Search Results

The AZOG hCG One-Step (Urine) Pregnancy Home Test (DipStick, Cassette and Midstream) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy at home.

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Midstream) are intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. The Test is for the early detection of pregnancy.

The AZOG hCG One-Step Urine Pregnancy Home Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early 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 adding urine into the sample well of the device and observing 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 to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AZOG, Inc. hCG One-Step Urine Pregnancy Home Test:

Acceptance Criteria and Device Performance

Study Details

This document primarily describes correlative and analytical studies, not a clinical effectiveness study.

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

• Correlation Study: 310 urine specimens.
• Assay Precision/Tolerance, Sensitivity, Specificity, Interference Studies: The document refers to "a panel of 3 coded specimens" for precision testing (negative, low positive, high positive) and does not specify a separate sample size for the sensitivity, specificity, and interference studies, but implies these were conducted in a laboratory setting using controlled samples.
• Data Provenance: Not specified, but the context of an FDA 510(k) submission suggests in-house laboratory testing rather than data from diverse countries or retrospective patient cohorts from clinics. These are likely prospective, controlled laboratory studies.

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

• Correlation Study: The "ground truth" for the correlation study was established by results obtained from a "similar device" (a legally marketed predicate device). No experts are explicitly mentioned for ground truth establishment for this comparison.
• Analytical Studies (Sensitivity, Specificity, Interference): The "ground truth" for these analytical studies was based on the known concentrations of hCG, LH, FSH, TSH, and interfering substances in the prepared samples. This does not involve human expert interpretation of results.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) is mentioned, as these studies primarily involve direct comparison to reference methods or known concentrations, rather than human interpretation requiring consensus.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The studies focused on the analytical performance of the device and its correlation with a similar existing device. There is no information about human readers or their improvement with or without AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Yes, the studies described are essentially standalone performance studies for the device (an immunoassay, not an algorithm in the AI sense). The device's performance, such as its ability to detect hCG at a certain level, its specificity, and its agreement with another device, is evaluated without human interpretation influencing the device's direct output. The test itself provides a visual result (colored lines) that a user then interprets.

7. The Type of Ground Truth Used

• Correlation Study: The "ground truth" was the results obtained from a similar legally marketed predicate device.
• Sensitivity, Specificity, and Interference Studies: The "ground truth" was based on known, controlled concentrations of the target analyte (hCG) and other substances (LH, FSH, TSH, interfering substances) in the prepared urine specimens. These are laboratory-derived ground truths.

8. The Sample Size for the Training Set

• The document does not specify a training set sample size. This is common for traditional immunoassay device submissions, as the "training" (development and optimization) of such devices often involves iterative lab testing and formulation adjustments rather than a distinct, quantifiable "training set" like in machine learning. The studies described are for validation of the finalized device.

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

• As a training set is not explicitly mentioned in the context of this traditional immunoassay device, the method for establishing its ground truth is also not detailed. The development process would have involved establishing the analytical accuracy of different formulations and reagent concentrations against known hCG standards to optimize the device's performance characteristics.

Ask a specific question about this device

The AZOG hCG One-Step (Urine) Pregnancy Test Strip (DipStick) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

AZOG, INC. ACG one-step. Vrine Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine the test is for professional use only.

The AZOG hCG One-Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early 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 immersing the test strip in a urine specimen and observing 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 to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

Here's a breakdown of the acceptance criteria and study details for the AZOG,Inc. Urine Pregnancy Test Strip:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 150 urine specimens were used for the correlation study.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "a panel of 3 coded specimens" for precision/tolerance and "150 urine specimens" for correlation. Given the nature of a pregnancy test, these would typically be human urine samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or not specified. For this type of device, the "ground truth" is typically established by comparing its results to a known reference method or a predicate device, rather than expert interpretation of images or clinical data.
• Qualifications of Experts: Not applicable, as expert consensus was not the primary method for ground truth establishment.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the correlation study was established by comparing the device's results to those obtained from a "similar device," implying either a predicate device or a well-established laboratory method. There was no mention of multiple human readers or a need for adjudication.

