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FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. 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. It is intended for over-the-counter and for prescription use.

FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. 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. It is intended for over-the-counter and for prescription use.

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow system for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

This document describes the performance characteristics of the FaStep Marijuana Tests and FaStep Methamphetamine Tests. These are immunochromatographic assays for the qualitative determination of 11-nor-Δ9-THC-9-COOH (Marijuana metabolite) and Methamphetamine in human urine, manufactured by POLYMED THERAPEUTICS, INC. The document presents data to demonstrate that the devices meet acceptance criteria for precision, cut-off verification, interference, specificity, and comparison with a reference method (GC/MS).

Here's a breakdown of the requested information, adapted from the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance of the device in various studies. The core acceptance is accurate qualitative determination (positive/negative) at specific cut-off concentrations, with high correct result percentages and low rates of false positives/negatives, especially near the cut-off.

Overall Performance Summary (Inferred Acceptance Criteria vs. Reported Performance):

MET: 3,4-Methylenedioxymethamphetamine (MDMA) showed high cross-reactivity (200%), which is physiologically relevant for methamphetamine testing. Other compounds showed lower cross-reactivity (e.g., L-Methamphetamine at 10%, Ephedrine at 25%) or were not detected (D-Amphetamine). "No differences observed for different formats." |
| Comparison Studies (Clinical Samples) | High agreement with GC/MS results, particularly for samples near the cut-off, demonstrating clinical validity. Minimal discordant results. | For both THC and MET tests across all formats, 80 clinical samples (40 negative, 40 positive) were tested. The tables show a high concordance with GC/MS results. Discordant results primarily occurred for samples very close to the cut-off concentration, either false positives slightly below cut-off or false negatives slightly above cut-off (e.g., 1-2 discordant results per viewer for THC and MET strip format, typically within 25% of the cut-off). Overall high agreement was demonstrated. |
| Lay-User Study | High percentage of correct interpretations by lay users, and clear, easy-to-understand instructions. | Across all formats (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) for both THC and MET, lay users achieved 100% correct results for samples at -100%, -75%, -50% cut-off (negative) and +25%, +50%, +75% cut-off (positive). For samples at -25% cut-off, correct results ranged from 90.2% to 95.2% (some false positives). For samples at +25% cut-off, THC tests showed 100% correct results, while MET tests showed 95.2% to 100% depending on the format. All lay users indicated that the device instructions were easily followed (Flesch-Kincaid Grade Level 7). |

2. Sample Size and Data Provenance

• Precision Studies:

  • Sample Size: For each drug (THC, MET), each concentration level (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), across 3 different lots of the device, 50 tests were performed (2 runs per day for 25 days). This means for each drug and each format, 9 concentrations x 3 lots x 50 tests = 1350 data points per format were generated for precision, although only summarized frequency counts are provided.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-controlled samples prepared by spiking drugs into negative samples. The concentration was confirmed by GC/MS. This suggests a retrospective controlled laboratory study, likely conducted in the US (given the FDA submission).

• Cut-off Verification:

  • Sample Size: 150 samples equally distributed at concentrations of -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off. These were tested using three different lots of each device.
  • Data Provenance: Laboratory-controlled spiked samples.

• Interference & Specificity:

  • Sample Size: Concentrations of various compounds were tested in drug-free urine and in urine containing target drugs at 25% below and 25% above the cut-off. Tested using three batches (lots) of each device for all formats.
  • Data Provenance: Laboratory-controlled spiked samples.

• Comparison Studies (Clinical Samples):

  • Sample Size: 80 unaltered clinical samples per drug (40 negative and 40 positive, categorized based on GC/MS). These samples were used for each of the four device formats (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup).
  • Data Provenance: "In-house with three laboratory assistants." Samples were "unaltered clinical samples." The country of origin is not specified but is implicitly the US for an FDA submission. This was a retrospective study using existing clinical samples.

• Lay-User Study:

  • Sample Size: 147 lay persons. Urine samples were prepared at 7 concentration levels (negative, +/- 75%, +/- 50%, +/- 25% of the cut-off). Each participant was provided with 1 blind-labeled sample (implying each individual participant tested one sample concentration per drug type and format, making the overall sample count for analysis 21 samples per concentration level per drug type - 7 concentrations x 21 participants = 147 tests. Since both THC and MET were tested per participant per format, this would be 147 x 2 = 294 tests per format (or total if formats were varied).
  • Data Provenance: "Performed at three intended user sites." Controlled spiked samples, blind-labeled. This was a prospective study with lay users.

