(255 days)
No
The device description details a standard ELISA assay with spectrophotometric reading and log-log regression analysis for quantification, which are traditional laboratory techniques and do not involve AI or ML.
No
This device is an in vitro diagnostic (IVD) test designed to detect specific antibodies in patient samples, which aids in the diagnosis of diseases rather than providing therapy.
Yes
The device is an enzyme-linked immunoassay (ELISA) intended for the detection of specific antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders. The "Intended Use/Indications for Use" section explicitly states that it is for the "detection of IgG antibodies," which provides information about a patient's health status, directly fitting the definition of a diagnostic device.
No
The device is a test kit that involves chemical reactions and optical density measurements, which are hardware-based processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of IgG antibodies... in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome)." This indicates it's used to analyze a sample taken from the human body to provide information about a disease state.
- Device Description: The description details an "enzyme-linked immunoassay (ELISA)" which is a common laboratory technique used to measure substances in biological samples. It describes the process of using serum samples and reagents to detect antibodies.
- Intended User / Care Setting: It is intended for use in "clinical (hospital and reference) laboratories," which are settings where in vitro diagnostic tests are performed.
- Performance Studies: The performance studies involve testing "serum samples" from different patient groups, further confirming its use with biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for 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).
Product codes
MSV
Device Description
The proposed device is an indirect ELISA detecting IgG anti-oxLDL/B2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL-ß2GPI complex. Incubation allows the IgG anti-oxLDL-B2GPI antibody present in the samples to react with the immobilized antigen complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added forming complexes with the bound IgG anti-oxLDL-B2GPI antibody. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing 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-B2GPI antibody.
Results are obtained by reading the OD (optical density or absorbance) of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-B2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean ODs. Controls and patient results are determined from the calibration curve.
Components:
- Plate: 96-well polystyrene microtiter plate, 12 x 8 strips coated with oxLDL/β2GPI complex (human), blocked and stabilized.
- Sample diluent: PBS/protein-based solution (blue) to dilute patient, reference and controls prior to testing.
- Calibrators: Human sera with known values of IgG anti-oxDL/β2GPI antibodies (units) used to calculate control and patient results.
- Controls: Human sera with known normal and positive amounts of IgG anti-oxLDL/β2GPI antibodies with designated acceptable ranges in G units for quality control of results.
- Conjugate solution: PBS/protein-based solution (blue) containing HRP-conjugated goat polyclonal anti-human IgG antibody with stabilizers and preservatives.
- Substrate: One-component TMB chromogenic substrate containing tetramethylbenzidine and hydrogen peroxide.
- Stopping solution: 0.36 N sulfuric acid used to stop color development at the end of the assay.
- Wash solution: 33X concentrate wash buffer (PBS/Tween 20) (diluted to 1 liter of reagent grade water before use).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The IgG anti-AtherOx™ test kit is intended for use primarily in clinical (hospital and reference) laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performed studies include:
- Linearity: The linear range of the IgG anti-AtherOx Test Kit was based on protocols specified in CLSI Guideline EP6-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline" with an error goal of
§ 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).
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K072032
A. Safety and effectiveness information required per [§807.92(a)(1)]:
| Submitter's Name/Address | Contact Name/Information |
|---|---|
| Corgenix, Inc. | Daniel Simpson |
| 11575 Main Street, Suite 400 | Quality Assurance Manager |
| Broomfield CO 80020 | Phone: 303.457.4345 ext. 128 |
| Fax: 303.457.4519 | |
| Email: dfsimpson@corgenix.com |
Date Summary Revised:
March 31, 2008
Safety and effectiveness information required per [§807.92(a)(2)]: B.
| Device Proprietary Name: | IgG Anti-AtherOx | |
|---|---|---|
| Common Name: | Anti-Oxidized LDL Complex Antibody | |
| ELISA Test | ||
| Regulation Name: | Multiple autoantibodies immunological test system |
Classification No .: 21 CFR 866.5660 Product Code: MSV Review Panel: Immunology
ﺰ Identification of legally marketed device to which we are claiming equivalence {§807.92(a)(3)}:
Proposed Predicate Device Name(s); K Numbers; Manufacturers a.
REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative; K022992; Corgenix, Inc.
D. Description of device [8807.92(a)(4)]:
Summary and Explanation a.
The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability (thrombophilia) [1,2]. 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) [3]. APS is characterized by high titers of antiphospholipid antibodies with thromboembolic events of venous and arterial vasculatures, or with pregnancy morbidity (miscarriages and fetal loss). High titers of
Page 1 of 9
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antiphospholipid antibodies in secondary APS increase the risk of thrombosis by at least 2-fold [2]. In both primary and secondary APS, recurrence rates of thrombosis up to 30% and mortality up to 10% in 10 years have been reported [4,5].
Antiphospholipid antibodies are a heterogeneous family of immunoglobulins [6]. Most of these antibodies do not directly recognize phospholipids but instead recognize phospholipid-binding plasma proteins such as B2GPI and prothrombin. BoGPI is the most relevant antigenic target for antiphospholipid antibodies clinically associated with thrombosis [7,8]. B2GPI-dependent anticardiolipin (aCL) antibodies may be detected by ELISA tests using immobilized cardiolipin (CL) in the presence of B2GPI [9,10]. These antibodies also recognize ß2GPI immobilized on oxygenated microtiter plates but not when ß2GPI is immobilized on plain polystyrene plates [11]. These findings suggested that B2GPI-dependent aCL antibodies recognize an altered conformation of B2GPI when it is bound to negatively charged phospholipids.
