(48 days)
The intended use of this product is the quantitative determination of Calcitonin in human serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
Quantitative determination of Calcitonin in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
Here's an analysis of the provided information to describe the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) submission for the Sangui BioTech, Inc. Calcitonin ELISA primarily relies on demonstrating substantial equivalence to a predicate device. The key acceptance criterion is a strong correlation between the new device and the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation (R value) with predicate device | R = 0.99 (with Scantibodies Calcitonin Assay) |
| Slope close to 1.0 | Slope = 0.940 |
| Intercept close to 0 | Intercept = 6.6 |
| Consistent measurement across relevant range | Samples ranged from 0.8 to 3,113 pg/mL (in predicate kit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Seventy-seven (77) patient sera.
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective comparison study as existing patient sera were analyzed using both devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" in the traditional sense for ground truth establishment. The ground truth here is the measurement obtained from the predicate device (Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay), which is considered the established standard. Therefore, no external experts were used to establish ground truth for this comparison.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of analytical results between two devices, not a scenario requiring adjudication of imaging interpretations or clinical outcomes. The predicate device's results served as the reference.
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 is an in vitro diagnostic device (ELISA kit) for quantitative determination of Calcitonin. It does not involve human readers interpreting images or clinical cases, nor does it involve AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is an inherent standalone performance study. The Calcitonin ELISA kit is a laboratory-based assay, and its performance is evaluated based on its own analytical results compared to a reference method, without human "in-the-loop" decision-making during the analytical process itself. The "algorithm" here is the biochemical reaction and measurement process of the ELISA kit.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used was the results obtained from a legally marketed predicate device, the Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay. This is often referred to as a "comparative ground truth" or "reference method" in analytical performance studies for in vitro diagnostic devices. Additionally, the document mentions another predicate, the Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay, uses the same antibodies and epitopes, further bolstering the claim of equivalence.
8. The Sample Size for the Training Set
Not explicitly stated, nor is a "training set" relevant in the context of this 510(k) submission. This is a comparison of a finished device's performance against a predicate, not a machine learning model requiring training. Any internal development or optimization of the Sangui BioTech ELISA kit would have occurred prior to this submission and would not be typically detailed as a "training set" in this manner.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this 510(k) submission for an ELISA kit comparison. The development of the ELISA kit itself would involve established chemical and biological principles and optimization processes, rather than ground truth labeling for a training set.
§ 862.1140 Calcitonin test system.
(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.