(92 days)
The Instant-View TM Pregnancy Combo 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 a breakdown of the acceptance criteria and the study details for the Instant-View™ Pregnancy Combo Test, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like minimum sensitivity or specificity targets). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The primary acceptance criterion appears to be achieving 100% agreement with the predicate device in terms of results.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to legally marketed devices via 100% correlation of results | Accuracy: 100% correlation with QuikpacII-One Step HCG Combo Test (predicate device). |
| Agreement with expected results: 100% agreement in clinical lab and physician's offices studies. | |
| Intended use: Early detection of hCG in human urine and serum at levels close to or greater than 25 mIU/ml (calibrated against WHO 3rd IS 75/537) | Performance meets this intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "The evaluation results from clinical lab and three physician's offices." It does not provide the specific sample size for the test set (number of urine/serum samples or individual subjects).
- Data Provenance: The study was conducted in a "clinical lab and three physician's offices." It doesn't specify a country of origin but implies a US context given the FDA submission. The context of a 510(k) submission generally implies prospective studies for the device seeking approval, but the exact nature (retrospective/prospective) of the sample collection for this specific study is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states, "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."
- Number of Experts: Not explicitly stated. It refers to "persons" at the clinical lab and physician's offices, implying multiple individuals.
- Qualifications of Experts: Described as "persons with diverse educational backgrounds and working experience." Specific professional qualifications (e.g., radiologist, medical technologist) and years of experience are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that the "results agreed 100% with the results expected," suggesting direct comparison to a known or established 'true' result for each sample, rather than a concensus process among multiple readers for the test device itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly done. The study's focus was on demonstrating substantial equivalence to a predicate device by comparing the new device's results to the predicate's results and "expected results." There is no mention of human readers improving with or without AI assistance, as this is a qualitative immunoassay device, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The entire evaluation described is of the "Instant-View™ Pregnancy Combo Test" itself. Its performance was assessed independently by comparing its results to a predicate device and "expected results" in a clinical setting.
- Accuracy: It showed 100% correlation with the predicate device (QuikpacII-One Step HCG Combo Test) and 100% agreement with expected results.
7. Type of Ground Truth Used
The ground truth appears to be established through two primary methods:
- Predicate Device Comparison: The results of the Instant-View™ Pregnancy Combo Test were compared 100% to those of the "QuikpacII-One Step HCG Combo Test" (the predicate device, K945951), which is assumed to provide the ground truth for comparison.
- "Expected Results": The evaluation also agreed 100% with "results expected." This implies that for some samples, the true hCG status (positive/negative) was known beforehand, possibly through reference methods or clinical diagnosis, serving as a form of ground truth.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is a qualitative immunoassay, not an AI/machine learning device that typically requires a distinct training set. The descriptions relate to the evaluation of the final product.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the establishment of ground truth for such a set is not applicable or described in this document.
§ 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.