3. Number of Experts and Qualifications for Ground Truth

• Expert Establishment of Ground Truth: The ground truth for all analytical and clinical comparison studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted "gold standard" method for confirming drug concentrations in urine.
• Qualifications of Experts: The document does not specify the number or detailed qualifications of the individuals who performed the GC/MS analysis (e.g., "radiologist with 10 years of experience"). However, GC/MS is a laboratory analytical method, and it is assumed that the personnel operating such sophisticated equipment are qualified laboratory technicians/scientists with appropriate training and experience in analytical chemistry. For the comparison studies, three laboratory assistants performed the device readings. Their specific qualifications beyond "laboratory assistants" are not detailed.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is explicitly described for the individual readings of the rapid tests in the comparison studies.
• For the comparison studies, three laboratory assistants ("Viewers A, B, C") independently read the results of the 80 clinical samples for each device format. Their individual readings were then compared against the GC/MS ground truth. The discordant results are individually listed for each viewer against the GC/MS result. This implies independent assessment rather than a consensus or adjudication process among the viewers themselves for the final study result.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance.
  • This device is a rapid diagnostic test (lateral flow immunoassay) for drug screening, not an "AI-assisted" diagnostic imaging device (e.g., for radiology). Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable here.
  • The "human readers" in the comparison studies were laboratory assistants reading the strip/panel for a visible line, and lay users following instructions. There is no AI component involved in the interpretation of these tests according to the documentation provided.

6. Standalone (Algorithm Only) Performance

• Not applicable. As stated above, this is a chemical immunoassay, not an algorithm-only device. The test itself performs the "detection" by the presence or absence of a colored line, which is then interpreted by a human user. There is no software algorithm that provides a standalone diagnostic output without human involvement.

7. Type of Ground Truth Used

• The primary and definitive ground truth for all analytical and comparison studies was GC/MS (Gas Chromatography/Mass Spectrometry) results. GC/MS is a highly precise and accurate analytical method used to identify and quantify substances, making it a robust form of outcomes data or a highly regarded reference standard for determining the true concentration of drug metabolites in urine.

8. Sample Size for the Training Set

• Not applicable. This device is a biochemical immunoassay, not an AI/machine learning model that requires a "training set" of data. The manufacturing process and reagent formulations are established through traditional laboratory development and quality control, not through data-driven model training.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI/machine learning model, there is no ground truth to be established for such a set. The "ground truth" (i.e., known concentrations of analytes) used in the analytical performance studies (precision, cut-off, interference, specificity) was established by carefully prepared spiked samples with concentrations confirmed by GC/MS.

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The Fastep S10 hCG Serum/Urine Combo Test 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 only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

Fastep S10 hCG Serum/Urine Combo Test 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.

The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens, intended as an aid in early detection of pregnancy. It is for prescription use in clinical laboratories and not for point-of-care use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision/Reproducibility/Cut-Off Value Studies:
  • For serum (strip and cassette formats): 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to 10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 tests per hCG concentration. The results tables show 30 results (10 replicates x 3 operators) per lot, and thus 90 results per hCG concentration across the 3 lots.
  • For urine (strip and cassette formats): Similar to serum, 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to 10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 tests per hCG concentration. The results tables show 30 results (10 replicates x 3 operators) per lot, and thus 90 results per hCG concentration across the 3 lots.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be clinical laboratory settings given the intended use. These were spiked samples, not naturally occurring patient samples.
• High Dose Effect Study: Spiked negative urine/serum samples with 7 different high hCG concentrations. Tested by 3 different lots and 3 different operators. The number of replicates per concentration is not specified but the table shows a consistent positive result.
• Effects of hCG B-core fragment Study: Serum samples with 0mIU/mL and 10mIU/mL hCG were spiked with 14 different concentrations of B-core fragment. Urine samples with 0mIU/mL and 20mIU/mL hCG were spiked with the same B-core fragment concentrations. Tested by 3 different lots and 3 different operators. Number of replicates not specified.
• Effects of glycoprotein LH, FSH and TSH Study: Negative and positive samples (0 and 20 mIU/mL hCG for urine, 0 and 10 mIU/mL hCG for serum) were spiked with various concentrations of LH, FSH, and TSH. Tested by 3 different lots and 3 operators. Number of replicates not specified.
• Interference Study: Each of 19 interferents was spiked into hCG-free and hCG-positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked sample was tested using 3 different lots of the kit. Number of replicates not specified but results for all 3 lots are shown.
• Effect of Urine Specific Gravity and pH Study: Urine samples (negative and positive at 20 mIU/mL hCG) tested at 6 pH values (4-9). Urine samples (negative and positive at 5 and 20 mIU/mL hCG) tested at 5 specific gravity values (1.000-1.035). Tested using 3 different lots by 3 different operators. Number of replicates not specified.
• Comparison Studies:
  • 100 urine samples and 100 serum samples were collected from 100 women.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples were "collected from 100 women (about half of them were pregnant, early stage at less than 5 weeks)." This suggests prospective collection for the study.

