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K Number
K031208
Device Name
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
Manufacturer
CORGENIX, INC.
Date Cleared
2003-07-07

(81 days)

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

The REAADS IgM Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgG Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic test kits. It does not contain information about acceptance criteria or specific study details that prove the device meets acceptance criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices and thus can be marketed.

Therefore, I cannot provide the requested information based on the provided text.

§ 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).