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Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)

FDA UDI

Class II (US FDA UDI)

by Corgenix Medical Corporation

Identity

Trade Name
Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) FDA UDI
Generic Name
Oxidized low density lipoprotein-B2-glycoprotein I (OxLDL-B2GPI) complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
INTENDED USE An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only. SUMMARY AND EXPLANATION OF THE ASSAY The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability (thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such as SLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease (primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TEST This test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. FDA UDI
Model / Reference
11854 FDA UDI
Description
INTENDED USE An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only. SUMMARY AND EXPLANATION OF THE ASSAY The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability (thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such as SLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease (primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TEST This test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. FDA UDI

Identifiers

Catalog Number
11854 FDA UDI
Primary DI / UDI-DI
00855360006236 FDA UDI
510(k) Number
K072032 FDA UDI
FDA Product Code
MSV FDA UDI
GMDN Term
Oxidized low density lipoprotein-B2-glycoprotein I (OxLDL-B2GPI) complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corgenix Medical Corporation

Sources (1)

  • FDA UDI 2611afe2-115f-40d5-8020-415fffb22dc8 38 fields · synced May 31, 2026