study, which implicitly includes the other cut-off values for AMP, COC, and MET, as well as the other drugs reported in K182738.)

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

Precision Studies (Laboratory Testing):

• Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 9 concentration levels were tested. For each concentration, 5 replicates were performed per day for 5 days, across 3 lots.
  • This equates to: 9 concentrations * 5 replicates/day * 5 days * 3 lots = 675 total tests per analyte for the precision study using spiked urine samples.
• Data Provenance: The document states, "These samples were prepared by spiking drug in negative urine samples." This indicates the data is from prospective, laboratory-controlled experiments using spiked urine samples. The country of origin for the samples themselves is not explicitly stated beyond being "negative urine samples," but the submitting company is Hangzhou Alltest Biotech Co.,Ltd. in China, suggesting the studies likely occurred there or with materials sourced globally.

Comparison Studies (Clinical Samples):

• Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 80 unaltered clinical urine samples were used (40 negative and 40 positive).
  • This totals 80 samples per analyte (Cup and Panel results are reported on the same sample set).
• Data Provenance: The document states, "unaltered clinical samples." This suggests these were retrospective clinical samples. The country of origin is not specified.

Lay User Study:

• Sample Size: 560 lay persons participated. Urine samples were prepared at 7 concentration levels (negative, +/-25%, +/-50%, +/-75%, +100% of cut-off) for each drug. Each participant was provided with 1 blind labeled sample and a device.
  • For each of the approximately 14 drugs/cut-off concentrations evaluated, there were 7 concentration levels. Each concentration level had 20 tests (Agreement (%) is based on 20 total for each row). So, at minimum, 14 drugs * 7 concentrations * 20 tests/concentration = 1960 total tests were performed by lay users, distributed across the 560 participants.
• Data Provenance: The samples were "prepared by spiking drugs into drug free-pooled urine specimens," indicating prospective, laboratory-controlled experiments using spiked urine samples. The study was performed at "three intended user sites" but the country/region is not specified.

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

Precision Studies and Lay User Studies:

• Ground Truth Establishment: The ground truth for these studies was established by spiking known concentrations of drugs into negative urine samples and confirming them by LC/MS. This is a chemical/analytical method, not expert opinion.
• Number of Experts & Qualifications: Not applicable, as the ground truth was determined analytically.

Comparison Studies (Clinical Samples):

• Ground Truth Establishment: The ground truth for the clinical samples was established using LC/MS (Liquid Chromatography-Mass Spectrometry), which is the recommended confirmatory method as stated in the Indications for Use.
• Number of Experts & Qualifications: Not applicable, as the ground truth was determined via a definitive analytical method, not human expert consensus. "Three laboratory assistants" ran the device tests, but they were not establishing the ground truth.

4. Adjudication Method for the Test Set

Precision Studies and Lay User Studies:

• Adjudication Method: Not applicable. The ground truth was based on known spiked concentrations confirmed by LC/MS. The device's result was compared directly to this analytical ground truth.

Comparison Studies (Clinical Samples):

• Adjudication Method: Not explicitly described in terms of human adjudication. However, the document states: "The samples were blind labeled and compared to LC/MS results." This implies a direct comparison against a definitive analytical method (LC/MS) for ground truth, rather than an adjudication process involving multiple human interpretations of the ground truth. The "Discordant Results" tables show discrepancies between the viewer (device interpreter) results and the LC/MS result, indicating the LC/MS was the adjudicating method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a typical MRMC comparative effectiveness study was not explicitly described in the context of human readers improving with AI vs. without AI assistance.
• The document describes a "Comparison Studies" section, but this compares the device's performance to LC/MS results. It also mentions three "Viewer" (likely laboratory assistants or technicians) evaluating the device results against LC/MS, but it's not a study about human readers improving with AI assistance. It's a study of the device's performance when interpreted by human users against a gold standard.
• The device itself is a rapid test cup/panel, not an AI software.

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

• Not applicable. The device is an immunochromatographic assay (a physical test strip/cup), not an algorithm or AI software. Its performance inherently involves human-in-the-loop for result interpretation (reading the lines). The "Precision" study and the "Comparison Studies" evaluate the device's standalone analytical performance, but its practical use and reported performance include human interpretation of its visual output. The "Lay User Study" specifically evaluates performance with human-in-the-loop (lay users interpreting the results).

