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The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.

The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.

The hCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.

The hCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.

The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by added urine sample and obtaining the result from the colored lines.

The tests will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic card, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum foil pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum foil pouch, Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.

The provided text describes the analytical and clinical performance of the HCG One Step Pregnancy Test Strip and Midstream (OTC and Rx) devices. It includes a comparison to a predicate device and a lay-user study.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of numerical values for all performance metrics. However, it does present performance results demonstrating the device's capabilities, which implicitly serve as the achieved criteria. The primary analytical acceptance criterion seems to be a sensitivity of 25 mIU/mL HCG and 100% agreement in clinical studies.

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

• Analytical Performance Test Set Sizes:

  • Precision/Reproducibility/Sensitivity: For each device format (Strip, Midstream immersion, Midstream urinate), 90 replicates were tested at each-described HCG concentration (0, 12.5, 18.75, 25, 37.5, 50, 100 mIU/mL).
  • Cross-Reactivity: For each candidate device format, n=15 for each concentration of cross-reactivity substance (LH, FSH, TSH) in each HCG level sample (0, 25, 100 mIU/mL).
  • Interference Study: For each device format, 15 replicates were tested for each interferent in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
  • HCG β-core fragment Effect: For each device format, 15 replicates were tested at each concentration of β-core fragment (62500, 125000, 50000, 1000000 pmol/L) in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
  • Urine pH Effect: For each device format, 15 replicates were tested at various pH values (4.0, 5.0, 6.0, 7.0, 8.0, 9.0) in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
  • Urine Specific Gravity Effect: For each device format, 15 replicates were tested at various specific gravity values (1.000, 1.025, 1.026, 1.026, 1.031, 1.035) in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
  • High Dose Hook Effect: For each device format, 15 replicates were tested at HCG concentrations up to 2000 IU/mL.
  • Read Time Flex, Temperature Flex, Sample Volume Flex, Sample Storage Study, Sample Container Material Study: Typically 5 replicates per condition for each device format.

• Clinical (Method Comparison) and Lay-User Test Set Sizes:

  • Method Comparison: 330 women's urine samples.
    • Strip Format: 110 samples.
    • Midstream Immersion: 111 samples.
    • Midstream Urinate: 109 samples.
  • Lay-User Study: 330 volunteers.
    • HCG One Step Pregnancy Test Strip OTC: 110 lay-users.
    • HCG One Step Pregnancy Test Midstream OTC: 220 lay-users (111 for Immersion, 109 for Urinate).

• Data Provenance:

  • The document does not explicitly state the country of origin for the clinical samples or the analytical studies. However, the manufacturer is "Hangzhou Aichek Medical Technology Co., Ltd." in China, suggesting the data may originate from China or be collected through international collaborations.
  • All clinical data appears to be prospective, collected during the method comparison and lay-user studies. The analytical studies use spiked urine samples.

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

• Analytical Studies: Ground truth for analytical studies (e.g., HCG concentrations, interferent concentrations) was established by spiking known quantities of substances into urine samples. No external experts are mentioned for establishing ground truth here beyond the scientific method of solution preparation.
• Clinical (Method Comparison) Study: The ground truth was established by comparing the candidate device results to a predicate device (One Step HCG Urine Pregnancy Test - K043443). The laboratory professionals at the three point-of-care (POC) sites who performed the predicate device testing (and verified results for the lay-user study) effectively served as the "experts" for ground truth, though their specific qualifications (e.g., years of experience, specific roles) are not detailed beyond "professional testing." There were 9 different professionals in total (3 at each of 3 sites).

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

• The document does not describe any formal adjudication method (like 2+1 or 3+1) for resolving discrepancies between readers or devices.
• For the method comparison and lay-user studies, the comparison is directly between the candidate device's result and the predicate device's result (for method comparison) or the professional's result (for lay-user study), which implicitly serves as the ground truth without further adjudication described. Since 100% agreement was reported, no discrepancies needing adjudication were observed or reported.

