(174 days)
The Polymed Therapeutics' Fastep™ At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy.
Polymed Therapeutics' FastepTM At-Home Pregnancy Test is intended to be distributed for Over-the-Counter (OTC) use.
Polymed Therapeutics' Fastep™ At-Home Pregnancy Test utilizes monoclonal antibody reagents to selectively detected elevated levels of hCG in urine specimen at the sensitivity of 20mIU/mL. It is designed to be tested in midstream and dipstick mode. The Fastep™ At-Home Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The result is generated by immersing the tip in the urine stream or urine cup for a sufficient amount of time to absorb an adequate sample volume. Each test reagent strip consists of a mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
Acceptance Criteria and Study for Fastep™ At-Home Pregnancy Tests
Here's an analysis of the acceptance criteria and the study conducted for the Fastep™ At-Home Pregnancy Tests (K122907), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. However, it implicitly uses the performance of the predicate device (Teco Diagnostics One-Step Midstream Pregnancy Test, K974059) and confirmed hCG quantitative levels as benchmarks for substantial equivalence. The reported performance is as follows:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Agreement with Predicate Device (Lay Users) | "A minimum of 92.7% agreement" | 92.7% agreement with Teco Midstream Pregnancy Test (K974059) |
| Agreement with Confirmed hCG Quantitative Level (Lay Users - Main Study) | "100% agreement" | 100% agreement with confirmed hCG quantitative level of tested specimens |
| Agreement with Confirmed hCG Quantitative Level (Lay Users - Near-cutoff) | "100% agreement" | 100% agreement with confirmed hCG quantitative level of tested specimens (at 20 mIU/ml cutoff) |
| Sensitivity | Not explicitly stated, but implied to detect elevated hCG levels at 20mIU/mL. | Detects elevated levels of hCG at the sensitivity of 20mIU/mL. |
| Ease of Use/Interpretation by Lay Users | "Easy to use and interpret result by the lay users." | Demonstrated to be "easy to use and interpret result by the lay users." and "clearly understood and accurately interpreted by laypersons at near-cutoff level concentrations." |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size:
- Main Accuracy (Consumer) Study: 148 lay users. The number of specimens isn't explicitly stated but would be at least 148 if each user tested one unique specimen. It is more likely that multiple users tested the same set of specimens.
- Additional Lay User (Near-cutoff) Study: 21 laypersons. Again, the number of specimens isn't explicitly stated, but each layperson tested the "dipstick" mode.
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Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they involved active participation by "lay users" performing tests and interpreting results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth for the test set was established through "confirmed hCG quantitative measurements." The document does not specify the number of experts involved in performing or interpreting these quantitative measurements, nor their specific qualifications (e.g., medical technologists, lab directors).
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for conflicting interpretations or results from the lay users. The "agreement" percentages are reported directly against the established ground truth (predicate device results or quantitative hCG levels). It implies a direct comparison rather than an adjudication process between multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as described in the provided text. The studies focused on direct performance and agreement of the device, primarily with lay users, against a predicate device and quantitative lab results. There is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of this device.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance was done in the sense that the device's ability to detect hCG was assessed independently (against quantitative hCG levels) by lay users following instructions. However, it's crucial to understand that this is a chemical immunoassay device, not an AI algorithm. Therefore, "algorithm only" performance, as typically understood in AI/software domains, does not apply here. The "device performance" is its standalone performance without a human-in-the-loop, though human users perform the physical testing and interpretation.
7. Type of Ground Truth Used
- The primary ground truth used was quantitative hCG measurements of the urine specimens. This is a definitive laboratory method for determining the presence and concentration of hCG.
- For the main accuracy study, the results of the predicate device (Teco Diagnostics One-Step Midstream Pregnancy Test) were also used as a comparative benchmark, implying that the predicate's results were considered a form of "ground truth" for comparison purposes.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as this is a chemical immunoassay device, not a machine learning or AI-based system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set, this question is not applicable.
§ 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.