Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device