(36 days)
The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism.
Quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
The provided document describes a 510(k) premarket notification for the "Sangui BioTech, Inc. INTACT-PTH [Parathyroid Hormone] ELISA" kit. This submission is for demonstrating substantial equivalence to a predicate device, not a de novo clearance requiring extensive clinical studies with specific acceptance criteria in the typical sense of a new medical device. The "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance | Comments |
|---|---|---|
| Primary Criterion: Correlation with Predicate Device | Correlation coefficient (R) of 0.99 with the Nichols Institute Diagnostics Allégro® Intact PTH (Parathyroid Hormone) kit. | This high correlation indicates excellent agreement between the proposed device and the predicate device. |
| Secondary Criteria: Regression Analysis | Slope of 0.997 and an intercept of 2.9 (compared to the predicate device). | A slope close to 1 and an intercept close to 0 indicate a very similar measurement scale and accuracy relative to the predicate. |
| Range of Measurement | Samples studied ranged from 3.2 to 805 pg/mL of intact PTH (as measured by the Nichols' kit). | Demonstrates performance across a wide clinical range. |
| Intended Use | Quantitative determination of Intact Parathyroid Hormone (PTH) in human serum, for differential diagnosis of hypercalcemia and hypocalcemia. | Matches the intended use of a legally marketed predicate device. |
| Technological Characteristics - Similarities | Two-site "sandwich" ELISA principle, polyclonal goat antibodies purified via affinity chromatography, immunometric assay principles, analytical sensitivity. | The proposed device shares fundamental technological bases with predicate devices (Nichols Allégro and DSL ACTIVE ™ I-PTH ELISA). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: One hundred and twenty-three (123) patient sera.
- Data Provenance: Not specified, but generally for 510(k) submissions, given the commercial nature of the companies involved (Sanqui BioTech, Nichols Institute Diagnostics, Diagnostic Systems Laboratories, Inc.), it is highly likely that the data was collected in a prospective manner for the purpose of this submission, or involved retrospective analysis of banked clinical samples. The country of origin is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable for a 510(k) submission where the goal is to demonstrate substantial equivalence to an existing device. "Ground truth" in this context is established by the predicate device's measurement, which is assumed to be the accepted standard. No independent experts are typically used to establish a separate "ground truth" for a comparative study like this. The predicate device itself serves as the reference.
4. Adjudication method for the test set
Not applicable. This was a direct comparison study between a new device and a predicate device, not a study requiring adjudication of expert interpretations. The "ground truth" was the measurement provided by the legally marketed predicate device.
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
Not applicable. This device is an in vitro diagnostic (IVD) kit for measuring a hormone, not an imaging device or an AI diagnostic tool that assists human readers. Therefore, an MRMC study and discussions of human reader improvement with AI are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is also not applicable. The device is a laboratory assay kit. Its "performance" is its ability to accurately measure PTH in a sample. The study demonstrated its performance by comparing its measurements to those of a predicate device. There is no "algorithm only" or "human-in-the-loop" concept in the traditional sense for this type of IVD kit; a human performs the assay according to instructions.
7. The type of ground truth used
The ground truth for the performance evaluation was the measurements obtained from the legally marketed predicate device (Nichols Institute Diagnostics Allégro® Intact PTH kit). The assumption in a 510(k) is that the predicate device provides accurate and clinically acceptable measurements.
8. The sample size for the training set
Not applicable. This is an immunoassay kit (ELISA), not a machine learning or AI model that requires a "training set." The development of the assay (e.g., antibody selection, optimize reagents) would involve internal R&D studies, but these are not referred to as "training sets" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device's development or the 510(k) submission for substantial equivalence.
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.