(406 days)
The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies.
BP means Bullous pemphigoid. Bullous pemphigoid (BP) is a chronic blistering of the skin. It ranges from mildly itchy welts to severe blisters and infection, and may affect a small area of the body or be widespread. The vast majority of those affected are elderly, but it has been seen at all ages. It is an autoimmune disorder, meaning it is caused when the body's immune system malfunctions. The immune system is meant to defend the body against bacteria, viruses, and disease, but instead produces against healthy tissue, cells and organs. Some patients with BP have other autoimmune diseases such diabetes and rheumatoid arthritis. Various other factors have been reported to play a role in triggering BP. These include drugs (furosemide, penicillin's), mechanical trauma, and physical traumas (burns from radiation, sun or heat). The BP180 Elisa kit is designed to detect the BP180 protein. The related BP230 Elisa kit is designed to detect the autoantigen BP230, also known as bullous pemphigoid antigen.
This appears to be a 510(k) summary for an ELISA kit, which is a laboratory diagnostic device, not an AI/ML powered device. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, sample size for training set, etc.) are not applicable in the context of this traditional in-vitro diagnostic device submission.
Based on the provided text, here's what can be extracted:
Acceptance Criteria and Device Performance for MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit
The provided 510(k) summary (K071961) focuses on establishing "substantial equivalence" to predicate devices, rather than defining specific quantitative performance acceptance criteria in the way a novel AI/ML device might. The core "acceptance criteria" here is that the device is "comparably safe and effective" and has "similar indications" to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Safety | Comparably safe to predicate devices | Results of clinical and nonclinical testing indicate safety comparable to predicates. |
| Effectiveness | Comparably effective to predicate devices | Results of clinical and nonclinical testing indicate effectiveness comparable to predicates. |
| Indications for Use | Similar indications as predicate devices | "The MESACUP BP180 or BP230 TEST is a semiquantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings." This is deemed similar to the predicates' indications for detecting anti-skin antibodies in human serum for diagnosis of skin diseases, specifically bullous pemphigoid. |
| Technology | Capable of detecting target antibodies as effectively as predicate devices (using a different technology) | Uses ELISA technology to detect Anti BP180 Antibodies and Anti BP230 Antibodies. The performance is considered "comparably effective" to predicate devices using Indirect Immunofluorescence. |
| Test Fluid | Works with human serum | Confirmed to work with human serum. |
| IVD Status | Intended for In Vitro Diagnostic Use | Confirmed as an In Vitro Diagnostic (IVD) device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods." However, specific sample sizes for clinical or nonclinical test sets are not provided in this 510(k) summary. The summary does not mention country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. For an ELISA kit, ground truth typically comes from a reference method or clinical diagnosis, but details about expert involvement are not included here.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not applicable and not done for this type of in-vitro diagnostic device (ELISA kit). MRMC studies are typically performed for imaging or other diagnostic devices where human readers interpret results. This is a laboratory test where the result is quantitative or semi-quantitative, not interpreted by human readers in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is an ELISA kit, not an algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable. The device itself is the "standalone" diagnostic tool.
7. The Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used. However, for a diagnostic test like this, the ground truth for clinical studies would typically be established based on:
- Clinical Diagnosis: Established by a physician based on the patient's symptoms, physical examination, and other laboratory/histopathological findings consistent with bullous pemphigoid.
- Reference Methods: Comparison to established "gold standard" or highly accepted diagnostic methods for detecting BP180 or BP230 antibodies (e.g., Western blot, immunofluorescence, or other validated assays).
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning or AI is not applicable here. This is a traditional ELISA diagnostic kit, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense, this question is not applicable.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).