(294 days)
The FIRST RESPONSE " Gold Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
The FIRST RESPONSE™ Gold™ Digital Pregnancy Test is a test system for the detection of human chorionic gonadotropin (hCG) hormone. Specifically, it is a screening device intended for the early detection of pregnancy by the lay user through the qualitative detection of hCG in urine as early as six (6) days before the day of the missed period. The detection of hCG in the urine of a pregnant woman is accomplished by a series of immunochemical reactions via component reagents that are deposited onto a chromatographic strip contained within a plastic housing. A digital component integral with the chromatographic strip reads and displays the result of the immunochemical reaction on an LCD (Liquid Crystal Display) screen of the device in place of the colored lines of the predicate device. Following the instructions for use provided with the device, the test is performed by placing the absorbent collection tip of the device into the urine stream for 5 seconds (or alternatively by fully immersing the collection tip for 5 seconds in a urine sample that was collected in a cup). A clock symbol will begin to blink in about 30 seconds after the urine is applied to indicate to the consumer that the test is working. The test result is read on the LCD screen of the device within 3 minutes. A "YES+" test result indicates that the pregnancy hormone (hCG) was detected (pregnant) and a "NO-" test result indicates that no hCG was detected (not pregnant).
This document describes the 510(k) summary for the FIRST RESPONSE™ Gold™ Digital Pregnancy Test. While it thoroughly outlines various studies conducted to demonstrate substantial equivalence, it does not present a formal table of "acceptance criteria" with explicit quantitative targets that the device was required to meet for each performance metric. Instead, the document describes a series of studies designed to show performance comparable to the predicate device or to establish key analytical characteristics.
Therefore, the response below will interpret "acceptance criteria" based on the nature of the studies performed and the conclusions drawn in the document, acknowledging that explicit numerical acceptance targets are not formally presented in a table format in the provided text. The "reported device performance" will be derived from the specific findings mentioned for each study.
Device: FIRST RESPONSE™ Gold™ Digital Pregnancy Test
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria with specific numerical targets are not formally presented in a table in the provided document, the "acceptance criteria" are inferred from the stated purpose of each study and the conclusion of substantial equivalence. "Reported device performance" is derived from the study outcomes described.
| Performance Metric (Inferred Acceptance Criterion) | Reported Device Performance |
|---|---|
| Accuracy (vs. Predicate Device): Demonstrate no discrepancies in accuracy compared to the predicate device using quantified hCG urine samples. | Status: Met. "The study showed no discrepancies in accuracy." |
| Analytical Sensitivity: Achieve a specified analytical sensitivity (e.g., 10 mIU/mL). | Status: Met. "The data demonstrate that the analytical sensitivity is 10 mIU/mL with a 50/50 cutoff of 6 mIU/mL for both midstream and dip method." |
| Lay User Performance: Demonstrate no difference in device performance between lay users and laboratory professionals. | Status: Met. "The data demonstrate no difference in device performance between lay users and laboratory professionals." |
| Intra and Inter-lot Precision: Demonstrate no significant intra or inter lot-to-lot variability using hCG standards. | Status: Met. "The data demonstrate no intra nor inter lot-to-lot variability." |
| Interfering Substances & Homologous Hormones: Demonstrate no effect on performance when challenged with potential interfering substances and homologous hormones. | Status: Met. "The data demonstrate no effect on the performance of the device." |
| High Dose Hook Effect: Demonstrate no high dose hook effect when challenged with very high levels of intact hCG. | Status: Met. "The data demonstrate no effect on the performance of the device." |
| hCG Beta Core Fragment (hCG ßcf): Confirm no detrimental effect on performance from high levels of hCG ßcf. | Status: Met. "The results of this study show no detrimental effect on the performance of the device." |
| Early Pregnancy Detection: Demonstrate ability to detect hCG days before the missed period (specifically 6 days). | Status: Met. "The data demonstrate that the device can detect hCG 6 days before the missed period." The intended use also states detection as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. |
| False Positive Rate (Pre/Peri/Post-menopausal Women): Demonstrate zero potential for false positive results in pre-, peri-, and post-menopausal women. | Status: Met. "The data demonstrate that the potential for false positive results in the subpopulations is zero." |
| Consumer Self-Use & Interpretation: Demonstrate that consumers can perform the test and interpret the results correctly. | Status: Met. "The data demonstrate that consumers can perform the test and interpret the result correctly." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document details multiple laboratory and consumer studies but does not specify the exact sample sizes (number of individuals or urine samples) used for each test set. It mentions the use of "urine samples quantified for hCG levels from pregnant and non-pregnant women" and "hCG standards of known concentration" for laboratory studies, and "lay users" for consumer studies.