7. The Type of Ground Truth Used

• Precision Studies & Lay User Studies: The ground truth was established by spiking known concentrations of drugs into drug-free urine samples, with these concentrations confirmed by LC/MS. This is an analytically derived ground truth.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a definitive analytical gold standard for drug detection.

8. The Sample Size for the Training Set

The document does not describe the development of an algorithm or AI model that would require a "training set." This device is a rapid diagnostic test based on immunochromatography. Therefore, the concept of a training set as used in machine learning is not applicable here.

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

As noted above, there is no mention of a training set for an algorithm or AI model. The device operates on chemical and immunological principles, not machine learning.

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AllTest Fentanyl Urine Test Cassette is is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. 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. For in vitro diagnostic use only.

AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and study details for the AllTest Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on the lay user study demonstrating accurate detection of fentanyl at various concentrations relative to the 1 ng/mL cutoff. The reported device performance is indicated by the percentage of correct results from the lay user study, demonstrating high accuracy across different spiked concentrations.

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AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

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.

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and the study details for the AllTest Fentanyl Rapid Test (Urine), based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally inferred from the positive and negative agreement with the LC/MS reference method, especially around the cutoff concentration. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the performance in the method comparison study demonstrates the device's ability to classify samples correctly.

• Lot 1: 58-/2+
• Lot 2: 59-/1+
• Lot 3: 60-/0+
  For Cutoff:
• Lot 1: 35+/25-
• Lot 2: 28+/32-
• Lot 3: 26+/34-
  For +25% Cutoff:
• All lots 60+/0- |
  | Interference:
  No interference from common endogenous or exogenous substances at specified concentrations. | Over 80 tested compounds showed no interference at 100 µg/mL or specified concentrations (except Trazodone with 0.1% cross-reactivity). |
  | Specificity (Cross-reactivity):
  Limited cross-reactivity with structurally similar compounds. Other opioids show no cross-reactivity. | Detailed cross-reactivity provided for 17 fentanyl analogs; 21 other opioid compounds showed no cross-reactivity. |
  | Effect of Urine Specific Gravity and pH:
  Accurate results across a range of urine specific gravities and pH levels. | Consistent results (positive for +50% Cut-Off and above, negative for -50% Cut-Off and below) over specific gravity 1.000-1.035 and pH 4-9. |

Study Details

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Operators ran 80 unaltered clinical samples at each of the three testing sites. This means a total of 240 tests were performed on the clinical samples (80 samples * 3 sites). Each sample was characterized by LC/MS results (40 negative and 40 positive for fentanyl).
• Data Provenance: The document states "unaltered clinical samples." The country of origin is not specified, but the device manufacturer is based in Hangzhou, Zhejiang, China. The study appears to be prospective in the sense that the device was used to test these clinical samples, and the results were then compared to LC/MS.

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

• Ground Truth Establishment: The ground truth for the test set was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing, rather than human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as the ground truth was industrial standard LC/MS. Discordant results were identified by direct comparison to the LC/MS reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly done. The study compares the device's performance against a gold standard (LC/MS), not against human readers with and without AI assistance. The device itself is an immunoassay, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

• Standalone Performance: Yes, the described method comparison study is a standalone (algorithm only without human-in-the-loop performance) study, as it evaluates the device's ability to detect fentanyl in urine samples independently and compares its results to LC/MS. Human operators ran the tests, but their interpretation was based on the test line development, which is an intrinsic function of the device's chemistry.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was established by LC/MS/MS results, specifically for fentanyl concentration, with a cutoff of 1.0 ng/mL. LC/MS is a highly accurate and sensitive analytical chemistry technique considered the gold standard for confirming the presence and quantity of drugs in biological samples.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay and relies on chemical reactions, not on an algorithm that requires a training set. The various analytical performance studies (precision, interference, specificity) are internal validation studies that support the device's design and analytical capability, but these are not typically referred to as "training sets" in the same way as in AI/ML development.

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

• Ground Truth for Training Set: Not applicable, as there is no explicitly defined "training set" for this immunoassay device in the context of AI/ML. All samples used in the analytical performance studies (precision, interference, specificity) involved prepared samples with known concentrations of fentanyl or interfering substances, often confirmed by LC/MS, or drug-free urine.

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