Oxidative stress and oxLDL formation are common in patients with SLE and APS [12] suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). ß2GPI specifically binds to oxLDL [13,14]. OxLDL/B2GPI complexes have been characterized [15], demonstrated in patients with APS and SLE and implicated as pro-atherothrombotic autoantigens [16]. The physiologic relevance of IgG antibodies to oxLDL/B>GPI complexes was demonstrated in vitro by the enhanced macrophage uptake of IgG immune complexes containing oxLDL/B2GPI. The participation of macrophage Fcy receptors in the uptake of these complexes seems to be particularly important in the development of foam cells, atherosclerotic plaques and arterial thrombosis [13-15]. IgG anti-oxLDL/B2GPI antibodies in autoimmune patients may further accelerate the development of atherothrombosis [17,18].
Previously, IgG anti-oxLDL/B2GPI antibodies have been detected in SLE. systemic sclerosis (SSc) and rheumatoid arthritis (RA) patients. SLE and SSc patients had significantly higher anti-oxLDL/B>GPI antibody levels compared to healthy controls [18-20]. Also, in those studies RA patients had higher antibody levels than the controls but this difference was not statistically significant. IgG anti-oxLDL/B2GPI antibodies were significantly higher in SLE patient with APS compared to SLE controls without APS. Thus, the presence of circulating IgG anti-oxLDL/B2GPI antibodies seem to be etiologically important and a useful serologic marker for venous and arterial (atherothrombotic) risk in autoimmune patients [21-23].
b. Principle of the Test
This test is an indirect ELISA detecting IgG anti-oxLDL/B2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL-ß2GPI complex. Incubation allows the IgG anti-oxLDL-
2
B2GPI antibody present in the samples to react with the immobilized antigen complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added forming complexes with the bound IgG anti-oxLDL-B2GPI antibody. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing 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-B2GPI antibody.
Results are obtained by reading the OD (optical density or absorbance) of each well in a spectrophotometer. Calibrator sera are provided, with the IgG antioxLDL-B2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean ODs. Controls and patient results are determined from the calibration curve.
Device Description C.
| Plate: | 96-well polystyrene microtiter plate, 12 x 8 strips coated
with oxLDL/β2GPI complex (human), blocked and
stabilized. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample diluent: | PBS/protein-based solution (blue) to dilute patient,
reference and controls prior to testing |
| Calibrators: | Human sera with known values of IgG anti-oxDL/β2GPI
antibodies (units) used to calculate control and patient
results |
| Controls: | Human sera with known normal and positive amounts of
IgG anti-oxLDL/β2GPI antibodies with designated
acceptable ranges in G units for quality control of results |
| Conjugate solution: | PBS/protein-based solution (blue) containing HRP-
conjugated goat polyclonal anti-human IgG antibody with
stabilizers and preservatives |
| Substrate: | One-component TMB chromogenic substrate containing
tetramethylbenzidine and hydrogen peroxide |
| Stopping solution: | 0.36 N sulfuric acid used to stop color development at the
end of the assay |
| Wash solution: | 33X concentrate wash buffer (PBS/Tween 20) (diluted to
1 liter of reagent grade water before use) |
E. Intended use of device [§807.92(a)(5)]:
An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with B2glycoprotein I (B2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
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F. Technological characteristics [§807.92(a)(6)]:
| Technological
Characteristic | Corgenix IgG Anti-AtherOx
Test Kit | Predicate Device (REAADS
IgG Anti-Cardiolipin Test Kit) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED
USE | An enzyme-linked immuno-
assay (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 the detection and semi-
quantitation of anti-cardiolipin
antibodies in individuals with
systemic lupus erythematosus
(SLE) and lupus-like disorders
(anti-phospholipid syndrome). |
| ANALYTE | Detection of IgG anti-
phospholipid (anti-oxidized
LDL/β2GPI) antibodies in
individuals with autoimmune
disease | Detection of IgG anti-
phospholipid (anti-cardiolipin)
antibodies in individuals with
autoimmune disease |
Table V-1. Comparison of Technological Characteristics
| Similarities | ||
|---|---|---|
| ASSAY | ||
| PRINCIPLE | Indirect ELISA for detection of | |
| IgG antibodies to phospholipid | ||
| antigen | Same for predicate | |
| SPECIMEN | ||
| TYPE | Serum | Same for predicate (or 3.2% |
| sodium citrate plasma) | ||
| LEVEL OF | ||
| SKILL | High complexity | Same for predicate |
| TECHNOLOGY | Binding of IgG antibodies in | |
| sample to immobilized | ||
| phospholipid antigen followed | ||
| by immunological detection | Same for predicate | |
| Differences | ||
| INTERFERING | ||
| SUBSTANCES | Test not affected by hemoglobin, | |
| conjugated bilirubin, lipid or | ||
| rheumatoid factor | No testing listed in Package | |
| Insert |
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G. Summary of non - clinical testing [§807.92(b)(1)]
Analytical Sensitivity a.
Linearity 1.
The linear range of the IgG anti-AtherOx Test Kit was based on protocols specified in CLSI Guideline EP6-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline" with an error goal of