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

• Precision/Reproducibility/Cut-Off Value Studies: The "ground truth" (i.e., expected positive/negative based on hCG concentration) was established by using commercially available hCG traceable to the 4th WHO international Standard. These were spiked samples, so the hCG concentration was known.
• Comparison Studies: Ground truth for the 100 urine and 100 serum samples was established by the "results from predicate devices (QVUE)". It's not explicitly stated that experts established the ground truth for these samples; rather, the predicate device served as the reference.
• Other Studies (Specificity, Interference, pH/Specific Gravity): Ground truth was based on the known spiked concentrations of hCG or interferents.

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

• Precision/Reproducibility/Cut-Off Value Studies, High Dose Effect, hCG B-core fragment, Glycoprotein hormones, Interference, pH/Specific Gravity: Data was collected by 3 different operators for each lot. The tables show the results from each individual lot, and then an "Overall Agreement" is calculated based on the total number of negative/positive results across the 3 lots. There is no explicit mention of an adjudication process (e.g., if operators disagreed).
• Comparison Studies: "Samples were tested by three different health professionals with the proposed and the predicate devices." It is not stated how discrepancies between the health professionals were resolved or if their readings were adjudicated. The summary tables combine results, implying an agreement or average.

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, this is not an MRMC comparative effectiveness study involving AI. It is a comparison study between a new device and a predicate device, using human readers for both. Therefore, no effect size of human readers improving with or without AI assistance is reported.

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

No, this device is a rapid visual immunoassay (test strip/cassette) intended to be interpreted visually by human users ("health professionals"). There is no algorithm or AI component, and thus no standalone algorithm-only performance was conducted or is applicable.

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

• For analytical performance metrics (precision, specificity, interference, pH/specific gravity), the ground truth was based on known spiked concentrations of hCG, interferents, or controlled pH/specific gravity levels. This is essentially a controlled laboratory standard.
• For the comparison studies, the ground truth was established by the predicate device (QuickVue One-Step hCG Combo test).

8. The sample size for the training set:

This device is not an AI/ML algorithm, so there is no "training set" in the conventional machine learning sense. The performance data presented are for verification and validation of the device's analytical and clinical performance.

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

As there is no AI/ML component, there is no "training set" or ground truth for a training set.

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Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows:

For prescription use in central laboratories only. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana, Cocaine, Phencyclidine, Morphine, Amphetamine, Benzodiazepines, and MDMA (Ecstasy) in human urine.

The provided document describes the Polymed Therapeutics' Fastep™ Dipstick and Dipcard Drugs of Abuse Screen Devices. Here's an analysis of the acceptance criteria and study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against its ability to detect specific drugs of abuse in human urine at defined cutoff concentrations. The performance is assessed by comparing its results to confirmed analytical methods (GC/MS and/or LC/MS) and a predicate device. While explicit "acceptance criteria" are not numerically stated in the provided text (e.g., "sensitivity must be >95%"), the reported performance indicates that it demonstrated "substantial equivalence" to the established confirmatory methods and predicate devices for all specified drugs. This "substantial equivalence" effectively serves as the acceptance criterion in the context of a 510(k) submission.

