(32 days)
The FIRST RESPONSE® 1-Step Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to four (4) days prior to the expected menses
The device detects the presence of hCG in the urine of a pregnant woman by a series of immunochemical reactions via component reagents striped onto a chromatographic strip contained within plastic housing.
Here's a breakdown of the acceptance criteria and study information for the FIRST RESPONSE® Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in the typical format of a performance study (e.g., "sensitivity must be > X%"). Instead, the acceptance criterion for this 510(k) essentially revolved around demonstrating that the device could reliably detect hCG earlier than its predicate while maintaining comparable performance.
The reported device performance is described in terms of its ability to detect hCG at various days before the expected period. While specific percentages are mentioned, they are presented as a revision/reinterpretation of existing data rather than new study outcomes against defined criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to detect hCG as early as four (4) days before the expected menses. | The device demonstrated the ability to detect hCG 4 days, 2 days, and 1 day before the expected period. (Specific percentages are not provided in this summary but are referenced as revised labeling based on reinterpreted data from K992232). |
| Performance comparable to predicate devices (FIRST RESPONSE® Pregnancy Test - K992232 and Clearblue Easy® Early Result - K013372). | The subject device and the predicate version of FIRST RESPONSE® are identical except for the number of early detection days. It is stated to be "very similar" to Clearblue Easy®, with "similar performance (per analytical and consumer study data previously provided)" in K992232. The reinterpreted data for the current submission also includes percentages for 3 days before and 2 days before the expected period (which differ due to a change in the basis of calculation, not underlying data changes). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state a sample size for a new test set in this 510(k) submission. It mentions that the sponsor "reinterpreted the same data provided in K992232." Therefore, the test set data originates from the studies performed for the predicate device, K992232.
- Data Provenance: The data is retrospective as it was previously acquired for K992232 and re-analyzed for the current submission. The country of origin is not specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. Given the nature of a pregnancy test (detecting hCG in urine), ground truth would typically be established by confirmed pregnancy outcomes or quantitative laboratory hCG levels, rather than interpretation by clinical experts in the traditional sense.
4. Adjudication Method for the Test Set:
- The document does not specify an adjudication method. For a qualitative pregnancy test, ground truth is usually established by objective criteria (e.g., quantitative hCG levels, subsequent pregnancy confirmation), rather than subjective expert adjudication of the test result itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as described in this document. The device is an in vitro diagnostic test, not an imaging or interpretive device that typically involves human readers in the same way clinical algorithms do. The "consumer study data" mentioned from the predicate (K992232) might refer to usability or non-expert interpretation, but not a formal MRMC study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Yes, this submission describes standalone performance. The device itself is a standalone, over-the-counter diagnostic test that provides a result without requiring human interpretation beyond reading the result line(s). The performance data cited relates directly to the device's ability to detect hCG. There is no "human-in-the-loop" aspect to its primary function of detection.
7. Type of Ground Truth Used:
- The ground truth used was based on quantitative hCG levels and likely confirmed pregnancy outcomes (as implied by "percentage of women in which the device detected the hormone X days before... expected period" and "conceptive cycles"). The predicate test's claims were based on "the percentage of cycles having quantitative hCG levels approximating the claimed sensitivity level or greater."
8. Sample Size for the Training Set:
- The document does not provide a specific sample size for a training set. Since this submission reinterpreted data from a prior 510(k) (K992232), any "training" or development data would have originated from that earlier submission, and its details are not present here.
9. How the Ground Truth for the Training Set Was Established:
- Similar to the test set, the ground truth for any underlying development/training from the K992232 submission would have been established by quantitative hCG levels and/or confirmed pregnancy outcomes. The text specifically mentions "hCG levels approximating the claimed sensitivity level or greater."
§ 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.