(121 days)
MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment.
Only for use outside the body. For over the counter use.
MissLan™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.
The provided document details the performance characteristics of the MissLan™ Digital Pregnancy Rapid Test, which is a qualitative test for human chorionic gonadotropin (hCG) in urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list "acceptance criteria" for each performance metric with quantitative targets. Instead, it presents the results of various analytical and clinical studies, implying that the observed performance meets the requirements for demonstrating substantial equivalence to the predicate device.
However, we can infer the key performance metrics and the achieved results from the "Performance Characteristics" section. For qualitative pregnancy tests, crucial performance indicators include sensitivity (detection limit), specificity (absence of false positives), reproducibility, absence of hook effect, and agreement with predicate devices/professional results.
Inferred Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | Achieve 100% positive detection at the claimed sensitivity (25 mIU/mL hCG) and 100% negative detection at concentrations below the critical cutoff. Ensure consistent detection across multiple operators and lots. | - 25 mIU/mL hCG: 100% positive for both midstream and dip testing across all 3 operators and 3 lots (total 150 positive results for each method, 300 total). |
- 0 mIU/mL hCG: 100% negative for both midstream and dip testing across all 3 operators and 3 lots (total 150 negative for each method, 300 total).
- 12.5 mIU/mL hCG: 100% negative for both midstream and dip testing across all 3 operators and 3 lots (total 150 negative for each method, 300 total).
- Overall Sensitivity (for both methods combined): Demonstrated to be 25 mIU/mL.
- Reproducibility: Exhibited reproducible results across operators and lots. |
| Specificity | No false positive results should be observed from healthy non-pregnant individuals across various age groups. No significant cross-reactivity with structurally similar hormones (e.g., hLH, hFSH, hTSH) or hCG ß-core fragment. | - Non-pregnant healthy females: 300 urine samples from healthy, non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal groups (100 per group) showed no false positive results for both dip and midstream testing. - Cross-reactivity: No cross-reactivity was observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, or 1000 uIU/mL hTSH.
- hCG ß-core fragment: Performance not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L. |
| Hook Effect | No false negative results at very high concentrations of hCG. | No hook effect observed at hCG concentrations up to 500,000 mIU/mL (all tested concentrations from 6,250 mIU/mL to 500,000 mIU/mL gave a positive result). |
| Interference | Performance should not be affected by common interfering substances, urine pH, or urine density. | - Interfering substances: No interference effect observed for 25 listed substances (e.g., Glucose, Albumin, Hemoglobin, Acetaminophen, Aspirin, Ibuprofen, Ethanol, etc.) at specified concentrations. - Urine pH: Performance not affected by urine pH values between 4 and 9.
- Urine Density: Performance not affected by urine density values between 1.000 and 1.035. |
| Method Comparison | High conformity (ideally 100%) with a legally marketed predicate device. | - Midstream Method: 100% concordance (55 positive, 45 negative) with the predicate device (n=100). - Dip Method: 100% concordance (47 positive, 53 negative) with the predicate device (n=100).
- Overall Conformity: 100% between MissLan™ and the predicate device. |
| Lay Person Study | High agreement between lay user results and professional results. Easy to use and interpret. | - First Study (Self-Testing): 100% conformity (midstream: 55 positive, 45 negative; dip: 47 positive, 53 negative) between layperson results and professional results (for 200 women). - Second Study (Spiked Samples): 100% correct results for 5 mIU/mL (100 negative) and 25 mIU/mL (100 positive) hCG samples tested by laypersons.
- Questionnaire: Consumers found the test easy to use and had no trouble understanding labeling and interpreting results. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Analytical Performance (Sensitivity/Reproducibility):
- Sample Size: For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL):
- 10 replicates per day for 5 days = 50 replicates per operator per lot.
- 3 operators for each sample concentration.
- 3 device lots.
- Total tests per hCG concentration: 50 (replicates) * 3 (operators) * 3 (lots) = 450 tests.
- Total tests for all concentrations: 450 * 9 = 4050 tests across all concentrations, operators, and lots.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It implies a controlled laboratory setting (analytical performance).
- Sample Size: For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL):
-
Specificity (Non-pregnant females):
- Sample Size: 300 urine samples (100 from pre-menopausal, 100 peri-menopausal, 100 post-menopausal).
- Data Provenance: Not specified regarding country or retrospective/prospective.
-
Method Comparison Study:
- Sample Size: 200 urine samples from women presenting to test for pregnancy (approximately half suspected pregnant, most in early stage
§ 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.