(254 days)
DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test 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.
This product is intended for over-the-counter use.
DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test 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.
This product is intended for over-the-counter use.
DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test 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. This product is intended for over-the-counter use only.
DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test 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.
This product is intended for prescription use.
DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test 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. This product is intended for prescription use.
DAVID One Step Pregnancy Test is designed in three formats: strip, cassette, and midstream. Each of the devices (strip, cassette and midstream) contains a pouch with the test device and instructions for use, additional test cassette also contains a disposable plastic dropper. The test cassette and test midstream consist of a chromatographic test strip enclosed in plastic housing. The test strip contains mouse monoclonal anti-ß-hCG antibody, mouse monoclonal anti-a-hCG antibody, goat anti-mouse IgG polyclonal antibody and colloidal gold.
The added plastic housing does not affect the performance of the product, which is determined by the test strip. The only difference between the different formats is test procedure.
The test uses two lines to indicate results. The appearance of two color bands, one at the "Test line" and one at the "Control line" region means the test is "positive". The appearance of a color band at the "Control line" region but not at the "Test line" region means the test is "negative". If there are no colored bands in the "Control line" area and "Test line" region or if there is no color band in "Control line" region even there is a band in the "Test line" region; this means "invalid" test result.
Here's a breakdown of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a formal table with pass/fail metrics. However, based on the performance data presented, the implicit acceptance criteria for a qualitative pregnancy test device would be high accuracy, analytical sensitivity, and no significant interference. The reported performance is summarized below:
| Criteria/Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (Lowest concentration for 100% positive) | Achieve 100% positive results at 10 mIU/mL and 50% positive at 7.5 mIU/mL. | Strips, Cassettes, Midstreams (all methods): 100% positive at 10 mIU/mL, ~48-50% positive at 7.5 mIU/mL (across 3 lots and different operators/methods). |
| Specificity (Cross-reactivity) | No cross-reactivity with LH (500mIU/mL), FSH (1000mIU/mL), and TSH (1000μIU/mL). | No cross-reaction observed with LH at 500mIU/mL, FSH at 1000mIU/mL, and TSH at 1000μIU/mL. |
| Specificity (Interference from common substances) | No interference from specified endogenous and exogenous compounds at relevant concentrations. | No interference observed from various compounds including Glucose, Albumin, Hemoglobin, Bilirubin, Estriol, common birth control pills, progestational drugs, prescription/OTC substances (Acetaminophen, Aspirin, Caffeine, etc.), antibiotics (Amikacin, Penicillin G, etc.) at specified concentrations. |
| Specificity (pH Effects) | No interference across a physiological urine pH range. | No interference observed with urine pH ranging from 4 to 9. |
| Specificity (Specific Gravity Effects) | No interference across a physiological urine specific gravity range. | No interference observed with urine specific gravity ranging from 1.000 to 1.050. |
| High Dose Hook Effect | No hook effect up to a very high hCG concentration. | No hook effect observed up to 2,000,000 mIU/mL hCG. |
| Interference from hCG ß-core Fragment | Limited or no interference from hCG ß-core fragment. | Interference demonstrated at concentrations of 1,000,000 pmol/L. |
| Method Comparison with Predicate Device | High agreement with the predicate device. | 100% agreement (Positive: 52-73, Negative: 47-68) with the predicate device for all formats. |
| Clinical Sensitivity in Early Pregnancy | High detection rate on or after the expected period, and acceptable detection rate in early days before the expected period. | Strips: 100% from EMP to EMP+2, declining to 0% at EMP-10. Cassettes: 100% from EMP-2 to EMP+2, declining to 0% at EMP-10. Midstreams (dip): 100% from EMP-1 to EMP+2, declining to 0% at EMP-10. Midstreams (simulated stream): 100% from EMP-3 to EMP+2, declining to 1% at EMP-10. |
| Lay User Study (Accuracy) | High agreement between lay users and professionals. | 100% agreement between lay users and professionals for all formats (50 positive, 70 negative cases). For spiked samples, 100% positive at 10mIU/mL and 11.5mIU/mL, 1-2% positive at 5mIU/mL, and 43-46% positive at 8mIU/mL. |
| Lay User Study (Usability) | Easy to use, understandable labeling, correct interpretation of results by lay users. | Questionnaire results reflect that consumers found the device easy to use and had no trouble understanding labeling or interpreting results. Flesch-Kincaid reading analysis indicated an 8th-grade reading level for instructions. |
| Non-pregnant Urine Sample Analysis | Low to zero false positive rate in non-pregnant individuals. | 0% false positive in pre-menopausal and menopausal groups, 1 false positive out of 300 (0.33%) in the post-menopausal group (>55 years old) due to naturally higher hCG levels. |
2. Sample Size Used for the Test Set and Data Provenance
- Analytical Performance (Precision/Reproducibility): For each hCG concentration, 50 samples were tested per lot, across 3 lots, for each of 3 formats (strips, cassettes, midstreams). This totals 450 samples per hCG concentration for each format (50 samples/lot * 3 lots * 3 sites * 1 investigator/site * 5 days = not explicitly detailed, but 50/50 for each lot implies 50 samples). This was conducted at 3 sites.