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 MRMC comparative effectiveness study was done. This device is a diagnostic test kit (pregnancy test) and not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable.
• The study involved multiple professionals (9 across 3 sites) comparing the candidate device to a predicate device, and multiple lay-users. This is a multi-reader study in a sense, but not an MRMC study designed to assess AI assistance.

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

• This question is not applicable to HCG One Step Pregnancy Test Strips/Midstreams, as they are manual diagnostic tests with a human visually interpreting the result. They do not involve an algorithm or AI.

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

• Analytical Studies: The ground truth for analytical studies was established by spiking known concentrations of HCG or interfering substances into negative pooled human urine samples.
• Clinical Studies (Method Comparison & Lay-User): The ground truth was established by the results obtained from the legally marketed predicate device (One Step HCG Urine Pregnancy Test - K043443), interpreted by laboratory professionals. This serves as a reference standard rather than pathology or outcomes data.

8. The sample size for the training set

• This information is not applicable. The HCG One Step Pregnancy Test is a lateral flow immunoassay, not a machine learning or AI-based device that requires a "training set" in the context of algorithm development.

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

• This information is not applicable, as there is no "training set" for this type of device.

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The hCG One Step Pregnancy Test is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin hormone in human urine samples. It is used 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.

The hCG One Step Pregnancy Test is a lateral flow sandwich immunochromatographic assay for the qualitative determination of human chorionic gonadotropin (hCG) in human urine samples.

This report describes the acceptance criteria and the study that proves the device, the hCG One Step Pregnancy Test, meets those criteria.

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report typically associated with AI/ML-based devices. Therefore, some of the requested information, particularly regarding ground truth establishment by experts, adjudication, and MRMC studies, is not explicitly detailed as this device is a qualitative lateral flow immunoassay, not an AI-assisted diagnostic.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through analytical performance studies (Limit of Detection, Precision/Reproducibility, Analytical Specificity) and a comparison study to a legally marketed predicate device.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Limit of Detection: The panel was created by spiking 30 negative urine samples with hCG. The number of individual test runs was significantly higher, as 3 lots of the device were tested by 3 lab technicians on different days, with randomized, blind-coded panel members. The specific total count of test runs is not provided but is a multiple of 30.
  • Precision/Reproducibility: Twenty replicates of each spiked urine sample (concentrations 0, 5, 7.5, 8.75, 10, 12.5, and 25 mIU/mL) were tested in one day for repeatability. For intermediate precision, 450 replicates per urine sample concentration were tested (10 replicates per operator x 3 operators x 3 lots x 5 nonconsecutive days).
  • Analytical Specificity (Interfering Substances): Five devices were used for testing each interfering substance.
  • Method Comparison: A total of 158 urine samples from 158 subjects.
• Data Provenance:
  • The document does not explicitly state the country of origin for the clinical urine samples.
  • The studies appear to be prospective as per standard FDA premarket notification requirements for device testing. The "urine samples were collected at various times of day in a random fashion" and "masked with a code and randomized by individuals who were not conducting the test," suggesting a structured study design.

3. Number of Experts and Qualifications for Ground Truth

• This information is not explicitly detailed in the document.
• For this type of qualitative immunoassay (pregnancy test), the "ground truth" for the test set is established by the presence or absence of hCG in the urine samples at specified concentrations, verified through the spiking process using traceable hCG standards (5th WHO international Standard) and comparison to a predicate device.
• The interpretation of the device results during testing was performed by "lab technicians" for analytical studies and "professional users" for the comparison study. Their specific qualifications (e.g., years of experience, specific medical background) are not provided, but these roles imply trained personnel capable of accurately performing and interpreting the test. No expert radiologists or similar specialists are required for this device type.

