(92 days)
The Instant-View Pregnancy Urine Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for laboratory and professional use only.
A single step, visually read, qualitative chromatographic immunoassay, single use strip test
The provide text describes the 510(k) summary for the Alfa Scientific Designs' Instant-View™ Pregnancy Urine Dip-Strip Test (K984079). It details the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims 100% agreement when compared to the predicate device and expected results. The acceptance criteria appear to be based on this 100% concordance.
| Acceptance Criterion | Reported Device Performance (Instant-View™ Pregnancy Urine Dip-Strip Test) |
|---|---|
| Accuracy by correlation with legally marketed test | 100% agreement for all results compared |
| Agreement with expected results in clinical lab and physician's offices | 100% agreement with expected results |
2. Sample Size Used for the Test Set and Data Provenance
- The document implies a comparison study ("correlation of the results") with a legally marketed device (OSOM Pregnancy Urine Test). The exact sample size for this comparison is not explicitly stated.
- It also mentions "evaluation results from clinical lab and three physician's offices." The sample size for these evaluations is not explicitly stated.
- The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, given it's an FDA submission, the clinical lab and physician's offices are likely in the USA. The studies appear to be prospective for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth for the comparison study involved a legally marketed device (OSOM Pregnancy Urine Test). The "expected results" were also used as a ground truth.
- The evaluation in clinical labs and physician's offices involved "persons with diverse educational backgrounds and working experience." The number of experts/readers is not explicitly stated, nor are their specific qualifications (e.g., "radiologist with 10 years of experience" is not applicable here as it's a diagnostic test interpreted by general healthcare professionals).
4. Adjudication Method for the Test Set
- The document states that the results "agreed 100% with the results expected" and showed "100% accuracy by correlation." This suggests that a formal adjudication method like "2+1" or "3+1" was not necessary or not explicitly detailed because there was perfect agreement. If discrepancies existed, an adjudication method would typically be described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- A formal MRMC study as commonly understood in medical imaging (comparing reader performance with and without AI assistance) was not performed or described. The study instead focused on the device's accuracy compared to a predicate and expected results. The "persons with diverse educational backgrounds and working experience" performing the evaluations in clinical labs and physician's offices suggest multiple readers, but it's not structured as a comparative effectiveness study with vs. without AI assistance as this device is a standalone diagnostic test, not an AI assisting human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The Instant-View™ Pregnancy Urine Dip-Strip Test is a qualitative immunoassay designed for visual interpretation. The tests described are effectively standalone performance evaluations of the device, as the human component is simply reading the presence or absence of lines, rather than an "algorithm only" in the AI sense. The entire system (strip + human reading) is the "standalone" device performance being assessed.
7. The Type of Ground Truth Used
- The ground truth relied on two main sources:
- Predicate device results: Comparison to the OSOM Pregnancy Urine Test (K953383).
- Expected results/Clinical laboratory standards: The evaluations from clinical labs and physician's offices were compared to "results expected," implying a reference standard or pre-determined truth, likely based on established laboratory methods for hCG detection.
8. The Sample Size for the Training Set
- This information is not provided. As this is a 510(k) submission for a lateral flow immunoassay, the "training set" concept (as it pertains to machine learning algorithms) isn't directly applicable in the same way. The device's design and manufacturing are based on established biochemical principles, not on training data.
9. How the Ground Truth for the Training Set was Established
- Again, this concept is not applicable in the context of this type of device. The "ground truth" for developing such a device would be the accuracy of the chemical reagents and the immunoassay design in detecting hCG at specific concentrations, which is inherent to its scientific development rather than established through training data in the ML sense.
§ 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.