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

The document mentions "blind-labeled clinical specimen correlation study" and "blind-labeled spiked control studies." However, specific sample sizes for these test sets are not provided in the given text.

The data provenance is not explicitly stated. The term "clinical specimen" suggests human-derived samples, but their geographic origin (country) and whether they are retrospective or prospective are not mentioned.

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

The ground truth for the test set was established by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are analytical laboratory methods, not human expert evaluations for establishing ground truth in this context. Therefore, no human experts were used in this specific manner for ground truth establishment.

4. Adjudication Method for the Test Set

Since the ground truth was established by instrumental analytical methods (GC/MS/LC/MS), there was no adjudication method involving human experts for the test set. The analytical results from GC/MS/LC/MS are considered definitive.

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

There is no mention of an MRMC comparative effectiveness study in the document. This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers.

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

This device is an immunoassay that provides a qualitative result. It is inherently a "standalone" device in that its performance is judged on its own ability to detect the drugs without human-in-the-loop interpretation beyond reading the visual result (which is a standard part of such tests). The studies described ("clinical specimen correlation study" and "spiked control studies") evaluate the performance of the device itself.

7. The Type of Ground Truth Used

The type of ground truth used was confirmed analytical results from Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are objective, gold- standard laboratory methods for drug detection and quantification.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. Immunoassays like this are typically developed and validated using a series of experiments (which could be considered part of a broader development/training phase), but the specific terminology of "training set" as used in machine learning is not applicable here. The presented studies seem to focus on the validation/test phase of the device.

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

As no explicit "training set" is mentioned in the machine learning sense, the method for establishing its ground truth is also not described. If we consider the broader development process, the ground truth for establishing the performance characteristics of the assay (e.g., setting cutoffs, ensuring specificity) would also rely on confirmed analytical methods like GC/MS and LC/MS.

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The Polymed Therapeutics' Fastep™ At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy.

Polymed Therapeutics' FastepTM At-Home Pregnancy Test is intended to be distributed for Over-the-Counter (OTC) use.

Polymed Therapeutics' Fastep™ At-Home Pregnancy Test utilizes monoclonal antibody reagents to selectively detected elevated levels of hCG in urine specimen at the sensitivity of 20mIU/mL. It is designed to be tested in midstream and dipstick mode. The Fastep™ At-Home Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The result is generated by immersing the tip in the urine stream or urine cup for a sufficient amount of time to absorb an adequate sample volume. Each test reagent strip consists of a mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Acceptance Criteria and Study for Fastep™ At-Home Pregnancy Tests

Here's an analysis of the acceptance criteria and the study conducted for the Fastep™ At-Home Pregnancy Tests (K122907), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. However, it implicitly uses the performance of the predicate device (Teco Diagnostics One-Step Midstream Pregnancy Test, K974059) and confirmed hCG quantitative levels as benchmarks for substantial equivalence. The reported performance is as follows:

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

• Sample Size:

  • Main Accuracy (Consumer) Study: 148 lay users. The number of specimens isn't explicitly stated but would be at least 148 if each user tested one unique specimen. It is more likely that multiple users tested the same set of specimens.
  • Additional Lay User (Near-cutoff) Study: 21 laypersons. Again, the number of specimens isn't explicitly stated, but each layperson tested the "dipstick" mode.

• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they involved active participation by "lay users" performing tests and interpreting results.

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

• The ground truth for the test set was established through "confirmed hCG quantitative measurements." The document does not specify the number of experts involved in performing or interpreting these quantitative measurements, nor their specific qualifications (e.g., medical technologists, lab directors).

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for conflicting interpretations or results from the lay users. The "agreement" percentages are reported directly against the established ground truth (predicate device results or quantitative hCG levels). It implies a direct comparison rather than an adjudication process between multiple readers.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as described in the provided text. The studies focused on direct performance and agreement of the device, primarily with lay users, against a predicate device and quantitative lab results. There is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of this device.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance was done in the sense that the device's ability to detect hCG was assessed independently (against quantitative hCG levels) by lay users following instructions. However, it's crucial to understand that this is a chemical immunoassay device, not an AI algorithm. Therefore, "algorithm only" performance, as typically understood in AI/software domains, does not apply here. The "device performance" is its standalone performance without a human-in-the-loop, though human users perform the physical testing and interpretation.