- Analytical Performance (Detection Limit): 30 samples for each concentration, for 10 concentrations, per lot, across 3 lots, for each of 3 formats via 4 test methods (strip, cassette, midstream dip, midstream stream). (30 samples/concentration * 3 lots * 4 test methods = 360 samples per concentration level). Urine samples were from healthy non-pregnant women.
- Provenance: Data appears to be prospective as samples were spiked and tested. The country of origin for the samples is not explicitly mentioned but the applicant is from China, so it's likely China.
- Method Comparison with Predicate Device: 120 urine samples tested simultaneously with the predicate device and the proposed devices.
- Provenance: Not specified if retrospective or prospective, but likely prospective for comparison.
- Detection of hCG in Early Pregnancy Clinical Samples: 1287 urine samples collected from 99 different women (20-40 years old).
- Provenance: Prospective collection from women followed throughout their conception cycles. Specific country of origin is not mentioned, but given the applicant, likely China.
- Lay User Study:
- First study (professional vs. non-professional comparison): 120 volunteers per site (50 pregnant, 70 non-pregnant) across 3 sites (one format per site). This totals 360 volunteers.
- Second study (spiked samples with lay users): 120 volunteers per site, detecting 4 spiked samples, across 3 sites.
- Provenance: Prospective, conducted on Chinese mainland with women volunteers (20-40 years old).
- Non-pregnant Urine Sample Analysis: 900 samples tested across three clinical trial sites, with 100 samples from each of three age groups (pre-menopausal, menopausal, post-menopausal) per site, per format (not explicitly stated if per format, but described as "one format of device from 3 lots").
- Provenance: Not specified if retrospective or prospective. Likely collected specifically for the study.
3. Number of Experts and Qualifications for Ground Truth
- Clinical Samples (Early Pregnancy): "laboratory technicians (one for strip, one for cassette format, and one for midstream for both dip and stream methods)" performed the initial testing. The ultimate ground truth for positive samples was confirmed with "ultrasound scan." No specific number or qualifications for the laboratory technicians or sonographers are provided beyond "laboratory technicians."
- Lay User Study: "professionals" tested the simultaneously collected urine samples, and their results were used as ground truth for comparison with lay users. No specific number or qualifications of these "professionals" are detailed.
- Non-pregnant Urine Sample Analysis: "professionals" tested the samples. For the false positive in the post-menopausal group, the concentrations of these samples "were determined to be higher than the cut-off of the device by quantitative test," implying a quantitative lab test was the ground truth for that specific follow-up.
4. Adjudication Method for the Test Set
- Analytical Performance (Precision/Reproducibility & Detection Limit): "1 investigator" per site for precision tests, and "12 laboratory operators" divided into 4 groups for detection limit tests. There is no explicit mention of an adjudication method among multiple readers for these analytical studies. Results are aggregated.
- Clinical Samples (Early Pregnancy): One laboratory technician per format/method combination performed the initial testing. The ultimate confirmation for positive results was "ultrasound scan." There is no mention of explicit adjudication among multiple human readers for initial interpretations.
- Lay User Study: Professionals served as the ground truth for comparison with lay users. There is no mention of an adjudication method among these professionals if multiple were involved in reading the "ground truth" results for each sample. For the lay user study where spiked samples were tested by lay users, the ground truth was the known concentration of hCG in the spiked samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No formal MRMC comparative effectiveness study was done to compare human readers with and without AI assistance. This device is a rapid diagnostic test (lateral flow immunoassay) that provides a visual qualitative result (lines present or absent) directly to the user or a healthcare professional, not an AI-powered image analysis system. Therefore, the concept of "AI assistance" in the context of improving human reader performance is not applicable here.
6. Standalone Performance
Yes, a standalone performance was done. The entire analytical and clinical performance sections detail the algorithm's (device's) performance without human-in-the-loop directly influencing the result generation. For instance, the analytical sensitivity, specificity, and comparison with a predicate device are all examples of the device's standalone performance. The "lay user study" and "non-pregnant urine sample analysis" also contribute to understanding the device's performance when interpreted by humans (lay users or professionals).
7. Type of Ground Truth Used
- Analytical Performance:
- Precision/Reproducibility & Detection Limit: Known concentrations of spiked HCG standard in negative urine samples.
- Cross-reactivity & Interference: Known concentrations of interfering substances spiked into negative and positive (10 mIU/mL hCG) urine samples.
- pH & Specific Gravity: Known pH and specific gravity values of urine samples.
- High Dose Hook Effect: Known high concentrations of hCG.
- Clinical Samples (Early Pregnancy): "Ultrasound scan" confirmed positive pregnancy. For non-pregnant cases, it implies absence of ultrasound-confirmed pregnancy.
- Lay User Study:
- Professional Comparison: Results from testing by "professionals" using the same urine samples as lay users.
- Spiked Samples: Known concentrations of hCG in the spiked urine samples.
- Non-pregnant Urine Sample Analysis: Absence of pregnancy (based on age group and general health status) and, for the false positive case, validation by "quantitative test" for hCG concentration.
8. Sample Size for the Training Set
The provided document describes premarket testing and clinical studies to evaluate the device. It does not mention a training set or a machine learning (AI) algorithm that would typically require such a set. This is a traditional in-vitro diagnostic device.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, this question is not applicable.
§ 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.