- Provenance: The document does not explicitly state the country of origin for the data. Given it's an FDA 510(k) submission, it's typically assumed to be U.S.-centric or globally sourced data acceptable to FDA. The studies appear to be prospective in nature, involving testing new samples with the device, especially the consumer studies and early pregnancy detection study (using conceptive cycles).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document mentions "laboratory professionals" for comparison with lay users and the use of "urine samples quantified for hCG levels." This implies an existing, validated reference method for hCG quantification (e.g., a laboratory immunoassay) was used to establish the ground truth for hCG levels.
- Number of Experts: Not specified.
- Qualifications of Experts: Implied medical/laboratory professionals capable of performing quantitative hCG assays and clinical interpretation. (e.g., Clinical Laboratory Scientists, Medical Technologists). No specific board certifications or years of experience are listed.
4. Adjudication Method for the Test Set
The document does not describe a formal multi-reader or adjudication process (e.g., 2+1, 3+1) for establishing ground truth, as it's a diagnostic test for a chemical analyte (hCG). Ground truth for hCG levels would typically be established by a quantitative reference assay, not by expert consensus reading of images or similar subjective interpretations. For the consumer studies, the ground truth was likely the quantitative hCG level of the sample and/or the result from the laboratory professional.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. This device is a standalone in-vitro diagnostic (IVD) pregnancy test, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies. The "digital component" is described as reading and displaying the result of the immunochemical reaction, replacing subjective reading of lines with a clear "YES+" or "NO-".
- Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable and not reported. The "digital component" serves as an automated reader for the immunoassay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a form of standalone performance was implicitly done. The device's "digital component integral with the chromatographic strip reads and displays the result... an optimized algorithm capable of determining and correctly interpreting the assay result and displaying a simple "YES+" or "NO-"." The laboratory studies evaluating analytical sensitivity, accuracy against quantified samples, precision, and interference are essentially evaluating the "algorithm only" performance of the digital system in interpreting the immunoassay reaction.
- The "consumer self-use study" confirms the user's ability to perform the test and interpret the digital result, but the core "reading" is done by the device's internal algorithm.
7. Type of Ground Truth Used
- The primary ground truth used for the analytical and clinical performance studies was quantitative human chorionic gonadotropin (hCG) levels in urine samples. These levels were "quantified for hCG" using a reference method.
- For the early pregnancy detection study, the ground truth was tied to the woman's conceptive cycle and the number of days before the missed period, correlating with the presence and quantifiable levels of hCG at those specific time points.
- For the consumer studies, the ground truth was likely the known hCG status of the urine sample (pregnant/non-pregnant based on quantitative levels) and the interpretation provided by the "laboratory professionals" for comparison.
8. Sample Size for the Training Set
- The document does not specify a separate training set size. The description focuses on verification and validation studies to demonstrate substantial equivalence. For IVDs, "training" might refer to the development and optimization of the internal algorithm/optical components during the design phase. The data used for the performance studies described are typically considered the 'test set' for validation to support market clearance.
9. How the Ground Truth for the Training Set Was Established
- Since a distinct "training set" isn't explicitly described or quantified, the method for establishing its ground truth is not detailed. However, if one assumes an internal optimization/development phase for the "optimized algorithm," the ground truth would similarly have been established using quantified hCG urine samples and possibly other defined standards to teach the algorithm to accurately interpret the immunochemical reaction and display the correct "YES+" or "NO-" result. This process would occur prior to the formal validation studies.
§ 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.