(49 days)
The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also rne vioron moditor Haman Sherion's designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now done ourick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCGml of human urine. VicTorch hCG Test Strip devices are intended to meet all requirements for rioUing rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of ylolang rapid, outlif rodal quality of the may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Strip devices are designed for professional use nor of of of over to over (viran analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
The VicTorch hCG Test Strip device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) at the cutoff level of 20 mlU/ml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Strips are used to aid in the diagnosis of pregnancy.
Here's a breakdown of the acceptance criteria and the study that demonstrates the VicTorch hCG Test Strip device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity | Consistently detect 20 mlU hCG/ml or greater hCG in human urine. | "Sensitivity studies that includes 20% above and below 20 mlU hCG/ml cutoff concentration and other 0 to 100 mlU hCG/ml levels that indicated the VicTorch hCG Test Strip can consistently detect 20 mlU hCG /ml or greater hCG in human urine as it claimed." |
| Specificity (Cross-reactivity) | No cross-reactivity with structurally related hormones such as 500 mlU/ml of LH, 1000 µlU/ml of TSH, and 1000 mlU/ml of FSH. | "Specificity studies against other structurally related hormones such as 500 mlU/ml of LH, 1000 µlU/ml of TSH, and 1000 mlU/ml of FSH that shown that these hormones do not cross-react with the VicTorch hCG Test Strip at the indicated test levels." |
| Interference | No interference (no false positive or false negative results) from common OTC, prescription, abuse drugs, chemical analytes, and pH (within normal urine range). | "Interference studies against analytes commonly found in OTC, prescription and/or abuse drugs proved that those drugs, chemical analytes, and pH (varied within normal range for human urine) did not interfere VicTorch hCG Test Strip performance, yielding no false positive or false negative results." |
| Specimen Collection and Storage | Valid performance when tested for urine specimens refrigerated for up to three days (for both hCG negative and positive samples). | "The Specimens Collection and Storage studies on both hCG negative and hCG positive urine specimens validated the VicTorch hCG Test Strip devices when tested for urine specimens refrigerated for up to three days." |
| Accuracy (Clinical Performance) | Complete agreement with a predicate approved hCG assay device (ABI's SureStrip™ hCG Test); at 95% Confidence = 99.1-99.8%. This implies a target for sensitivity and specificity in a clinical setting against a known accurate device. | "Accuracy studies at an external OBGYN clinical center on 172 female patients (with 91 hCG positive and 81 hCG negative) gave complete agreement (accuracy = 100%) with the ABI's SureStrip™ hCG Test, the predicate approved hCG assay device... Relative Accuracy = Total # of VicTorch hCG Test Strip agreed with SureStrip™ / Total # of ABI SureStrip™ tested x 100% = 172/172 x 100% = 100%, with at 95% Confidence = 99.1-99.8%" |
| Stability | Performance stable for at least one year from the time of manufacture (based on accelerated and real-time evaluations). | "In house stability study for both accelerated and real time evaluations showed that the performance of VicTorch hCG Test Strip was stable for at least one year from the time of being manufactured." |
| Substantial Equivalence | Function as effectively as other FDA approved and currently marketed similar hCG test devices, specifically being substantially equivalent to ABI's SureStrip™ hCG pregnancy rapid tests devices for professional use qualitative urinary assay of hCG at the required cut-off of 20 mlU/mL. | "Support data collected from the above evaluation and accuracy studies... indicate substantial equivalence of this newly designed VicTorch hCG Strip with the predicate approved hCG assay device." and "We can conclude that VicTorch hCG Test Strip devices are substantially equivalent to currently marketed ABI's SureStrip™ hCG pregnancy rapid tests devices for professional use qualitative urinary assay of hCG at the required cut-off of 20 mlU/mL." |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Accuracy Study (Clinical Performance Test Set):
- Sample Size: 172 female patients.
- 91 hCG positive patients
- 81 hCG negative patients
- Data Provenance: Retrospective (implied, as patients were recruited and tested, then compared to results from a predicate device). The study was conducted at an "external OBGYN clinical center." The country of origin is not explicitly stated but can be inferred to be the USA given the FDA submission.
- Sample Size: 172 female patients.
-
Other Studies (Sensitivity, Specificity, Interference, Specimen Collection & Storage, Stability):
- Specific sample sizes for these analytical studies (e.g., number of urine samples spiked for sensitivity, number of samples with interfering substances) are not detailed in the provided text. The text only describes the types of studies conducted and their positive outcomes.
- Data Provenance: These appear to be laboratory-based analytical studies, likely conducted "in-house" or by contract labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for the clinical accuracy study was established by the predicate device, ABI's SureStrip™ hCG Test. The text does not mention human experts establishing ground truth for individual cases in the test set. Instead, it relies on the established accuracy and FDA approval of the predicate device.
4. Adjudication Method for the Test Set
- None specified for human review. The adjudication was by direct comparison of the VicTorch hCG Test Strip results to the results of the ABI's SureStrip™ hCG Test. Any discrepancies would presumably have been investigated, but the text states "complete agreement (accuracy = 100%)" which suggests no adjudication of conflicting results was necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The device is a qualitative, visual test strip intended for professional use, but the study described is a comparison of the device's output against a predicate device, not a study of human reader performance with and without AI assistance. The "AI" in this context is the test strip itself, providing a direct visual result.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, the entire evaluation is a standalone performance assessment. The VicTorch hCG Test Strip device is designed to provide a direct visual result (color change) without requiring further algorithms or human interpretation beyond reading the positive/negative indicator. The studies (sensitivity, specificity, interference, accuracy) all assess the device's inherent performance.
7. Type of Ground Truth Used
- For the accuracy study (clinical performance), the ground truth was based on the results from a legally marketed and FDA-approved predicate device (ABI's SureStrip™ hCG Test).
- For the analytical studies (sensitivity, specificity, interference), the ground truth would have been established by known concentrations of hCG, known concentrations of interfering substances, and known concentrations of cross-reactive substances, which is a form of reference standard or spike-in validation.
8. Sample Size for the Training Set
- Not applicable / Not specified. This device is a qualitative immunochromatographic test strip, not a software algorithm that requires a "training set" in the machine learning sense. Its performance is based on its chemical/biological design and manufacturing, not learned from data. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this device does not utilize a training set in the context of machine learning. Its "ground truth" is inherent to its design and the chemical reactions it facilitates.
§ 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.