(153 days)
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.
This product is intended for prescription use in clinical laboratories and point-of-care use settings.
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.
This product is intended for prescription use in clinical laboratories and point-of-care use settings.
Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
Here's an analysis of the acceptance criteria and study details for the Assure Tech hCG Pregnancy Serum/Urine Combo Test, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to its "precision/reproducibility/cut-off value" and "method comparison" studies. The goal is to perform accurately around the established cut-off values and show strong agreement with a predicate device.
| Acceptance Criteria (Inferred from Study Outcomes) | Reported Device Performance |
|---|---|
| Precision/Reproducibility: Establish accurate detection at and around cut-off values. | Serum Cut-off (10 mIU/mL): |
| - At 8 mIU/mL (below cut-off), device showed ~48-49% positive results (some false positives, but expected given proximity to cut-off). | |
| - At 10 mIU/mL (cut-off), device showed 100% positive results. | |
| - At 0, 4, 6 mIU/mL (negative controls), device showed 100% negative results. | |
| Urine Cut-off (20 mIU/mL): | |
| - At 16 mIU/mL (below cut-off), device showed ~51-53% positive results (some false positives, but expected given proximity to cut-off). | |
| - At 20 mIU/mL (cut-off), device showed 100% positive results. | |
| - At 0, 5, 10, 12 mIU/mL (negative controls), device showed 100% negative results. | |
| Method Comparison: Demonstrate substantial equivalence to a legally marketed predicate device. | 100% agreement between the Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette/Strip) and the predicate device (QuickVue+) for: |
| - Urine Strip: 60 positive, 60 negative samples (100% agreement with predicate). | |
| - Urine Cassette: 60 positive, 60 negative samples (100% agreement with predicate). | |
| - Serum Strip: 60 positive, 60 negative samples (100% agreement with predicate). | |
| - Serum Cassette: 60 positive, 60 negative samples (100% agreement with predicate). | |
| Stability: Maintain performance over time. | Stable at 4-30°C for 24 months (based on accelerated stability at 50°C and real time stability at 4°C and 30°C). |
| Specificity/Cross-Reactivity: No significant interference from related hormones. | No interference observed for LH, FSH, and TSH at tested concentrations (up to 300 IU/mL LH, 1000 mIU/mL FSH, 1000 µIU/mL TSH). False positive was observed above 200 pmol/L ß-core fragment hCG. No hook effect observed up to 2,000,000 mIU/mL hCG. |
| Interference: No significant interference from common exogenous or endogenous substances. | No interference observed for a wide range of compounds (e.g., Acetaminophen, Acetoacetic Acid, Ascorbic Acid, Bilirubin, Caffeine, Ethanol, Glucose, Hemoglobin, Lipoprotein, etc.) at stated concentrations and within specified read times. No interference from urine pH (4-9) or specific gravity (1.000-1.035). |
Study Details
- Sample Size and Data Provenance:
- Test Set (Precision/Reproducibility): For each format (Serum Strip, Serum Cassette, Urine Strip, Urine Cassette), 150 replicates were used for each hCG concentration level (10 replicates per site x 3 sites x 5 days for each of 3 lots = 450 total data points per concentration level for each format). Total tests: 10 concentrations per serum format, 10 for urine strip, 10 for urine cassette. This would be a massive number, but the table combines the three lots and three operators. So for each concentration, 150 total tests (3 sites x 50 tests per site). This means for Serum Strip, 150 tests at 0 mIU/mL, 150 tests at 4 mIU/mL, and so on.
- Provenance: This data was generated in vitro by spiking negative serum/urine specimens with hCG. The origin of the negative serum/urine is not specified (e.g., country) but is likely lab-obtained.
- Test Set (Method Comparison): 120 urine samples and 120 serum samples were collected.
- Provenance: The samples were collected prospectively from 120 women (ages 18-49, about half pregnant and in early stages
- Test Set (Precision/Reproducibility): For each format (Serum Strip, Serum Cassette, Urine Strip, Urine Cassette), 150 replicates were used for each hCG concentration level (10 replicates per site x 3 sites x 5 days for each of 3 lots = 450 total data points per concentration level for each format). Total tests: 10 concentrations per serum format, 10 for urine strip, 10 for urine cassette. This would be a massive number, but the table combines the three lots and three operators. So for each concentration, 150 total tests (3 sites x 50 tests per site). This means for Serum Strip, 150 tests at 0 mIU/mL, 150 tests at 4 mIU/mL, and so on.
§ 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.