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The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

Here's an analysis of the acceptance criteria and study details for the Assure Tech hCG Pregnancy Serum/Urine Combo Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its "precision/reproducibility/cut-off value" and "method comparison" studies. The goal is to perform accurately around the established cut-off values and show strong agreement with a predicate device.

Study Details

1. Sample Size and Data Provenance:

   • Test Set (Precision/Reproducibility): For each format (Serum Strip, Serum Cassette, Urine Strip, Urine Cassette), 150 replicates were used for each hCG concentration level (10 replicates per site x 3 sites x 5 days for each of 3 lots = 450 total data points per concentration level for each format). Total tests: 10 concentrations per serum format, 10 for urine strip, 10 for urine cassette. This would be a massive number, but the table combines the three lots and three operators. So for each concentration, 150 total tests (3 sites x 50 tests per site). This means for Serum Strip, 150 tests at 0 mIU/mL, 150 tests at 4 mIU/mL, and so on.
     • Provenance: This data was generated in vitro by spiking negative serum/urine specimens with hCG. The origin of the negative serum/urine is not specified (e.g., country) but is likely lab-obtained.
   • Test Set (Method Comparison): 120 urine samples and 120 serum samples were collected.
     • Provenance: The samples were collected prospectively from 120 women (ages 18-49, about half pregnant and in early stages < 5 weeks) from three testing sites. The country of origin is not explicitly stated, but the submitter is in Hangzhou, China, and the regulatory consultant is in Maryland, USA. It's common for such studies to be multi-site, and given the FDA submission, the data would ideally meet international standards.
   • Training Set: The document does not describe a training set as this is an immunoassay, not a machine learning algorithm.

2. Number of Experts and Qualifications (Test Set Ground Truth):

   • For the precision study, results were interpreted by "three different operators." Their qualifications are not specified beyond being "operators."
   • For the method comparison study, samples were tested by "six different health professionals." Their specific qualifications (e.g., type of professional, experience level) are not detailed.
   • The primary "ground truth" for these studies is the known concentration of spiked hCG for precision, and the result from the predicate device for method comparison.

3. Adjudication Method (Test Set):

   • The document does not explicitly describe an adjudication method for conflicting results if they occurred during the precision or method comparison studies. For the precision study, it shows the aggregate positive/negative counts. For the method comparison, it reports 100% agreement, suggesting no need for adjudication for the final results presented.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study in the typical sense (where human readers interpret cases with and without AI assistance to measure improvement) was not done. This device is a diagnostic test kit (immunoassay), not an AI algorithm assisting human interpretation of complex data (like radiology images). The "comparison studies" section refers to comparing the new device's results to a predicate device, and the "operators" or "health professionals" are performing the test and reading the visual result, not interpreting complex cases.

5. Standalone Performance:

   • Yes, the performance presented for the "Analytical Performance" (precision, stability, specificity, interference) and "Comparison Studies" represents the standalone performance of the Assure Tech hCG Pregnancy Serum/Urine Combo Test. It is an algorithm-only (test kit only) without a human-in-the-loop interaction beyond performing the test and visually reading the results.

6. Type of Ground Truth Used:

   • Precision/Reproducibility: The ground truth was based on known spiked concentrations of hCG (traceable to the 4th WHO international Standard).
   • Method Comparison: The ground truth was established by comparison to a legally marketed predicate device (QuickVue+ One-Step hCG Combo test, K973858), implying the predicate device's results serve as the reference. Additionally, the samples were collected from "pregnant" and "non-pregnant" women, suggesting clinical status (outcomes data regarding pregnancy) was also a factor in sample selection.

7. Sample Size for the Training Set:

   • Not applicable. This is an immunoassay kit, not a machine learning model, so there is no "training set."

8. How Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set.

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The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.

The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.

The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech Bunrenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Buprenorphine and/or Methadone (target analytes) in human urine. The Quick Cup format does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The provided document is a 510(k) Premarket Notification for in vitro diagnostic devices designed to detect Buprenorphine and Methadone in human urine. It details the performance characteristics of these devices.

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

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria are generally implied by the performance goals set for the device, particularly regarding concordance with GC/MS results and successful performance across various drug concentrations. The precision studies and comparison studies demonstrate the device's performance against these implicit criteria.