4. Adjudication Method for the Test Set

• Not applicable/Not explicitly stated in the context of expert adjudication.
• For the analytical studies (LOD, Precision), the ground truth is based on the known concentration of hCG in the spiked samples. The device's performance is then measured against this known concentration.
• For the method comparison study, the comparison is made against the results of the legally marketed predicate device. Discrepancies (if any, though 100% concordance was reported) would likely prompt re-evaluation of the sample or test, rather than a formal expert adjudication process as seen in imaging studies. The samples were "masked with a code and randomized by individuals who were not conducting the test," which helps prevent bias in interpretation.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with AI/ML-based diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
• The hCG One Step Pregnancy Test is a qualitative immunoassay, where the result is visually interpreted (presence/absence of a line). The "performance" is about whether the line appears correctly for a given hCG concentration, not about optimizing human interpretation of complex data.
• While multiple operators (lab technicians, professional users) were involved in testing to demonstrate reproducibility and comparability, this is distinct from an MRMC study assessing AI-assisted human reader improvement.

6. Standalone Performance (Algorithm Only)

• Yes, in essence, the device's performance is standalone.
• The hCG One Step Pregnancy Test is a non-AI, non-software-based diagnostic device. Its performance (e.g., sensitivity, specificity, limit of detection) is inherent to its physical and chemical properties and is evaluated directly through the analytical and comparison studies.
• There is no "algorithm only" component separate from the physical test strip and its reagents. The results are based on the immunochromatographic reaction itself.

7. Type of Ground Truth Used

• Analytical Ground Truth (for LOD, Precision, Analytical Specificity): Based on known concentrations of hCG in spiked urine samples, traceable to the 5th WHO international Standard. This is a highly controlled and quantitative ground truth.
• Comparative Ground Truth (for Method Comparison): The results from a legally marketed predicate device (First Response Early Result Pregnancy Test) using the same clinical urine samples. This establishes equivalence to an accepted standard.

8. Sample Size for the Training Set

• Not applicable/Not provided. This device is not an AI/ML device that requires a distinct "training set." Its chemical and biological components are designed and manufactured, not "trained" on data. The studies described are for validation and verification of the finished product's performance.

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

• Not applicable. As stated above, there is no training set for this type of medical device.

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The SEIOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The SEJOY hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

The SEJOY hCG One Step Pregnancy Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Sejoy HCG One Step Pregnancy Test will be sold in three different formats:Strip,Cassette,and Midstream.The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device,a disposable plastic dropper,and a package insert.

The provided document is a 510(k) summary for the SEJOY hCG One Step Pregnancy Test, a medical device for qualitative detection of hCG in urine. It details the device's performance characteristics, including analytical performance and method comparison studies.

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific positive/negative compliance rate targets for a combined "test set" in the way a rigorous AI/ML performance study might. Instead, it presents performance data from multiple analytical and comparative studies. However, for a qualitative test like this, the implicit acceptance criteria are generally 100% agreement for negative and sufficiently high agreement (often 95% or higher) for positive cases, especially at and above the claimed sensitivity. The performance tables demonstrate this.

Here’s a summary of the relevant performance data, interpreted as meeting implicit acceptance criteria:

Device Performance Summary (Based on provided data):

Detailed Performance Tables from the text (Acceptance Criteria met where "100%"):

Analytical Performance (Precision/Reproducibility/Sensitivity) - Combined Operator Data:

Strip Format: Operator 1&2&3

Cassette Format: Operator 1&2&3

Midstream Format: Operator 1&2&3

Method Comparison Study (N agreement with predicate device):

• Strip Format: Positive: 78/78 (100%), Negative: 72/72 (100%)
• Cassette Format: Positive: 78/78 (100%), Negative: 72/72 (100%)
• Midstream Format (dip): Positive: 63/63 (100%), Negative: 72/72 (100%)
• Midstream Format (simulate stream): Positive: 63/63 (100%), Negative: 72/72 (100%)

Lay Person Study (N agreement with professional results):

• Strip Format: Positive: 46/46 (100%), Negative: 64/64 (100%)
• Cassette Format: Positive: 44/44 (100%), Negative: 66/66 (100%)
• Midstream Format (dip): Positive: 42/42 (100%), Negative: 68/68 (100%)
• Midstream Format (simulate stream): Positive: 45/45 (100%), Negative: 65/65 (100%)