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

• MRMC Study Done: No. This type of study (MRMC) is typically performed for imaging diagnostic devices where human interpretation plays a significant role and AI aims to assist or replace human readers. The AZOG hCG One-Step Urine Pregnancy Test Strip is a rapid immunoassay that provides a direct qualitative result, not requiring a human interpretation loop in the same way.
• Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, essentially. The stated performance metrics (100% overall agreement, 99% accuracy, sensitivity, specificity, cross-reactivity, interference, precision) reflect the standalone performance of the device itself (the "algorithm" in a chemical assay context) reacting with urine samples. The device is designed to provide a direct readout without requiring human intervention for result interpretation beyond observing the colored lines.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Correlation Study: Comparison to results obtained from a "similar device" (likely a legally marketed predicate device or a validated laboratory method).
  • Sensitivity: Defined by the ability to detect a specific concentration of hCG (25 mIU/mL or greater) in spiked samples. This is a form of analytical ground truth.
  • Cross-Reactivity/Interference: Determined by testing known concentrations of interfering substances with negative and positive hCG samples. This is also analytical ground truth.
  • Precision/Tolerance: Established by testing coded specimens with known hCG levels (negative, low positive, high positive). This involves using known spiked/controlled samples as ground truth.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The device's performance is based on its chemical and biological components, which are developed and optimized through laboratory testing, rather than an AI algorithm trained on a dataset.

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

• Ground Truth for Training Set: Not applicable in the context of an AI training set. The development and optimization of the immunoassay (analogous to "training") would involve internal validation using known concentrations of hCG, potentially spiked with interferents, and comparison to established reference methods or predicate devices to ensure the assay components (antibodies, membrane, reagents) function as intended. This would involve a continuous process of testing and refinement during product development.

Ask a specific question about this device

The AZOG hCG One-Step (Urine) Pregnancy Test (Device or Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
AZOG, INC. hCG One-Step Urime Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine The test is for professional use only.

The AZOG hCG One-Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early 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 adding urine into the sample well of the device and observing 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 to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 150 urine specimens were used for the correlation study. For the precision/tolerance study, a panel of 3 coded specimens (negative, low positive, and high positive) were tested.
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective, as they involve testing the device with specific specimens to evaluate its performance.

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

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. For the correlation study, the "ground truth" was established by comparing the results of the AZOG device to a "similar device," implying that the similar device's results were considered the reference.

4. Adjudication Method for the Test Set

The document does not detail an adjudication method. For the correlation study, it was a direct comparison of results to a "similar device." For precision, it was an assessment of consistency across runs and operators.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the device and its agreement with a predicate device.

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

Yes, a standalone performance study was done. The document describes the device's ability to detect hCG, its sensitivity, specificity, precision, and freedom from interference, all of which are characteristics of the device's inherent performance. The "Correlation" study compared the device's results to another device, essentially evaluating its standalone accuracy.

7. The Type of Ground Truth Used

• For the correlation study, the ground truth was established by the results obtained from a similar, presumably already validated, device.
• For sensitivity, the ground truth was based on known concentrations of hCG (25 mIU/mL or greater).
• For specificity, the ground truth was based on known concentrations of other hormones (LH, FSH, TSH) in both negative and positive hCG specimens.
• For precision/tolerance, the ground truth involved coded specimens with known (negative, low positive, high positive) hCG status to assess consistency.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device development or machine learning. For traditional immunoassay devices, there isn't a separate training set in the same way there would be for an AI/ML algorithm. The development of the device's reagents and design would implicitly use various samples during the R&D phase, but these are not typically referred to as a "training set" in regulatory submissions for these types of devices.

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

As no "training set" is explicitly mentioned for this type of immunoassay device, the method for establishing its ground truth is not applicable. The device's performance relies on the biochemical specificity of its antibodies and the design of the assay, rather than learned patterns from a training dataset.

Ask a specific question about this device