Note: The document doesn't explicitly state numeric "acceptance criteria" for accuracy (e.g., "must achieve 90% positive agreement with GC/MS at +25% cutoff"). Instead, the data is presented, and the conclusion states that the performance characteristics are "acceptable." We can infer the acceptance criteria from the observed performance and the nature of qualitative drug tests.

Here is a summary of the reported device performance from the "Precision" and "Comparison Studies" sections:

Precision Studies (Table Summarization):

• Test Setup: Samples at -100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% of the cut-off concentration. Confirmed by GC/MS. Blindly labeled. 2 runs per day for 25 days per device (total of 50 tests per concentration per lot). Three lots of each device were tested.
• Performance:
  • Buprenorphine: For all device types (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) across three lots:
    • All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ (50 negative, 0 positive) results.
    • All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- (50 positive, 0 negative) results.
    • Results at the "cut off" (0% cut-off, which should be 10 ng/mL) showed some variability, as expected for qualitative tests around the threshold. For example, for Buprenorphine Strip, Lot 1 showed 4-/46+ (4 negative, 46 positive) at cut-off, while Lot 2 showed 1-/49+. This indicates the ability to correctly identify samples near the cutoff, with some expected variation around the 50/50 mark.
  • Methadone: Similar trends were observed for Methadone across all device types and lots.
    • All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ results.
    • All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- results.
    • Results at the "cut off" (0% cut-off, 300 ng/mL) showed variability, e.g., Methadone Strip, Lot 1 showed 2-/48+.

Comparison Studies with GC/MS (Table Summarization using a general view as specific numerical acceptance criteria like sensitivity/specificity are not given, but concordance is key):

• Setup: In-house study with 80 unaltered clinical samples (40 negative, 40 positive) per drug per device type. Operators ran blind-labeled samples. GC/MS was the reference method. Each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) was evaluated for both Buprenorphine and Methadone.
• General Performance (Across all device types for Buprenorphine and Methadone):
  • Negative Samples: Consistently showed 10 Negative (from true negative GC/MS) and 20 Low Negative (GC/MS < -50% cut-off) results.
  • Near Cutoff Negative: Showed 8 or 9 Negative results and 1 or 2 Positive results (e.g., Buprenorphine Strip, Viewer A, had 8 Negative, 2 Positive). This indicates some "false positives" or reads as positive for samples slightly below the cutoff.
  • Near Cutoff Positive: Showed mostly Positive results (13-15 positive, 0-2 negative). This indicates some "false negatives" or reads as negative for samples slightly above the cutoff.
  • High Positive: Consistently showed 25 Positive results.
• Discordant Results: The tables explicitly list the GC/MS result and the device's viewer result for discordant samples (those where the device's reading did not match the GC/MS result, usually near the cutoff). For instance, for Buprenorphine Strip, sample 11178 (GC/MS 9.8 ng/mL, cutoff 10 ng/mL) was read as Positive by Viewer A, while sample 31718 (GC/MS 10.9 ng/mL) was read as Negative by Viewer A. This highlights the inherent variability near the cutoff for qualitative assays.

Lay-User Study (Table Summarization):

• Setup: 1113 lay persons at three user sites. Urine samples prepared at -100%, -75%, -50%, -25%, +25%, +50%, +75% of the cut-off. Confirmed by GC/MS. Blind-labeled. Each participant received 1 sample and 1 device.
• Performance (Overall, aggregated results across all device types show good agreement):
  • Buprenorphine Strip (Example):
    • -100%, -75%, -50% cut-off: 100% correct negative results.
    • -25% cut-off: 95% correct negative results (1 positive out of 21).
    • +25%, +50%, +75% cut-off: 95-100% correct positive results. (e.g., +25% cutoff, 20+/1- for Buprenorphine Strip, 95% correct).
  • Methadone Strip (Example): Similar strong performance to Buprenorphine.
    • -100%, -75%, -50% cut-off: 100% correct negative results.
    • -25% cut-off: 95% correct negative results (1 positive out of 21).
    • +25%, +50%, +75% cut-off: 95-100% correct positive results. (e.g., +25% cutoff, 20+/1- for Methadone Strip, 95% correct).
  • Panel Dip/Turn-Key/Quick Cup: Similar high percentages of correct results, with slight variations around the -25% and +25% cut-off points, as observed in the Strip tests.

