(65 days)
One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Urine RCG (Cassette Format) One Step Test Kit
While the provided documents confirm FDA clearance for the Urine HCG (Cassette Format) One Step Test Kit and describe its intended use, they do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the documents are a 510(k) clearance letter and an Indications for Use statement. These documents confirm substantial equivalence to a predicate device and outline the intended use, but they do not present the technical performance data, study design, or specific acceptance criteria in the way a scientific study report would.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details based solely on the provided text.
However, based on what is typically expected for an in vitro diagnostic device like a pregnancy test and what might be inferred from such a regulatory submission, here's a general idea of what that information would look like if it were present:
Hypothetical Acceptance Criteria and Study Information (Based on typical IVDD requirements, NOT the provided document)
Since the provided document is an FDA clearance letter and an "Indications For Use" statement, it does not contain the detailed technical performance study information you are asking for. However, for a device like a pregnancy test, the following information would typically be part of the submission that led to this clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Sensitivity (Detection of hCG at 25 mIU/mL) | ≥ 99% | 99.5% |
| Specificity (Absence of hCG in negative samples) | ≥ 99% | 100% |
| Accuracy (Overall agreement with reference method) | ≥ 99% | 99.8% |
| Cross-Reactivity (Interference from related hormones) | ≤ 1% positive bias (LH, FSH, TSH) | No significant cross-reactivity observed |
| Hook Effect (High-dose insensitivity) | No hook effect up to 500,000 mIU/mL hCG | No hook effect up to 500,000 mIU/mL hCG |
| Expected Values (Correct identification of pregnant/non-pregnant samples) | Clinically acceptable range | Consistent with expected clinical outcomes |
| Precision (Reproducibility between runs/lots) | CV ≤ 10% | CV |
§ 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.