(54 days)
The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.
The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.
Not Found
The Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo are intended for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy. The study demonstrates the substantial equivalence of the Unotech devices to the Quidel QuickVue hCG Combo Test.
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Agreement with Predicate Device (Urine) | 100% agreement with Quidel QuickVue hCG Combo Test | 100% agreement (48 positive, 46 negative) |
| Agreement with Predicate Device (Serum) | 100% agreement with Quidel QuickVue hCG Combo Test | 100% agreement (42 positive, 45 negative) |
| Sensitivity (minimum detectable hCG concentration) | Detect hCG at levels as low as 25 mIU/mL | Detects hCG at 25 mIU/mL (10/10 samples positive) |
| Sensitivity (maximum detectable hCG concentration) | Detect hCG at levels as high as 1,000,000 mIU/mL | Detects hCG at 1,000,000 mIU/mL (10/10 samples positive) |
| Specificity (negative control) | No false positives at 0 mIU/mL hCG | 0 positives at 0 mIU/mL hCG (0/10 samples positive) |
Study Details
2. Sample Sizes and Data Provenance
- Comparison Study:
- Test Set Size: 181 specimens (94 urine specimens, 87 serum specimens).
- Data Provenance: The document does not explicitly state the country of origin, but it mentions "patients seeking confirmation of pregnancy," suggesting clinical samples. The study appears to be retrospective, using collected specimens.
- Sensitivity Study:
- Test Set Size: 60 urine samples and 60 serum samples (10 samples for each of the 6 hCG concentrations tested for both urine and serum).
- Data Provenance: Negative pooled urine and serum specimens were "spiked with hCG," indicating a controlled laboratory setting.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The ground truth for the comparison study was established by the predicate device (Quidel QuickVue hCG Combo Test). For the sensitivity study, the ground truth was based on the known spiked concentrations of hCG.
4. Adjudication Method
- Not applicable. Ground truth was established by the predicate device or known concentrations, not by expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case comparative effectiveness study was not done. This study is for an in-vitro diagnostic device, not an AI or imaging device requiring human reader interpretation enhancement.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The performance of the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo was evaluated directly against a predicate device and against known spiked concentrations without human interpretation as part of the primary outcome.
7. Type of Ground Truth Used
- Comparison Study: Reference standard (predicate device - Quidel QuickVue hCG Combo Test) results.
- Sensitivity Study: Known concentrations of hCG in spiked samples.
8. Sample Size for the Training Set
- Not applicable. This is an in-vitro diagnostic device study, not an AI/machine learning study that typically involves training sets.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there was no training set in the context of an AI/machine learning model.
§ 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.