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

• Test Set (Precision Studies): For each drug (Buprenorphine, Methadone), for each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup), and for each of the 3 lots, samples were tested across 8 concentration levels. Each concentration was tested 50 times (2 runs/day for 25 days). So, for one drug and one device type, it's 3 lots * 8 concentrations * 50 tests = 1200 tests. Given there are 4 device types, this would be 4800 tests for Buprenorphine and similarly for Methadone.
• Test Set (Comparison Studies): For each device type (e.g., Buprenorphine Strip), 80 unaltered clinical samples (40 negative and 40 positive) were used. This was done for each drug (Buprenorphine, Methadone) and for each of the 4 device types. So total: 4 (device types) * 2 (drugs) * 80 (samples) = 640 clinical samples.
• Test Set (Lay-user study): 1113 lay persons participated. Urine samples were prepared at 7 concentration levels. Each participant was provided with one blind-labeled sample and one device. Assuming each person tested one sample, the sample size for this test is 1113 unique sample-device readings. However, the data presented in the tables for the lay-user study shows 21 samples per concentration level, for each drug and device type. This means multiple subjects tested samples from the same concentration group.
• Data Provenance:
  • Precision and Interference/Specificity/Cut-off Studies: Samples were "prepared by spiking drug in negative samples" which were confirmed by GC/MS. This suggests controlled laboratory samples.
  • Comparison Studies: "unaltered clinical samples." The document does not specify the country of origin of these clinical samples, nor does it explicitly state if they were retrospective or prospective, but the phrasing "unaltered clinical samples" suggests real-world specimens.
  • Lay-user study: "Urine samples were prepared... by spiking drug(s) into drug free-pooled urine specimens." Again, controlled laboratory samples, not clinical samples. Three "intended user sites" were used, but their location/country is not specified.

3. Number of Experts and Qualifications to Establish Ground Truth

• Precision/Prepared Samples: The ground truth for these samples was established chemically by GC/MS (Gas Chromatography/Mass Spectrometry), which is stated as the "preferred confirmatory method" and the method used to "confirm" sample concentrations. No human experts are explicitly mentioned for establishing ground truth for these spiked samples, as GC/MS is a quantitative analytical method providing objective chemical concentrations.
• Comparison Studies (Clinical Samples): The ground truth for the 80 unaltered clinical samples was also established by GC/MS.
• Lay-user Study: Ground truth for these prepared samples was established by GC/MS.
• Qualifications of Experts: The document states that the GC/MS confirmation was done. This method itself provides the "ground truth." While laboratory personnel would operate the GC/MS, their specific qualifications for establishing ground truth (like radiologists for imaging studies) are not pertinent in this chemical assay context.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is described for the test set.
• For the precision studies, results were observed ("50-/0+", "4-/46+", etc.) across multiple runs and lots.
• For the comparison studies, "three laboratory assistants" operated the device, and their results (labeled Viewer A, B, C) were directly compared to the GC/MS truth. There is no mention of these "viewers" adjudicating their readings or a consensus process. Discordant results are simply listed.
• For the lay-user study, lay persons read the device results. The comparison is between the lay person's reading and the GC/MS-confirmed concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not performed in the traditional sense as described for AI vs. human assistance. This is a qualitative drug test, not an AI imaging device where human readers interpret cases and AI provides assistance.
• The "Comparison Studies" involved "three laboratory assistants" (analogous to multiple readers), who read the results of the device on clinical samples. Their readings were compared against GC/MS. This is a form of multi-reader study, but it's evaluating the device's performance when read by different individuals, rather than AI assisting human interpretation.
• Therefore, an "effect size of how much human readers improve with AI vs. without AI assistance" is not applicable or provided.

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

• This device is a rapid immunochromatographic assay (a "dipstick" type test), not a software algorithm. Therefore, the concept of a "standalone" algorithmic performance without human interpretation does not apply. The device produces a visual result (lines appearing or not appearing), which requires human observation to interpret.

7. The Type of Ground Truth Used

• The primary ground truth used throughout the studies is Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate and widely accepted analytical method for confirming the presence and concentration of substances, making it a robust 'gold standard' for drug testing.

8. The Sample Size for the Training Set

• This document describes performance characteristics for a rapid immunochromatographic assay, which is a chemical and biological test, not a machine learning model.
• Therefore, there is no "training set" in the context of an AI/ML algorithm. The device's performance is inherent to its physical and chemical design and manufacturing process.

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

• As there is no "training set" for an AI/ML model, this question is not applicable.

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