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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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