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

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • Sample Size: For each format (Strip, Cassette, Midstream), and for each hCG concentration (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 3 different lots were tested. For each lot and concentration, 3 operators performed tests, with 2 runs per day for 15 days. This means for each operator, lot, and concentration, 30 replicates were performed (2 runs/day * 15 days = 30).
  • Total replicates per hCG concentration per format: 3 lots * 30 replicates/lot/operator * 3 operators = 270 replicates.
  • Total replicates across all concentrations for one format: 8 concentrations * 270 replicates = 2160 replicates.
  • Data Provenance: Not explicitly stated, but given the company is based in China (Hangzhou), the testing was likely conducted in China. The study is prospective as it involves controlled spiking of urine samples and systematic testing.

• Method Comparison Study (Clinical Performance in real samples):

  • Sample Size:
    • Strip and Cassette formats: Urine samples from 150 women. Approximately half (around 75) were suspected to be pregnant.
    • Midstream format: Urine samples from 135 women. Approximately half (around 67 or 68) were suspected to be pregnant.
  • Data Provenance: Not explicitly stated for the source of these patient samples. Implied to be clinical samples from patients presenting for pregnancy testing. The study design (comparing device to a predicate at POC sites) suggests a prospective clinical study.

• Lay Person Study:

  • Sample Size: 440 women.
  • Data Provenance: Not explicitly stated, but it describes "women's individual pregnancy status was self-tested, varying educational and occupational backgrounds were chosen for the study." This implies a prospective study involving real users.

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

• Analytical Performance: The ground truth for spiked samples (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL) is intrinsically defined by the known hCG concentrations. The hCG standard is "Traceable to the 5th WHO," indicating a robust and internationally recognized standard. The device's reading sensitivity is 25 mIU/mL. Human "experts" are not needed to establish this ground truth, as it's a precisely formulated laboratory experiment.
• Method Comparison Study: The ground truth for the clinical samples was established by the predicate device (CLUNGENE HCG Pregnancy Rapid Test, K193132). The study aimed to show conformity with this established method. "Three different health professionals for each format at the 3 POC sites for a total of 12 POC operators" were involved in testing the samples with both the proposed and predicate devices. Their qualifications (e.g., specific medical titles, years of experience) are not detailed, but they are referred to as "health professionals."
• Lay Person Study: The ground truth for the lay person study was "professional testing." This professional testing served as the reference standard against which the lay person's self-test results were compared. The specific qualifications of these "professionals" are not detailed.

4. Adjudication Method for the Test Set:

• Analytical Performance: No adjudication method as the ground truth is based on precise spiked concentrations. Results are reported directly based on optical interpretation of the test strips.
• Method Comparison Study: Not explicitly stated. However, given that multiple "health professionals" at "3 POC sites" tested the samples, it is implied that the results were compared directly between the proposed device and the predicate device. If there were discrepancies, the document does not describe a formal adjudication process (e.g., by a third, blinded reader). The results simply state 100% conformity, suggesting no discrepancies or that any discrepancies were resolved in a non-specified manner.
• Lay Person Study: Not explicitly stated. The lay person's self-test results were compared to "professional testing." It's implied that discrepancies (if any) would highlight issues with lay user interpretation. The reported 100% conformity suggests no discrepancies between lay user and professional results.

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:

This device is a simple, qualitative immunoassay (lateral flow test), not an AI/ML-driven diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable to this device. The studies were designed to confirm the device's accuracy against known concentrations, a predicate device, and lay user interpretation.

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

This is not a software-based AI algorithm. The device is a physical test strip/cassette/midstream that provides a visual reading (presence or absence of control and test lines). Its "performance" is inherently tied to the chemical reaction and the visual interpretation, whether by an operator (analytical/method comparison studies) or a lay person (lay person study). There is no "algorithm only" component that would perform independently of human interaction or a physical sample.

