LogoFDA 510(k) Search
K Number
K971689
Device Name
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
1997-10-29

(175 days)

Product Code
MOB
Regulation Number
866.5660
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Euro-Diagnostica Immunoscan MPO-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Euro-Diagnostica Immunoscan Anti-Myeloperoxidase Antibodies (MPO-ANCA) Kit, stating its substantial equivalence to a predicate device.

While it mentions the "indications for use," it lacks specific details about:

  • Acceptance Criteria: What quantitative or qualitative metrics the device needed to meet.
  • Reported Device Performance: Actual sensitivity, specificity, accuracy, or other performance metrics from a study.
  • Study Design Details: Sample sizes, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, ground truth types, training set information, or how ground truth was established.

The document primarily confirms that the device is cleared for marketing based on its substantial equivalence to an existing device and specifies its intended use: "an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis."

To provide the information you requested, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, clinical study reports, or a performance evaluation section.

§ 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).