Search Results

Innovacon™ hCG Ultra Test Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. It is for healthcare professionals only.

The test utilizes a combination of antibodies including mouse monoclonal antihCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding urine or serum specimens to the specimen well of the test 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 colored antibody conjugates and 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.

The Innovacon™ hCG Ultra Test Device is a rapid test that qualitatively detects hCG at the sensitivity of 10 mIU/mL in serum and 20 mIU/mL in urine. The cutoff concentration of this test has been standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589). At the level of claimed sensitivity, the hCG Ultra Test Device shows no cross-reactivity interference from the structurally related glycoprotein hormones FSH, LH and TSH at extra high physiological levels.

The provided text describes the Innovacon™ hCG Ultra Test Device, a pregnancy test kit for professional use, and its 510(k) clearance (K062361). The clearance document confirms the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" as a formal table with quantitative targets. Instead, it describes performance characteristics and claims substantial equivalence to a predicate device. The primary "acceptance criteria" appear to be:

• Qualitative detection of hCG in serum or urine.
• Sensitivity: 10 mIU/mL in serum and 20 mIU/mL in urine.
• No cross-reactivity with FSH, LH, and TSH at extra high physiological levels.
• Robustness and accurate results under adverse conditions (referring to various laboratory studies).
• Ease of use, clear labeling, and interpretable results.

Here's a table summarizing the performance claims:

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

The text refers to a "clinical study" and "POL study" (presumably referring to Point-of-Care/Limited laboratory settings), but does not specify the sample size for these studies.

• Data Provenance: The clinical study was "conducted in three sites in the U.S." This indicates the data is from the United States and appears to be prospective, as it was conducted specifically to evaluate the new device.

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

The document does not specify the number of experts used or how ground truth was established for the clinical study. It mentions the study was conducted by "healthcare professionals with varying educational backgrounds and laboratory experience." This suggests general healthcare professionals were involved but doesn't detail their qualifications for establishing a definitive ground truth for hCG levels.

4. Adjudication Method for the Test Set

The text does not describe any adjudication method (e.g., 2+1, 3+1, none) for reconciling discrepancies or establishing a definitive ground truth in the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document describes a "performance equivalency" study comparing the Innovacon device to the Fisher Sure-Vue Serum/Urine hCG-STAT test. It states this was done "by professionals," implying human readers were involved. However, it does not explicitly state that it was an MRMC study designed to measure the effect size of human readers improving with or without AI assistance. This is a rapid immunoassay, not an AI-powered diagnostic imaging device, so conventional MRMC studies measuring AI assistance are not applicable. The comparison here is between two different test kits as interpreted by human users.

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

This question is not applicable to this device. The Innovacon hCG Ultra Test Device is a rapid chromatographic immunoassay, which is a physical test kit requiring human interpretation of colored lines, not an algorithm or AI system. Its performance is inherently linked to human-in-the-loop steps (applying samples, reading results).

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated. Given that it's a pregnancy test, the ground truth would typically be established by:

• Laboratory reference methods: More sensitive and quantitative hCG assays (e.g., quantitative serum hCG).
• Clinical outcomes: Confirmation of pregnancy via ultrasound or other clinical signs.
• Predicate device results: In the context of a substantial equivalency claim, the results from the predicate device (Fisher Sure-Vue Serum/Urine hCG-STAT) would serve as a comparative ground truth.

The document states the device's cutoff concentration was "standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589)," indicating a scientific basis for the hCG levels.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is consistent with a traditional immunoassay device, which does not typically involve machine learning requiring training data. The "training" in this context would likely refer to the development and optimization of the assay components and parameters.

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

As there is no explicit mention of a training set in the AI/ML sense, this question is not applicable. The development of the assay's sensitivity and specificity would have been based on established medical and biological principles for detecting hCG, potentially using characterized hCG samples standardized to international references.

Ask a specific question about this device