(32 days)
The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (IEMA) kit for the determination of prolactin (PRL) in human serum. The proprietary name is Prolactin (PRL) ELISA and the usual name is PRL IEMA. This device classification name is - prolactin test system - product code CFT (per 21 CRF section 862.1625). The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing monoclonal blotinylated anti-PRL antibody, the enzyme-labeled anti-PRL antibody and a serum containing the native antigen (PRL), reaction results between the native antigen (PRL) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (PRL) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.
The provided text describes the Monobind Inc. Prolactin (PRL) ELISA device and its substantial equivalence to a predicate device. It does not describe an AI medical device, but rather an immunoassay kit for measuring prolactin levels. Therefore, several of the requested categories for AI device studies are not applicable.
Here's the information extracted and organized as best as possible given the provided text:
Device Name: Prolactin (PRL) ELISA (Monobind Inc.)
Device Type: Enzyme immunoassay (IEMA) kit for the quantitative determination of prolactin (PRL) in human serum.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific threshold values. Instead, it describes performance characteristics and compares them to a predicate device to demonstrate substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate/Study Goal) | Reported Device Performance (Monobind ELISA) |
|---|---|---|
| Substantial Equivalence | Demonstration of similar technological characteristics and comparable clinical performance to the predicate device (Ciba Corning ACS 180). | Demonstrated through linear regression, recovery, and linearity studies. |
| Correlation Coefficient | Implied to be high, indicating good method agreement. | 0.973 (indicating good method agreement) |
| Linear Regression Equation | Implied to be close to y=x (slope ~1, intercept ~0). | y = 1.01(x) + 1.63 |
| Mean Value (Reference Method) | N/A (this is the predicate device's mean) | 17.3 ng/ml |
| Mean Value (New Device) | Expected to be close to the reference method. | 19.0 ng/ml |
| Recovery | Implied to be close to 100%. | Average 102.7% |
| Linearity | Implied to be close to 100%. | Average 96.7% |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 86 specimens
- Data Provenance: Not explicitly stated, but the specimens were sourced from "normal (including pregnancy) and disease states' populations." The country of origin is not mentioned. The study appears to be retrospective, using existing specimens for comparison against the predicate device.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is an immunoassay kit, not an image-based AI device requiring expert interpretation for ground truth. The "ground truth" for the test set was the measured PRL concentration as determined by the predicate device (Ciba Corning ACS 180 chemiluminescence test).
4. Adjudication Method
Not applicable. There was no adjudication method described as it's an immunoassay comparison study, not an expert panel review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, and no MRMC study was performed.
6. Standalone Performance (Algorithm Only)
Not applicable. This is an immunoassay kit, not an AI algorithm. The performance described is the standalone performance of the kit itself in comparison to a predicate device.
7. Type of Ground Truth Used
The ground truth for the comparison study was the prolactin (PRL) concentration as determined by the predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test.
8. Sample Size for Training Set
The document does not mention a separate "training set." The 86 specimens were used for the clinical comparison study to demonstrate substantial equivalence against the predicate device. For an immunoassay, the "training" equivalent would be the development and calibration of the assay itself, which is not detailed in terms of sample size for that specific process.
9. How Ground Truth for Training Set Was Established
Not applicable. As this is not an AI device, there isn't a "training set" in the sense of data used to train a model. The assay itself is based on established immunoassay principles and utilizes "several different serum references of known antigen values" to generate a dose-response curve for quantification. These "known antigen values" would have been established through prior reference methods, but the specifics are not detailed here.
§ 862.1625 Prolactin (lactogen) test system.
(a)
Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.