(92 days)
The Instant-View TM Pregnancy Combo Dip-Strip Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in human urine and serum. The test is for use as an aid in the diagnosis of early pregnancy.
The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy.
This test is for laboratory and professional use only.
A single step, visually read, qualitative chromatographic immunoassay, single use cassette test
Here's an analysis of the provided text regarding the acceptance criteria and study for the Instant-View™ Pregnancy Combo Dip-Strip Test, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device characteristics) | Reported Device Performance (Instant-View™ Test) |
|---|---|
| Qualitative detection of hCG in human urine and serum. | Yes (stated intended use). |
| Detection level close to or greater than 25 mIU/ml hCG (calibrated against WHO 3rd IS 75/537). | Yes (stated performance characteristic). |
| Accuracy (correlation with predicate device) | 100% agreement. |
| Agreement with expected results (from clinical lab and physician's offices) | 100% agreement. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify:
- The exact sample size (number of urine/serum samples) used for the test set.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
It only mentions "results from clinical lab and three physician's offices," suggesting clinical testing was performed, but without quantitative details on the number of patients or samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "The evaluation results from clinical lab and three physician's offices conducted by the persons with diverse educational backgrounds and working experience agreed 100% with the results expected."
This phrasing is vague. It indicates that multiple individuals (likely staff at the clinical lab and the physician's offices) interpreted the results. However, it does not specify:
- The exact number of "experts" (e.g., how many individuals in the clinical lab, how many physicians).
- Their specific qualifications (e.g., "radiologist with 10 years of experience" - this level of detail is absent).
- Who established the "results expected" (ground truth). It implies a reference method was used, but details are missing.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (such as 2+1 or 3+1). It simply states that the "persons with diverse educational backgrounds and working experience agreed 100% with the results expected." This implies either perfect agreement or that the "ground truth" was directly compared without a separate adjudication process for reader discrepancies.
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 conducted. The study primarily focused on demonstrating substantial equivalence to a predicate device and direct agreement with expected results, not on comparing human reader performance with and without AI assistance (as this is a qualitative immunoassay, not an AI-driven image analysis tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The Instant-View™ Pregnancy Combo Dip-Strip Test is itself a standalone diagnostic device. Its performance is evaluated based on its ability to produce a visual result (presence or absence of a T line) when presented with a sample. The "evaluation results" refer to the interpretation of this visual result by various personnel. There's no separate "algorithm" in the modern AI sense, but the device itself is a self-contained test system. The reported accuracy of 100% against the predicate and 100% agreement with expected results can be considered its standalone performance.
7. The Type of Ground Truth Used
The ground truth was established by:
- Correlation with a legally marketed predicate device: The results were compared to the "QuikpacII-One Step HCG Combo Test made by Syntron Bioresearch, Inc." The document states a 100% correlation.
- "Results expected": The outcome of the test (positive or negative) was compared against "results expected," which would logically be derived from a reference method or established clinical pregnancy status for the samples used. The document does not explicitly state the specific "reference standard" for these "expected results" beyond the predicate device comparison.
8. The Sample Size for the Training Set
The document does not mention a "training set." This type of immunoassay device does not typically involve machine learning or AI models that require distinct training sets in the computational sense. The "training" for such devices would be the manufacturing and quality control processes to ensure consistent performance, not a data-driven model training process.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of data for an algorithm, there is no information on how its ground truth was established.
§ 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.