(119 days)
The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum.
The method employs a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity using a unique patented membrane technology. In less than 5 minutes, elevated levels of hCG as low as 25 mIU/ml can be detected. If the test is to be used on serum the sample must be diluted according to the directions for the One Step™ Pregnancy hCG serum diluent (cat XXXX). As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative zone. Unbound conjugate binds to the reagents in the negative control zone, producing a pink-rose (magenta) color band, demonstrating that the reagents and device are functioning correctly.
Acceptance Criteria and Study Findings for One Step™ Pregnancy hCG Strip
This document summarizes the acceptance criteria and the study that demonstrates the One Step™ Pregnancy hCG Strip meets these criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity | Detect hCG levels as low as 25 mIU/ml | 25 mIU/ml |
| Specificity | No interference from other substances/hormones | No apparent interferences from tested substances; no cross-reactivity noted with other hormones. |
| Accuracy (Overall Test) | Correctly identify pregnant/not pregnant cases with no false negatives or positives in a blind study | 100% agreement with documented patient samples (150 samples: 90 pregnant, 60 not pregnant). No false negatives or positives. |
| Accuracy (Serum Diluent Extension) | 100% agreement with reference methods for serum/plasma samples | 100% agreement with reference methods in 385 patient comparisons. |
| Functionality | Control line appears, demonstrating proper reagent and device function | Unbound conjugate binds to reagents in the negative control zone, producing a pink-rose (magenta) color band. (Implicitly met if results are accurate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size:
- For the initial blind study: 150 documented patient samples (90 pregnant and 60 not pregnant).
- For the serum/plasma diluent extension: 385 patient comparisons.
- Data provenance: Not explicitly stated (e.g., country of origin). Both studies appear to be prospective as they involved testing patient samples or patient comparisons.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of experts: Not explicitly stated.
- Qualifications of experts: The text mentions "documented (Pregnant/not pregnant) patient samples" for the initial study and "reference methods" for the serum/plasma study. It does not provide details on the specific qualifications of those who provided the "documentation" or performed the "reference methods."
4. Adjudication Method for the Test Set
- Adjudication method: Not explicitly stated. For the initial study, the "documented" status of the patient samples served as the ground truth. For the serum/plasma extension, "reference methods" were used for comparison. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The provided text describes studies comparing the device's performance to documented patient status or reference methods, not comparing human readers' performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes. The studies described evaluate the performance of the One Step™ Pregnancy hCG strip itself, as a standalone diagnostic device. The results (e.g., 100% accuracy, 25 mIU/ml sensitivity) reflect the device's intrinsic capabilities.
7. Type of Ground Truth Used
- For the initial blind study: The ground truth was based on "documented (Pregnant/not pregnant) patient samples." This likely refers to a clinical diagnosis confirmed by other means (e.g., medical history, other tests).
- For the serum/plasma diluent extension: The ground truth was established by "reference methods" (e.g., laboratory-based hCG assays).
8. Sample Size for the Training Set
- Sample size for training set: The document does not provide information about a specific "training set" for the device, as it's a lateral flow immunoassay rather than an AI/machine learning algorithm. The "extensive testing against substances known to interfere" and "specificity... tested against other hormones" can be considered part of the development/calibration process, but a distinct "training set" as understood in AI context is not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
- How ground truth was established for training set: Not applicable, as there is no specific training set described in the context of an AI algorithm learning from data. The device's performance characteristics (sensitivity, specificity) are established through analytical testing and clinical validation against known samples/standards.
§ 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.