(102 days)
Shinetell Plus™ Digital Early Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
Shinetell Plus™ Digital Early Pregnancy 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.
Shinetell Plus™ Digital Early Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
Here's a breakdown of the acceptance criteria and study information for the Shinetell Plus™ Digital Early Pregnancy Test, based on the provided 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter does not explicitly state "acceptance criteria" as a separate, quantitative table. However, we can infer the acceptance criteria from the performance studies presented, particularly the sensitivity and agreement rates. The primary criterion is demonstrating a sensitivity of 10 mIU/mL and high agreement with professional results and the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LOD) | 10 mIU/mL (based on predicate and stated sensitivity) | Midstream & Dip Testing: 100% positive at 10 mIU/mL hCG. |
| Cross-Reactivity | No false positives with related hormones (hLH, hFSH, hTSH) | No cross-reactivity observed with 1000 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 μIU/mL hTSH. Not affected by hCG β-core fragment up to 500,000 pmol/L. |
| Interference | No interference from common substances or urine properties | No interference observed at specified concentrations for various substances (Acetaminophen, Acetylsalicylic acid, Ascorbic acid, Atropine, Caffeine, Gentisic acid, Glucose, Hemoglobin, Tetracycline, Ampicillin, Albumin, β-hydroxybutyrate, Ephedrine, Phenylpropanolamine, Phenothiazine, EDTA, Salicyclic Acid, Benzoylecgonine, Cannabinol, Codeine, Ethanol, Bilirubin, Pregnanediol, Thiophene, Ketone). No effect from urine pH (4-9) or density (1.000-1.035). |
| Hook Effect | No hook effect up to clinically relevant high concentrations | No hook effect observed up to 500,000 mIU/mL hCG. |
| Clinical Agreement (vs. Predicate) | High agreement (e.g., >95%) with predicate device | Dip Testing: 100% conformity (49 Pos, 51 Neg vs Predicate). Midstream Testing: 100% conformity (48 Pos, 52 Neg vs Predicate). |
| Lay Person Readability & Interpretation | High agreement (e.g., >95%) between lay user and professional results; ease of use; clear labeling | In-Stream Method: 100% positive and 100% negative conformity with professional results (48 Pos, 52 Neg). Dip Method: 100% positive and 100% negative conformity with professional results (49 Pos, 51 Neg). Lay person results for spiked samples showed 98-100% agreement with professional results. Questionnaires indicated ease of use and clear labeling. |
| Early Detection Performance | Detect pregnancy early (e.g., 5 days before EMP) | Detected 67.7% positive hCG five days before the Expected Menstrual Period (EMP). Detected 100% positive hCG on the day of EMP. |
| Stability | Stable for a reasonable shelf life | 24 months at 35.6-86°F (based on real-time stability study). |
2. Sample Sizes and Data Provenance
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Analytical Performance (Precision/Reproducibility/Sensitivity):
- Test Set Sample Size: For each hCG concentration (0, 3, 5, 7.5, 8, 10, 25, 50 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots, by 3 different operators. This sums to (8 concentrations * 10 replicates/day * 5 days * 3 lots) = 1200 tests for Midstream and another 1200 tests for Dip Testing.
- Data Provenance: Not explicitly stated, but typically these are laboratory-controlled, prospective studies with spiked samples. The hCG standard is traceable to the 5th WHO.
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Specificity (Non-pregnant females):
- Test Set Sample Size: 300 urine samples (100 from pre-menopausal, 100 from peri-menopausal, 100 from post-menopausal women).
- Data Provenance: Not explicitly stated, but implies prospectively collected urine samples from healthy non-pregnant females.
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Method Comparison Study (vs. Predicate):
- Test Set Sample Size: Urine samples from 200 women suspected to be pregnant in the 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.