(293 days)
The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Quantitative determination of EPO [Erythropoietin] 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 text regarding the Sangui BioTech, Inc. EPO [Erythropoietin] ELISA kit:
The provided text is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, standalone clinical study for a novel device. Therefore, much of the information typically found in a detailed acceptance criteria and study report for a new device (like a machine learning model) is not explicitly present.
However, we can extract the relevant information and infer some aspects based on the context of a 510(k) submission for an in vitro diagnostic (IVD) device.
Acceptance Criteria and Study Details for Sangui BioTech, Inc. EPO ELISA Kit
Given the context of a 510(k) submission for an ELISA kit, the primary "acceptance criterion" is typically substantial equivalence to a legally marketed predicate device. This is often demonstrated through a correlation study comparing the performance of the new device to the predicate device using patient samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion (Inferred from 510(k) IVD norms) | Reported Device Performance (from text) |
|---|---|---|
| Correlation | High correlation (e.g., R ≥ 0.95 or similar for quantitative assays) between the proposed device and the predicate device results on patient samples. | Correlation coefficient (R) of 0.96 with a regression equation Y = 1.05X + 3.0. |
| Accuracy / Agreement | Close agreement between the measured values of the proposed and predicate devices. (Often implied by correlation and regression). | The regression equation (Y = 1.05X + 3.0) and high correlation suggest good agreement, where Y is the proposed device and X is the predicate. |
| Sensitivity | Analytical sensitivity sufficient for intended use. (While a difference is noted, it is documented in labeling). | Proposed device sensitivity: 2.0 mU/mL. Predicate device sensitivity: 0.7 mU/mL. The limitation of the proposed device's sensitivity is documented in the labeling. |
Important Note: The 510(k) summary explicitly lists "The data clearly demonstrates excellent correlation between the two devices" as the primary conclusion, fulfilling the requirement for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: One hundred twenty-six (126) patient sera samples.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, for a 510(k) for an IVD kit, these are typically clinical samples collected from a relevant patient population, likely from a local US population if the submission is for US market clearance. The samples studied ranged from 5 to 291 mU/mL of EPO as measured by the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not directly applicable in the context of this 510(k) submission for an ELISA kit comparison. The "ground truth" for the comparison study is the measurement obtained from the predicate device (Nichols Institute Diagnostics EPO Assay), which is an already legally marketed and accepted device. There are no human experts "establishing ground truth" by interpreting images or clinical data in this type of study.
4. Adjudication Method for the Test Set
- Not applicable. This is a quantitative assay comparison study, not an imaging-based diagnostic study requiring expert adjudication of reader interpretations.
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 (IVD) device (ELISA kit) and does not involve AI or human readers interpreting outputs in the way an imaging AI diagnostic might.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is an inherently standalone device as it is an laboratory assay kit. The performance described (correlation with the predicate) represents the performance of the device itself (the "algorithm" or assay chemistry) without human-in-the-loop performance in the sense of a clinical decision-making aid requiring interpretation.
7. The Type of Ground Truth Used
- The "ground truth" for this comparative study is the results obtained from the legally marketed predicate device (Nichols Institute Diagnostics EPO Assay). The study aimed to show that the new Sangui BioTech kit produced results that were statistically equivalent to those of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. ELISA kits, especially in this context, are not "trained" in the machine learning sense. The assay's parameters (e.g., antibody concentrations, incubation times) are developed through laboratory optimization processes, not by feeding data into a training algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" or "ground truth for training" in the machine learning sense for this type of device. The assay development involves standard biochemical and immunological optimization.
§ 864.7250 Erythropoietin assay.
(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”