7. Type of Ground Truth Used

• The primary ground truth used was quantitative hCG measurements of the urine specimens. This is a definitive laboratory method for determining the presence and concentration of hCG.
• For the main accuracy study, the results of the predicate device (Teco Diagnostics One-Step Midstream Pregnancy Test) were also used as a comparative benchmark, implying that the predicate's results were considered a form of "ground truth" for comparison purposes.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable here as this is a chemical immunoassay device, not a machine learning or AI-based system that requires a training set.

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

• As there is no training set, this question is not applicable.

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The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only. The test kits are for health care professionals use including professionals at physician's office labs (POLs) and Point-of-Care site (POC).

The Fastep™ hCG Pregnancy Serum/Urine Test are distributed in Cassette format. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-B-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Here's a breakdown of the acceptance criteria and study information for the Fastep™ hCG Pregnancy Serum/Urine Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= 95%"). Instead, it compares the device's performance to a predicate device (Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test) and declares "substantial equivalency." However, we can infer the performance metrics considered acceptable based on the reported results and the statement of substantial equivalency.

• Serum: 96.9% Positive, 3.1% Negative
• Urine: 96.9% Positive, 3.1% Negative
  (100% agreement for negative and higher positive concentrations) |
  | Interference | Performance not affected by specified pH, specific gravity, or presence of common substances (e.g., Acetaminophen, Albumin, Glucose). | Performance not affected by urine pH 3.0-8.5, specific gravity 1.00-1.03, or specified concentrations of 15 common substances. |

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

• Sample Size: 145 clinical specimen sets (referring to the combined urine and serum sets for accuracy correlation studies).
  • Urine: 145 samples (59 positive, 86 negative)
  • Serum: 145 samples (59 positive, 86 negative - derived from the 58 positive, 1 negative, 86 negative results)
• Data Provenance: Not explicitly stated as retrospective or prospective, nor is the country of origin specified beyond "clinical specimens." It's implied these are human clinical samples (urine and serum). The "POLs site study" suggests some data collected from Physician's Office Labs, which would be clinical settings.

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

• The 510(k) summary does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

• The 510(k) summary does not explicitly state an adjudication method. For the accuracy studies, the clinical serum specimens were "quantitatively confirmed by Abbott Architect i2000 instrument." This implies the Abbott Architect i2000 results served as the reference standard for the clinical specimens.

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. This device is a rapid chromatographic immunoassay, which is a point-of-care test, not an AI-powered diagnostic imaging or interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• Yes, effectively. This device is the standalone "algorithm" (biochemical reaction and visual interpretation) for detecting hCG. Its performance metrics (sensitivity, specificity, precision, cross-reactivity, interference) are all measures of its standalone capability to detect hCG in samples and provide a visual result. The "human-in-the-loop" aspect is the visual reading by a healthcare professional, but the performance data presented is for the device's ability to produce the correct positive/negative signal.

7. The Type of Ground Truth Used

• For the accuracy studies (clinical specimens): The ground truth for hCG concentration was established by quantitative confirmation using the Abbott Architect i2000 instrument (predicate device K093318). This is a well-established laboratory instrument for quantitative hCG measurement.
• For sensitivity, cross-reactivity, precision, and interference studies: The ground truth was established using known concentrations of hCG (e.g., 0 mIU/ml, 10 mIU/ml, 15 mIU/ml, 20 mIU/ml, 40 mIU/ml, 100 mIU/ml) and known concentrations of interfering substances, often in "spiked" samples. This represents a form of analytical gold standard or controlled experimental conditions.

8. The Sample Size for the Training Set

• This information is not provided in the 510(k) summary. For in vitro diagnostic (IVD) devices like this, the concept of a "training set" in the context of machine learning (where data is used to train an algorithm) is not directly applicable. The device's components (antibodies, reagents) are developed and optimized through R&D, and then validated with test sets.

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

• As mentioned above, the concept of a "training set" as commonly understood in AI/machine learning doesn't directly apply here. For the development and optimization of the test, the "ground truth" would have been established through well-characterized reference materials, known concentrations of hCG, and thorough analytical testing during the R&D phase to ensure the antibodies and test format functioned as intended. The 510(k) summary describes the validation testing, not the development process.

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