(98 days)
ACESO 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.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This device is intended for home-use only.
ACESO 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.
The provided document is a 510(k) summary for the ACESO Early Pregnancy Test, a qualitative human chorionic gonadotropin (hCG) test system. It details the device's performance characteristics and studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided information, framed around acceptance criteria and the study that proves the device meets them:
Device: ACESO Early Pregnancy Test
Intended Use: 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). Intended for home use only.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a separate table, but rather presents performance data that implicitly serves as the proof for meeting certain thresholds. Based on the studies performed, the following can be inferred as intended performance and the results obtained:
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (Limit of Detection) | Reproducible detection of 10 mIU/mL hCG. | 10 mIU/mL. Both dip and midstream testing showed 100% positive results for 10 mIU/mL and higher concentrations of hCG across 3 lots and 3 operators. For 8 mIU/mL, 95% (dip) and 97% (midstream) positive detection was observed. |
| Precision/Reproducibility | Consistent results across different lots, operators, and replicates. | Reproducible results exhibited. For 10 mIU/mL and above, 100% positive agreement was observed across 3 lots, 10 replicates for 10 days, tested by 3 operators. |
| Hook Effect | No hook effect up to high hCG concentrations. | No hook effect observed up to 500,000 mIU/mL. All tested concentrations (up to 500,000 mIU/mL) gave a positive result. |
| Specificity (Cross-reactivity, pH, Density, Interfering Substances) | No false positives from non-pregnant females. No interference from common cross-reactants or interfering substances within specified physiological ranges. | Specificity (Non-pregnant females): 100% specificity (No false positives) observed in 300 urine samples from healthy non-pregnant females across pre-, peri-, and post-menopausal groups. |
| Cross-reactivity: No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 uIU/mL hTSH, or hCG ß-core fragment up to 500,000 pmol/L. | ||
| Interfering substances: No interference observed from 20 listed substances (e.g., acetaminophen, aspirin, caffeine, glucose, hemoglobin) at specified concentrations. | ||
| Urine pH: No effect on performance for urine pH between 4 and 9. | ||
| Urine Density: No effect on performance for urine density up to 1.035. | ||
| Method Comparison (vs. Predicate Device) | 100% conformity with the predicate device. | 100% conformity. In a study of 100 urine samples from women presenting for pregnancy testing, the ACESO device showed 100% positive and 100% negative agreement with the predicate device for both dip and midstream testing. |
| Lay Person Study (Usability and Interpretation) | High conformity (e.g., >95%) between lay person results and professional/expected results, and high user comprehension. | High Conformity & User Comprehension. Self-testing by 100 women showed 100% positive and 100% negative conformity with professional results for clinical samples. For spiked samples, agreements were: 100% at 3 mIU/mL, 97% at 5 mIU/mL, 99% at 8 mIU/mL, and 100% at 10 mIU/mL. Questionnaire results reflected consumers found the test easy to use and understood labeling/interpretation. |
| Early Pregnancy Detection (Clinical Performance) | Detect hCG as early as 5 days before expected period, reaching 100% detection on/around the expected menstrual period (EMP). | 76.9% positive hCG detected 5 days before EMP. 100% positive hCG detected from 3 days before EMP through EMP+1. |
2. Sample Sizes Used for the Test Set and Data Provenance
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Analytical Performance (Precision/Sensitivity):
- Sample Size: For each hCG concentration (0, 3, 5, 8, 10, 15, 25, 50 mIU/mL), 10 replicates were tested per day for 10 days for each of 3 device lots. This totals 10 * 10 * 3 = 300 tests per concentration, for a grand total of 8 concentrations * 300 tests/concentration = 2400 tests for each testing method (dip and midstream).
- Data Provenance: Negative female urine was spiked with hCG standard (Traceable to the 5th WHO). This is prospective, laboratory-controlled spiking for analytical validation. The document does not specify the country of origin of the source urine, but it's likely from a lab collection.
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Specificity (Non-pregnant females):
- Sample Size: 300 urine samples.
- Data Provenance: Collected from healthy, non-pregnant females (100 each from pre-menopausal, peri-menopausal, and post-menopausal groups). This is prospective, clinical sample collection. No country of origin is specified.
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Hook Effect Test:
- Sample Size: Not specified in terms of number of individual tests, but varying hCG concentrations were spiked into negative urine samples.
- Data Provenance: Laboratory-controlled spiking.
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Method Comparison Study:
- Sample Size: 100 urine samples.
- Data Provenance: Collected from women presenting to test for pregnancy, with approximately half suspected of early pregnancy (
§ 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.