(53 days)
MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human 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® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human 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® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
Here is a summary of the acceptance criteria and study details for the MissLan® Pregnancy Rapid Test (Strip) and MissLan® Pregnancy Rapid Test (Midstream), based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Analytical Sensitivity (Detection Limit) | 25 mIU/mL hCG detectable with 100% positive rate. | Achieved 100% positive results for 25 mIU/mL hCG across all operators, lots, and formats (Midstream (in-stream & dip), Strip). | Confirmed. |
| Reproducibility | Consistent results across different operators, lots, and days. | Observed reproducibility of results for all formats with varying hCG concentrations. (e.g., 25 mIU/mL consistently 100% positive, 0 and 12.5 mIU/mL consistently 100% negative). | Confirmed. |
| Hook Effect | No hook effect observed at high hCG concentrations. | No hook effect observed up to 500,000 mIU/mL hCG, all samples tested positive. | Confirmed. |
| Specificity (False Positives) | No false positive results in non-pregnant individuals. | No false positive results observed in 450 urine samples from normal, non-pregnant females across three age groups and all device formats. | Confirmed. |
| Cross-Reactivity | No cross-reactivity with hLH, hFSH, or hTSH at specified concentrations. | No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH. | Confirmed. |
| hCG ß-core fragment Interference | No interference from hCG ß-core fragment at specified concentrations. | Performance not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L. | Confirmed. |
| Exogenous & Endogenous Interfering Substances | No interference from a panel of common substances at specified concentrations. | No interference effect observed for the listed substances (e.g., Glucose, Albumin, Hemoglobin, common medications) at tested concentrations. | Confirmed. |
| Urine pH Effect | Performance unaffected by urine pH within a specific range. | Performance unaffected by urine pH ranging between 4 and 9. | Confirmed. |
| Urine Density Effect | Performance unaffected by urine density within a specific range. | Performance unaffected by urine with a relative density up to 1.035. | Confirmed. |
| Method Comparison (Conformity with Predicate) | 100% conformity with the predicate device for positive and negative samples. | 100% conformity achieved between MissLan® Pregnancy Rapid Test (all formats) and the predicate device across tested urine samples. | Confirmed. |
| Lay Person Study (Accuracy of Self-Testing) | 100% concordance with professional results for positive and negative samples; 100% correct results for spiked samples (5 mIU/mL negative, 25 mIU/mL positive); ease of use and readability of labeling. | Achieved 100% positive and 100% negative conformity with professional results in the first study (100 women per format). Achieved 100% correct results for 5 mIU/mL and 25 mIU/mL spiked samples in the second study (100 laypersons per concentration). Questionnaire confirmed ease of use and understanding. | Confirmed. |
2. Sample Size for Test Set and Data Provenance
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Analytical Performance (Precision/Reproducibility/Sensitivity):
- For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots. This means 50 tests per operator/lot/concentration.
- Total tests for Strip format: 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
- Total tests for Midstream format (in-stream): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
- Total tests for Midstream format (dip): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
- Total for Sensitivity: 4050 unique test interpretations.
- Data Provenance: Not explicitly stated, but likely laboratory-prepared samples.
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Specificity (Cross-reactivity with non-pregnant samples):
- Sample Size: 450 urine samples (150 from pre-menopausal, 150 from peri-menopausal, 150 from post-menopausal women).
- Each age group had 50 participants tested with strip, 50 with midstream (dip), and 50 with midstream (in-stream).
- Data Provenance: Not explicitly stated but implies prospective collection of urine from normal, non-pregnant females.
-
Method Comparison Study:
- Sample Size: 200 urine samples (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.