7. The Type of Ground Truth Used:

• Analytical Performance: Known, precisely titrated hCG concentrations (traceable to WHO International Standard 5th edition). This is a strong, objective ground truth for analytical sensitivity.
• Method Comparison Study: Predicate device results (CLUNGENE HCG Pregnancy Rapid Test, K193132). This is a comparative "gold standard" for regulatory purposes, showing equivalence to an already approved device.
• Lay Person Study: Professional testing results. This acts as the "gold standard" for the interpretation study, ensuring that device performance under lay use conditions is objectively assessed against trained personnel.

8. The Sample Size for the Training Set:

This document describes a K-number premarket notification for a medical device (hCG pregnancy test) that is based on a chemical immunoassay, not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" as would be relevant for an AI/ML model. The studies described are for validation and performance testing of the physical device.

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

As there is no training set for this type of device (non-AI/ML), this question is not applicable. The ground truth for the test and validation studies (as described in point 7) was established through known concentrations, predicate device results, and professional testing.

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The Healgen hCG One Step Pregnancy Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

The Healgen hCG One Step Pregnancy Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

Not Found

The provided document is an FDA 510(k) clearance letter for the Healgen hCG One Step Pregnancy Test Strip and Cassette. It confirms substantial equivalence to a predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a scientific publication.

Therefore, I cannot fully answer your request with the input provided. However, I can infer some aspects based on common FDA requirements for such devices.

Here's what can and cannot be answered based on the provided text:

What can be extracted:

• Device Name: Healgen hCG One Step Pregnancy Test Strip, Healgen hCG One Step Pregnancy Test Cassette
• Indications for Use: Rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, for Over-The-Counter self-testing use.
• Type of Test: In vitro diagnostic visual qualitative immunochromatographic assay.

What cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. It would be in the detailed device performance section of the 510(k) submission. Acceptance criteria for pregnancy tests typically include sensitivity (limit of detection, analytical sensitivity), accuracy (agreement with a reference method), and sometimes precision.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. For an OTC pregnancy test, ground truth is usually based on a quantitative lab reference method for hCG.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Highly unlikely for a qualitative, visually read OTC pregnancy test. This type of study is more common for imaging devices or algorithms that interpret complex data. The performance would be assessed against a quantitative standard, not typically human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a visual qualitative assay, meaning a human reads the result directly. It's not an algorithm.
7. The type of ground truth used: For a pregnancy test, the ground truth for hCG detection is typically established by a quantitative laboratory method (e.g., quantitative serum or urine hCG assay) to determine the precise hCG concentration.
8. The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" or "AI" that requires a training set in the conventional sense for a visual immunochromatographic assay.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

To obtain this detailed information, one would need to review the actual 510(k) submission (if it's publicly available and unredacted) or scientific publications related to the device's validation.

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CareStanTM hCG One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a pregnancy test, which states that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Device Name: CareStart™ hCG One-Step Pregnancy Test and CareStart Plus - hCG One-Step Pregnancy Test
• Regulation Number: 21 CFR 862.1155 (Human chorionic gonadotropin (HCG) test system)
• Intended Use: Qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, intended for use by health care professionals.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. Information about any MRMC comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This kind of detailed study information is typically found in the "Summary of Safety and Effectiveness" or a similar document that would have been submitted as part of the 510(k) application, but it is not present in the provided FDA clearance letter itself.

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ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. This test is for professional use.

ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Test Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

Here's a breakdown of the acceptance criteria and study details for the ACON™ hCG One Step Pregnancy Test Device (Urine), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 159 urine specimens.
• Data Provenance: The document states "A multi-center clinical evaluation was conducted," implying the data was collected from multiple locations. It does not explicitly state the country of origin, but the submission is to the US FDA, and the company is based in San Diego, CA, USA, suggesting it's likely US-based or international data submitted for US approval. The study appears to be prospective in comparing the new device against a predicate.

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

• The document describes a comparative study against "another commercially available urine membrane test." The results of this predicate device were used as the comparator, essentially serving as a surrogate for ground truth.
• The number of experts involved in determining the "truth" for the predicate device's results is not specified. The qualifications of anyone interpreting the predicate device's results are also not specified.

