Search Results
Found 2 results
510(k) Data Aggregation
(24 days)
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM.
The Zeus Scientfic, Inc. MPO ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to myeloperoxidase in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to MPO. Elevated antibody levels to MPO may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "The Aptus (Automated) Application of the MPO ELISA Test System." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the acceptance criteria, reported device performance, details of a study proving the device meets criteria, sample sizes, expert qualifications, adjudication methods, or information about training sets.
Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory approval letter.
Ask a specific question about this device
(104 days)
MPO ELISA TEST SYSTEM
The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the provided text regarding the MPO EIA Test Kit, structured according to your request:
In this document summary, the "device" refers to the MPO EIA Test Kit. The "acceptance criteria" can be inferred from the performance characteristics reported, as these values are presented as demonstrating the device's acceptable function. The primary study described is a comparative analysis against IFA and an alternate ELISA, as well as a clinical sensitivity and specificity study.
Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity (vs. IFA) | High sensitivity for detecting ANCA | 95.0% (95% CI: 85.3% - 100%) |
| Relative Specificity (vs. IFA) | High specificity for ANCA | 100% (95% CI: 98.6% - 100%) |
| Relative Agreement (vs. IFA) | High agreement with IFA | 99.6% (95% CI: 98.7% - 100%) |
| Precision (Coefficient of Variation, C.V.) | C.V.'s of less than 15% | Intra-Assay: Ranges from 2.66% to 59.49% (Samples 1-9 across 3 assays). Most samples show C.V. |
Ask a specific question about this device
Page 1 of 1