(210 days)
Macro & Micro-Test HCG Pregnancy Test Midstream is intended for over-the-counter use for qualitative detection of hCG hormone in urine to aid early detection of pregnancy.
Macro & Micro-Test HCG Pregnancy Test Midstream is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. The midstream kits consist of one test device and a package insert. The test device contains mouse monoclonal anti- B hCG antibody coated membrane and a pad containing mouse monoclonal anti- a -hCG antibody colloidal gold conjugate. The control antibodies are goat anti-rabbit IgG.
The provided document is a 510(k) summary for the Macro & Micro-Test HCG Pregnancy Test Midstream. It contains information about the device's acceptance criteria and the studies performed to demonstrate its performance.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| LoD/Sensitivity (Detection Limit) | 25 mIU/mL: The results indicate that the positive detection rate is more than 95% when the concentration is not less than 25 mIU/mL. |
| Consistency/Agreement with Predicate | 100% agreement (Positive Percent Agreement, Negative Percent Agreement, Total Percent Agreement) with the predicate device (midstream version) for 250 urine samples. |
| Lay User Agreement with Professionals | 100% agreement between lay user results and professional results for 250 urine samples. Lay users also found the product instructions easy to understand and devices easy to use. |
| Precision/Reproducibility | Consistent and precise test results across 3 batches, 3 sites, 5 days, and 10 replicates per day for various hCG concentrations (0, 12.5, 18.75, 25, 50, 100 mIU/mL). Example: For 25 mIU/mL, 100% positive across all sites; for 0 and 12.5 mIU/mL, 100% negative across all sites. At 18.75 mIU/mL, 53.33% positive and 46.67% negative, reflecting expected near-LoD performance. |
| Specificity (Cross-reactivity) | No cross-reaction observed with hLH at 500mIU/ml, hFSH at 1000 mIU/mL, and hTSH at 1000 µIU/mL. |
| Interfering Substances | No interference observed from 29 common exogenous compounds (e.g., Acetaminophen, Caffeine, Hemoglobin, Vitamin C, Glucose, Bilirubin, etc.) at specified concentrations in both positive (25mIU/mL hCG) and negative urine samples. |
| Effects of Urine pH | No interference observed for urine pH range of 4-9 (tested with 0 and 25mIU/mL hCG). |
| Effects of Urine Specific Gravity | No interference observed for urine with specific gravity 1.000-1.035 (tested with 0 and 25mIU/mL hCG). |
| High Dose Hook Effect | No high dose hook effect for hCG concentrations up to 1,000,000 mIU/mL (Note: The study in section H.h only tested up to 1000IU/ml, which is 1,000,000 mIU/mL. The table in G indicates a claim of no hook effect up to 1,000,000 mIU/mL). |
| Beta hCG Core Fragment Reactivity | No interference observed when the concentration of HCG ß-core fragment reaches 1 µmol/L. |
| Read Time | Optimal interpretation within 5-10 minutes. Test result was "most accurate" when interpreted within this window (tested at 5, 15, 20, and 30 minutes). |
| Shelf Life | 24 months when stored at 4-30°C. |
| Quality Control | Appearance of a red band at the control line (C) and a clear background in the results window. |
2. Sample Sizes Used for the Test Set and the Data Provenance:
- Consistency Study (Comparison with Predicate): 250 urine samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "Urine samples were selected from 250 women aged from 18-55 years old." It doesn't specify if the study was retrospective or prospective. Given the testing methodology described, it appears to be a prospective collection or at least a prospective testing of collected samples.
- OTC Lay User Test: 250 urine samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "women aged from 18-55 years old". It seems to be a prospective study, as participants were given the device to test samples and questionnaires were administered.
- Precision/Reproducibility Study: 900 urine samples (across 6 concentrations: 0, 12.5, 18.75, 25, 50, 100 mIU/mL; 3 sites x 5 days x 10 replicates per concentration).
- Data Provenance: Not explicitly stated, but conducted at "3 sites (one internal site and two external sites representative of the intended use setting)." This suggests the study was conducted within a controlled setting.
- LoD/Sensitivity Study: 30 negative samples used to dilute WHO International Standard hCG to various concentrations (0, 12.5, 18.75, 25, 50, and 100 mIU/mL). The number of test replicates at each concentration for LoD determination is not explicitly stated, but the precision study data for similar concentrations would provide insight into reproducibility near the LoD.
- Data Provenance: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Consistency Study: Test results were compared between the candidate device and the predicate device. For the candidate device, testing was done by "three different health professionals at each of three sites for a total of three operators." The predicate device results would likely also have been generated by trained professionals.
- Qualifications: "Health professionals" are mentioned, but specific qualifications (e.g., "Radiologist with 10 years of experience") are not provided.
- OTC Lay User Test: "The same urine samples were tested by professionals in parallel using the proposed device." These professional results served as the ground truth against which lay user results were compared.
- Qualifications: "Professionals" are mentioned, but specific qualifications are not detailed beyond that.
- Analytical Studies (Specificity, Interfering Substances, pH, Specific Gravity, High Dose Hook, Beta hCG Core Fragment Reactivity, LoD, Read Time, Precision): The ground truth for these studies was established by preparing urine samples with known concentrations of hCG, interferents, or specific environmental conditions, traceable to international standards (e.g., WHO 6th IS for hCG). This relies on laboratory standards and scientific measurement rather than expert interpretation of results.
4. Adjudication Method for the Test Set:
- Consistency Study & OTC Lay User Test: No explicit detailed adjudication method (like 2+1, 3+1) is described. The agreement was calculated based on direct comparison of results. For the consistency study, the "agreement of hCG pregnancy test midstream with the predicate device was 100%," implying direct concordance. For the lay user study, "100% agreement between lay user results and professional results" also indicates direct concordance. This suggests a direct comparison method.
- Analytical Studies: Adjudication is not typically applicable for these types of controlled analytical tests where known quantities are used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This document pertains to an in vitro diagnostic (IVD) device (pregnancy test midstream) rather than an AI-powered diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a standalone test kit (a lateral flow immunoassay), not an algorithm or an AI-based system. Its performance is inherent to the chemical reactions and visual interpretation, which can be done by a human (lay user or professional). The term "standalone" in the context of AI algorithms is not directly applicable here. The device itself is the "standalone" diagnostic tool. The document does report its performance when used by professionals (which can be considered the equivalent of "algorithm only" in this context, as professionals are interpreting the device's output) and by lay users.
7. The type of ground truth used:
- For consistency and lay user studies: The results from the predicate device (or professional testing in the case of the lay user study) served as a comparative ground truth.
- For analytical performance studies (LoD, Precision, Specificity, Interfering Substances, pH, Specific Gravity, High Dose Hook, Beta hCG Core Fragment Reactivity): Laboratory-prepared samples with known concentrations of analytes (hCG) or interferents, traceable to international standards (e.g., WHO 6th IS for hCG), were used to establish the ground truth. This is a highly controlled and quantitative ground truth.
8. The sample size for the training set:
- This document describes performance studies for a traditional in vitro diagnostic (IVD) lateral flow immunoassay (not an AI/ML device). Therefore, there is no concept of a "training set" in the context of machine learning model development. The samples tested in the studies described are for performance evaluation and validation.
9. How the ground truth for the training set was established:
- As stated above, this is not an AI/ML device, so there is no training set and thus no ground truth established for a training set in this context.
§ 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.