4. Adjudication Method for the Test Set:

• The text describes a direct comparison: "comparing the results obtained using ACON™ hCG One Step Pregnancy Test Device (Urine) and another commercially available urine membrane test."
• There is no mention of an adjudication method (e.g., 2+1, 3+1) because the comparison is directly between the new device and an established predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. The study's design was a direct comparison of the new device's performance against a predicate device, not an evaluation of how human readers improve with or without AI assistance. The device itself is a diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, a standalone study was done. The ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay. Its performance, as reported in the study, refers to the device's ability to detect hCG independently, without human interpretation beyond reading the lines on the test strip according to instructions. The comparison is the device's output against the predicate device's output.

7. The Type of Ground Truth Used:

• The "ground truth" for the comparative study was based on the results obtained from another commercially available urine membrane test (predicate device). This serves as a clinical reference or comparator standard.
• In terms of the device's intrinsic capabilities (sensitivity and specificity testing), the ground truth for sensitivity was based on known hCG concentrations (25 mIU/ml) standardized to the World Health Organization Third International Standard, and for specificity, it was based on known concentrations of interfering hormones.

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. This type of immunoassay device is typically developed and validated through laboratory testing and then clinical evaluation, rather than through a machine learning paradigm that relies on distinct training and test sets in the same way. The 159 urine specimens were the test set for clinical performance.

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

• As a traditional immunoassay, the concept of a "training set" and associated "ground truth" derived from expert consensus or pathology, etc., is not applicable in the same way it would be for AI/machine learning algorithms.
• The development and calibration of such a device primarily involve optimizing antibody-antigen reactions, membrane characteristics, and visual signal development to achieve desired sensitivity and specificity targets in laboratory settings, often using controlled samples with known hCG concentrations. The "ground truth" in this context would be the precisely measured hCG concentrations in spiked samples or reference materials used during assay development and calibration.

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Immunoassay for in vitro diagnostic use in hospital, physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in urine for the early confirmation of pregnancy.

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I am sorry, but the provided text does not contain the detailed information needed to fill out all the sections of your request about acceptance criteria and study particulars for the BioSign™ hCG-One Step Pregnancy Test. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not typically include the nitty-gritty details of the studies conducted to demonstrate performance.

Here's what I can and cannot extract from the given text:

Information I CANNOT extract from the document:

• Acceptance Criteria Table and Reported Device Performance: This document does not specify exact acceptance criteria or detailed performance metrics like sensitivity, specificity, accuracy, or reported values from a study.
• Sample Size (Test Set) and Data Provenance: This information is not present.
• Number of Experts and Qualifications: Not mentioned in this regulatory letter.
• Adjudication Method: Not specified.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study and its results are not discussed.
• Standalone Performance: While the device is "one-step," the specific details of a standalone performance study with metrics are not included.
• Type of Ground Truth Used: The method for establishing ground truth (e.g., pathology, expert consensus) is not detailed.
• Sample Size (Training Set): Not provided.
• How Ground Truth for Training Set was Established: Not provided.

What I can infer/extract at a high level:

• Device Name: BioSign™ hCG-One Step Pregnancy Test
• Indications for Use: Immunoassay for in vitro diagnostic use in hospitals and physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) for the early confirmation of pregnancy.
• Ground Truth (Indirect Inference): For a pregnancy test, the ground truth would typically be established by a reference method for hCG detection (e.g., a laboratory quantitative hCG assay) or confirmed clinical pregnancy outcomes, but the document doesn't explicitly state which was used.
• Regulatory Context: This is a 510(k) premarket notification, indicating the device was cleared based on substantial equivalence to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics, or if different, that the differences do not raise new questions of safety or effectiveness. Performance data would have been submitted to support this claim, but those details are not in this letter.

To get the information you requested, you would typically need to refer to the 510(k) submission summary or detailed performance data submitted by Princeton BioMeditech Corporation to the FDA, which is not part of this clearance letter.

