(50 days)
The INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.
The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.
The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.
INNOVITA HCG Pregnancy Rapid Test will be sold in three different formats: cassette, test strip. 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. INNOVITA HCG Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the detection of pregnancy. The test device contains mouse monoclonal anti-chCG antibody coated membrane and a pad containing mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
Here's a breakdown of the acceptance criteria and study details for the INNOVITA HCG Pregnancy Rapid Test, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytical Sensitivity (Detection Limit) | $25 \text{mIU/mL}$ |
| Cross-Reactivity (No interference from related hormones) | No cross-reactivity at $500 \text{mIU/mL LH}$, $1000 \text{mIU/mL FSH}$, or $1000 \text{μIU/mL TSH}$ |
| Interference from Endogenous/Exogenous Compounds | No interference observed at tested high concentrations for a list of common interferents (e.g., acetaminophen, albumin, glucose, hemoglobin) |
| Effect of Urine pH | Test results not affected by urine pH across $4.0 \text{ to } 9.0$ |
| Effect of Urine Specific Gravity | Test results not affected by urine specific gravity between $1.003 \text{ and } 1.030$ |
| Interference from hCG β-core Fragment | No interference observed for hCG-β core fragment concentrations up to $1 \text{μmol/L}$ |
| High Dose Hook Effect | No hook effect observed for hCG concentrations up to $2000 \text{IU/mL}$ |
| Method Comparison Agreement with Predicate Device | $100%$ agreement between INNOVITA HCG Pregnancy Rapid Test and the predicate device (across all formats) |
| Lay User Study (Ease of Use, Understanding, Interpretation) | Most participants found the device easy to use, instructions easy to understand, and results easy to interpret. Package insert reading level verified as 7th grade (Flesch-Kincaid). |
| Shelf-Life (Stability) | $3 \text{ years}$ when stored at $4^\circ\text{C}-30^\circ\text{C}$ in a sealed foil pouch |
Study Details
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Sample size used for the test set and the data provenance:
- Analytical Sensitivity: 30 replicates for each of 7 hCG concentrations ($0, 12.5, 18.75, 25, 37.5, 50, 100 \text{mIU/mL}$) per lot, across 3 lots and 3 device formats. This equates to $30 \times 7 \times 3 \times 3 = 1890$ individual tests. Data provenance is not explicitly stated but implies laboratory testing with spiked urine samples.
- Cross-Reactivity: 5 devices from each format * (number of hormone concentrations) * (number of hCG presence levels). For example, for LH, it's $5 \times 3 \times 3 = 45$ tests for each format. Total tests for cross-reactivity with LH, FSH, and TSH: $45 \times 3 \times 3 + 45 \times 3 = 405 + 135 = 540$ (approximately) across all formats. Urine samples were spiked.
- Endogenous/Exogenous Compounds: 5 devices from each format * (number of interferents) * (at least 2 levels). Urine samples were spiked. The exact total number of tests isn't calculated but would be substantial.
- Urine pH: 5 devices from each format * (number of pH levels: 6) * (2 hCG levels: negative and $25 \text{mIU/mL}$). Total tests were $5 \times 6 \times 2 \times 3 = 180$ across all formats. Urine samples were adjusted for pH.
- Urine Specific Gravity: 5 devices from each format * (number of SG ranges: 3) * (2 hCG levels: negative and $25 \text{mIU/mL}$). Total tests were $5 \times 3 \times 2 \times 3 = 90$ across all formats. Urine samples with different specific gravities were collected and spiked.
- hCG β-core Fragment: 3 devices from each format * (number of fragment concentrations: 2) * (2 hCG levels: negative and $25 \text{mIU/mL}$). Total tests were $3 \times 2 \times 2 \times 3 = 36$ across all formats. Urine samples were spiked.
- High Dose Hook Effect: 3 devices from each format * (number of hCG concentrations: 9). Total tests were $3 \times 9 \times 3 = 81$ across all formats. Urine samples were spiked.
- Method Comparison with Predicate: 300 fresh urine samples from females aged 18-49. Prospective collection, but the country of origin is not specified.
- Lay User Study: An unspecified number of females with diverse ethnic and educational backgrounds, aged 18-49. Prospective collection, but the country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Method Comparison Study, 5 Healthcare Professionals (HCPs) were involved in reading the tests. Their specific qualifications (e.g., years of experience, specialty) are not detailed.
- For the Lay User Study, the "Healthcare Professional" performed the comparison test; their qualifications are not detailed beyond "Healthcare Professional."
- For analytical studies (sensitivity, cross-reactivity, interference, etc.), ground truth was established by precise laboratory spiking of hCG or interferents, implying expert laboratory technicians were involved in preparing and verifying the concentrations.
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Adjudication method for the test set:
- For the Method Comparison Study and Lay User Study, the document mentions that a Healthcare Professional performed one test. It does not explicitly mention an adjudication method (like 2+1 or 3+1 for conflicting interpretations). For the lay user study, the comparison was between the lay user's result and the HCP's result, implying the HCP's result served as the reference for accuracy.
- For analytical studies, results are based on observation of positive/negative lines based on known spiked concentrations, thus reducing the need for adjudication in the traditional sense.
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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 as this device is a manual, visual rapid test, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic device in the sense that its performance does not rely on a human reader's interpretation in the scientific validation, but rather on the objective appearance of a line. The "algorithm" is the biochemical reaction and visual detection. The performance data is the standalone performance of the device without human interpretation variability, aside from the lay user study where interpretation is tested as part of user-friendliness.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical studies (sensitivity, cross-reactivity, interference, etc.), the ground truth was based on known, precisely spiked concentrations of hCG and other substances in urine samples. This is a highly controlled laboratory ground truth.
- For the Method Comparison Study, the ground truth was established by the predicate device's result and the Healthcare Professional's concurrent reading of the new device.
- For the Lay User Study, the ground truth for comparison was the Healthcare Professional's reading of the same urine sample using the same device format.
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The sample size for the training set:
- This document describes performance studies for a finished medical device (test strips), not a machine learning model. Therefore, there is no concept of a training set in the context of AI. The "training" of the device is its manufacturing process to ensure consistent biochemical reactivity.
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How the ground truth for the training set was established:
- As there is no training set for an AI model, this question is not applicable.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.