(81 days)
The AZOG hCG One-Step (Urine) Pregnancy Test Strip (DipStick) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
AZOG, INC. ACG one-step. Vrine Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine the test is for professional use only.
The AZOG hCG One-Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by immersing the test strip in a urine specimen and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
Here's a breakdown of the acceptance criteria and study details for the AZOG,Inc. Urine Pregnancy Test Strip:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Agreement | 100% (with a similar predicate device) |
| Accuracy | ≥ 99% |
| Sensitivity (Detection Limit) | Detects hCG at 25 mIU/mL or greater |
| Cross-Reactivity (LH, FSH, TSH) | No cross-reactivity at 1000 mIU/mL LH, 1000 mIU/mL FSH, and 1000 µIU/mL TSH |
| Interference | None of the potentially interfering substances tested interfered |
| Precision/Tolerance (Within-run) | No differences observed across 5 replicates |
| Precision/Tolerance (Between-run/Day) | No differences observed across three different assay days |
| Precision/Tolerance (Between-operator) | No differences observed between two operators |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 150 urine specimens were used for the correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "a panel of 3 coded specimens" for precision/tolerance and "150 urine specimens" for correlation. Given the nature of a pregnancy test, these would typically be human urine samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable or not specified. For this type of device, the "ground truth" is typically established by comparing its results to a known reference method or a predicate device, rather than expert interpretation of images or clinical data.
- Qualifications of Experts: Not applicable, as expert consensus was not the primary method for ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for the correlation study was established by comparing the device's results to those obtained from a "similar device," implying either a predicate device or a well-established laboratory method. There was no mention of multiple human readers or a need for adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study (MRMC) is typically performed for imaging diagnostic devices where human interpretation plays a significant role and AI aims to assist or replace human readers. The AZOG hCG One-Step Urine Pregnancy Test Strip is a rapid immunoassay that provides a direct qualitative result, not requiring a human interpretation loop in the same way.
- Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, essentially. The stated performance metrics (100% overall agreement, 99% accuracy, sensitivity, specificity, cross-reactivity, interference, precision) reflect the standalone performance of the device itself (the "algorithm" in a chemical assay context) reacting with urine samples. The device is designed to provide a direct readout without requiring human intervention for result interpretation beyond observing the colored lines.
7. Type of Ground Truth Used
- Ground Truth Type:
- Correlation Study: Comparison to results obtained from a "similar device" (likely a legally marketed predicate device or a validated laboratory method).
- Sensitivity: Defined by the ability to detect a specific concentration of hCG (25 mIU/mL or greater) in spiked samples. This is a form of analytical ground truth.
- Cross-Reactivity/Interference: Determined by testing known concentrations of interfering substances with negative and positive hCG samples. This is also analytical ground truth.
- Precision/Tolerance: Established by testing coded specimens with known hCG levels (negative, low positive, high positive). This involves using known spiked/controlled samples as ground truth.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The device's performance is based on its chemical and biological components, which are developed and optimized through laboratory testing, rather than an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the context of an AI training set. The development and optimization of the immunoassay (analogous to "training") would involve internal validation using known concentrations of hCG, potentially spiked with interferents, and comparison to established reference methods or predicate devices to ensure the assay components (antibodies, membrane, reagents) function as intended. This would involve a continuous process of testing and refinement during product development.
§ 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.