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An hCG pregnancy test intended for over the counter use by lay persons is an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (hCG), a human hormone, in urine. Measurements that are obtained by this device are used in the diagnosis of pregnancy.

Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Detection of Early Pregnancy. The QuickCard HCG One Step Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.

Here's a breakdown of the acceptance criteria and study information for the QuickCard HCG One Step Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for sensitivity, specificity, or accuracy. Instead, it describes performance in relation to substantial equivalence to predicate devices and "excellent" results in a lay-user study.

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

• A specific, single "test set" sample size for the clinical correlation study is not explicitly stated. It refers to "clinical specimens" and "correlation studies."
• For the blind labeled spiked consumer study (lay-user study):
  • Sample Size: Not explicitly stated as a single number of participants. The results (122/123 sensitivity, 122/123 specificity, 244/246 accuracy) suggest a total of 246 cases were evaluated (123 positive detections and 123 negative detections if perfectly balanced, or some combination leading to 246 total readings). The "Most participants received a set containing 1 coded positive sample and 1 coded negative sample. One participant received 2 coded negative samples" suggests a minimum of 123 participants, with at least one receiving two negative samples, and others receiving one positive and one negative.
  • Data Provenance: The consumer study was conducted "at five geographically distinct locations" within the USA. It used "coded specimens," which implies a prospective study design where participants were given samples to test.

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

• The text does not specify the number or qualifications of experts for judging the reference methods in the clinical correlation study (Quidel RapidVue and Syntron Bioresearch Be Sure Pregnancy Test).
• For the lay-user study:
  • Ground Truth: The "coded urine samples" were "prepared as follows: Samples 1 and 3 were normal pooled male urine samples spiked to 40 mIU/mL hCG (WHO 1st IRP). Samples 2 and 4 were 0 mlU/mL hCG." This indicates laboratory-prepared samples with known hCG concentrations.
  • Experts: No external experts were used to establish the ground truth for these specific samples; the ground truth was established by the deliberate spiking or absence of hCG by the study designers.

4. Adjudication Method for the Test Set

• The text does not mention an adjudication method for either the clinical correlation study or the lay-user study.
• For the lay-user study, the design involved individuals following instructions and potentially recording their own interpretations, which were then compared against the known ground truth of the spiked samples. There is no indication of a separate expert review or adjudication of the lay users' interpretations described.

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

• No, a traditional MRMC comparative effectiveness study that measures the improvement of human readers with AI vs. without AI assistance was not done.
  • The device is a standalone immunoassay for qualitative detection of HCG, not an AI system designed to assist human readers in interpreting images or data.
  • The "consumer survey" involved lay users performing and interpreting the test themselves, which is a form of human performance, but not in the context of assisting professional readers.

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

• Yes, in essence, the "Performance" section describes the standalone performance of the device itself. The device is designed to be self-interpretable (visual color change) by a human user (either clinical professional or lay person).
  • The "clinical sample correlation study" assesses the device's outcome against other commercial tests, which can be seen as a standalone comparison.
  • The "blind labeled spiked consumer study" assesses the device's ability to accurately detect hCG in known positive/negative samples when interpreted by lay users, essentially testing the device's performance characteristics in the hands of its intended user without further professional intervention beyond the interpretation of the test result.

7. The Type of Ground Truth Used

• For the clinical correlation study: The ground truth was established by the results of two other commercially available and established pregnancy tests (Quidel RapidVue and the Syntron Bioresearch Be Sure Pregnancy Test).
• For the lay-user study: The ground truth was based on laboratory-prepared samples with known, controlled concentrations of hCG (40 mIU/mL hCG for positive samples and 0 mIU/mL hCG for negative samples). This is a form of spike-in ground truth.

8. The Sample Size for the Training Set

• The text does not mention a training set. This device is an immunoassay (a chemical test), not an AI algorithm that requires a training set. The "samples" referred to in the performance studies are for validation of the device's performance, not for training a model.

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

• As there is no mention of a training set for an AI algorithm, this question is not applicable based on the provided text.

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