(361 days)
The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only. The test kits are for health care professionals use including professionals at physician's office labs (POLs) and Point-of-Care site (POC).
The Fastep™ hCG Pregnancy Serum/Urine Test are distributed in Cassette format. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-B-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
Here's a breakdown of the acceptance criteria and study information for the Fastep™ hCG Pregnancy Serum/Urine Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= 95%"). Instead, it compares the device's performance to a predicate device (Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test) and declares "substantial equivalency." However, we can infer the performance metrics considered acceptable based on the reported results and the statement of substantial equivalency.
| Characteristic | Acceptance Criterion (Inferred from Predicate) | Reported Device Performance (Fastep™ hCG Test) |
|---|---|---|
| Accuracy (Urine Sample) | Substantially equivalent to Teco One-Step Combo Card Test (100% Sensitivity, 100% Specificity reported for predicate) | Sensitivity: 100.0% |
| Specificity: 100.0% | ||
| Accuracy (Serum Sample) | Substantially equivalent to Teco One-Step Combo Card Test (98.3% Sensitivity, 100% Specificity reported for predicate) | Sensitivity: 98.3% |
| Specificity: 100.0% | ||
| Analytical Sensitivity (Detection Limit) | Detects serum or urinary hCG at a concentration of 20 mIU/ml or greater. | Detects serum or urinary hCG at a concentration of 20 mIU/ml or greater. |
| Cross-reactivity (Specificity) | No cross-reaction with other hormones at specific levels (hLH, hFSH, hTSH, ß-core hCG) | No cross-reaction with hLH (300 mIU/ml), hFSH (1,000 mIU/ml), hTSH (1,000 μIU/mL), or ß-core hCG (up to 8.53 pmol/L). |
| Precision (at POL sites) | Consistent results across different lots, sites, and operators for negative, cutoff (20 mIU/ml), and various positive hCG concentrations. | At 20 mIU/ml: |
- Serum: 96.9% Positive, 3.1% Negative
- Urine: 96.9% Positive, 3.1% Negative
(100% agreement for negative and higher positive concentrations) |
| Interference | Performance not affected by specified pH, specific gravity, or presence of common substances (e.g., Acetaminophen, Albumin, Glucose). | Performance not affected by urine pH 3.0-8.5, specific gravity 1.00-1.03, or specified concentrations of 15 common substances. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 145 clinical specimen sets (referring to the combined urine and serum sets for accuracy correlation studies).
- Urine: 145 samples (59 positive, 86 negative)
- Serum: 145 samples (59 positive, 86 negative - derived from the 58 positive, 1 negative, 86 negative results)
- Data Provenance: Not explicitly stated as retrospective or prospective, nor is the country of origin specified beyond "clinical specimens." It's implied these are human clinical samples (urine and serum). The "POLs site study" suggests some data collected from Physician's Office Labs, which would be clinical settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The 510(k) summary does not specify the number of experts or their qualifications for establishing the ground truth.
4. Adjudication Method for the Test Set
- The 510(k) summary does not explicitly state an adjudication method. For the accuracy studies, the clinical serum specimens were "quantitatively confirmed by Abbott Architect i2000 instrument." This implies the Abbott Architect i2000 results served as the reference standard for the clinical specimens.
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. This device is a rapid chromatographic immunoassay, which is a point-of-care test, not an AI-powered diagnostic imaging or interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, effectively. This device is the standalone "algorithm" (biochemical reaction and visual interpretation) for detecting hCG. Its performance metrics (sensitivity, specificity, precision, cross-reactivity, interference) are all measures of its standalone capability to detect hCG in samples and provide a visual result. The "human-in-the-loop" aspect is the visual reading by a healthcare professional, but the performance data presented is for the device's ability to produce the correct positive/negative signal.
7. The Type of Ground Truth Used
- For the accuracy studies (clinical specimens): The ground truth for hCG concentration was established by quantitative confirmation using the Abbott Architect i2000 instrument (predicate device K093318). This is a well-established laboratory instrument for quantitative hCG measurement.
- For sensitivity, cross-reactivity, precision, and interference studies: The ground truth was established using known concentrations of hCG (e.g., 0 mIU/ml, 10 mIU/ml, 15 mIU/ml, 20 mIU/ml, 40 mIU/ml, 100 mIU/ml) and known concentrations of interfering substances, often in "spiked" samples. This represents a form of analytical gold standard or controlled experimental conditions.
8. The Sample Size for the Training Set
- This information is not provided in the 510(k) summary. For in vitro diagnostic (IVD) devices like this, the concept of a "training set" in the context of machine learning (where data is used to train an algorithm) is not directly applicable. The device's components (antibodies, reagents) are developed and optimized through R&D, and then validated with test sets.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the concept of a "training set" as commonly understood in AI/machine learning doesn't directly apply here. For the development and optimization of the test, the "ground truth" would have been established through well-characterized reference materials, known concentrations of hCG, and thorough analytical testing during the R&D phase to ensure the antibodies and test format functioned as intended. The 510(k) summary describes the validation testing, not the development process.
§ 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.