An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with ß2-glycoprotein I (ß2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Device Description

The IgG Anti-AtherOx Test Kit 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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets those criteria:

The document provided does not contain explicit "acceptance criteria" for clinical performance in the typical sense of metrics like sensitivity, specificity, or agreement thresholds against an established reference standard. Instead, the clinical testing section focuses on demonstrating agreement with a legally marketed predicate device (REAADS IgG Anti-Cardiolipin Test Kit) across various patient populations. Therefore, the "acceptance criteria" are implied by the observed agreement rates with the predicate, rather than set a-priori.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (demonstrating substantial equivalence to a predicate device), the primary "acceptance criterion" appears to be sufficient agreement with the predicate device across different patient populations.

Performance Metric (Implied Acceptance)	Reported Device Performance
Agreement with Predicate Device (Overall)	90.2% (404/448)
Agreement for Healthy Controls
Positive Percent Agreement	N/A (0 cases)
Negative Percent Agreement	97.1% (95% CI = 94.8-99.4%)
Overall % Agreement	97% (95% CI = 94.8-99.4%)
Agreement for Rheumatoid Arthritis
Positive Percent Agreement	100% (1 case)
Negative Percent Agreement	82.7% (95% CI = 75.2-90.2%)
Overall % Agreement	82.8% (95% CI = 75.4-90.3%)
Agreement for Systemic Lupus Erythematosus (SLE)
Positive Percent Agreement	76.0% (95% CI = 59.3-92.7%)
Negative Percent Agreement	86.4% (80.3-92.6%)
Overall % Agreement	84.6% (95% CI = 78.7-90.5%)
Agreement for Secondary Anti-Phospholipid Syndrome
Positive Percent Agreement	73.9% (95% C1 = 56.0-91.9%)
Negative Percent Agreement	88.7% (95% CI = 81.4-96.1%)
Overall % Agreement	85.1% (95% CI = 77.9-92.3%)
Agreement for Pregnancy Morbidity (Subgroup)
Positive Percent Agreement	0% (0 cases)
Negative Percent Agreement	92.3% (77.8-100%)
Overall % Agreement	80.0% (95% CI = 59.8-100%)
Agreement for Arterial Thrombosis (Subgroup)
Positive Percent Agreement	78.6% (95% CI = 57.1-100%)
Negative Percent Agreement	96.4% (95% CI = 89.6-100%)
Overall % Agreement	90.5% (95% CI = 84.7-100%)
Agreement for Venous Thrombosis (Subgroup)
Positive Percent Agreement	85.7% (95% CI = 59.8-100%)
Negative Percent Agreement	80.0% (95% CI = 65.7-94.3%)
Overall % Agreement	81.1% (95% CI = 68.5-93.7%)

Study Information:

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: A total of 448 serum samples were tested:
  - 205 from healthy control patients.
  - 99 from patients with rheumatoid arthritis.
  - 143 from patients with systemic lupus erythematosus (SLE).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it uses "serum samples from" patients, implying they were collected prior to the study for testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not state that experts were used to establish a "ground truth" for the test set. Instead, the device's performance is compared to a legally marketed predicate device (REAADS IgG Anti-Cardiolipin Test Kit). The predicate device itself serves as the reference for comparison, not an independent expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There is no mention of an adjudication method in the context of expert review or ground truth establishment. The comparison is directly between the new device and the predicate device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is an in vitro diagnostic (IVD) device (ELISA test kit) for detecting antibodies in serum. It is not an AI-powered diagnostic imaging device or a device involving human readers/interpreters in the presented study. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is an IVD test kit. The "standalone" performance is essentially what is presented in the study: the direct comparison of the assay's results against the predicate device. There is no human-in-the-loop component in the interpretation of the test results described here beyond the laboratory technician performing the assay and reading the ODs.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or reference standard for comparison) in this 510(k) submission is the performance of the REAADS IgG Anti-Cardiolipin Test Kit, a legally marketed predicate device. The clinical diagnoses of the patients (healthy controls, RA, SLE, APS) serve as classification for the samples, but the direct comparison is test-vs-test.
The sample size for the training set:
- The document does not explicitly mention a "training set" for the purpose of machine learning or algorithm development. This is a traditional ELISA assay kit. The provided clinical study data (448 samples) represent the "test set" for performance evaluation, not a training set. Development and optimization of the assay would typically involve internal validation, but those details are not part of this summary in terms of a "training set" as understood in AI/ML contexts.
How the ground truth for the training set was established:
- As there's no mention of a "training set" in the context of algorithm development, this question is not applicable. The development of the assay itself would have involved establishing specific assay parameters, but the mechanism for doing so isn't detailed as "ground truth establishment" for a training set.

Summary

{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

{1}------------------------------------------------

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 coatedwith oxLDL/β2GPI complex (human), blocked andstabilized.
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/β2GPIantibodies (units) used to calculate control and patientresults
Controls:	Human sera with known normal and positive amounts ofIgG anti-oxLDL/β2GPI antibodies with designatedacceptable 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 withstabilizers and preservatives
Substrate:	One-component TMB chromogenic substrate containingtetramethylbenzidine and hydrogen peroxide
Stopping solution:	0.36 N sulfuric acid used to stop color development at theend of the assay
Wash solution:	33X concentrate wash buffer (PBS/Tween 20) (diluted to1 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).

{3}------------------------------------------------

F. Technological characteristics [§807.92(a)(6)]:

TechnologicalCharacteristic	Corgenix IgG Anti-AtherOxTest Kit	Predicate Device (REAADSIgG Anti-Cardiolipin Test Kit)
INTENDEDUSE	An enzyme-linked immuno-assay (ELISA) for the detectionof IgG antibodies to complexesformed by oxidized low-densitylipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) inindividuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipidsyndrome).	For the detection and semi-quantitation of anti-cardiolipinantibodies in individuals withsystemic lupus erythematosus(SLE) and lupus-like disorders(anti-phospholipid syndrome).
ANALYTE	Detection of IgG anti-phospholipid (anti-oxidizedLDL/β2GPI) antibodies inindividuals with autoimmunedisease	Detection of IgG anti-phospholipid (anti-cardiolipin)antibodies in individuals withautoimmune disease

Table V-1. Comparison of Technological Characteristics

Similarities
ASSAYPRINCIPLE	Indirect ELISA for detection ofIgG antibodies to phospholipidantigen	Same for predicate
SPECIMENTYPE	Serum	Same for predicate (or 3.2%sodium citrate plasma)
LEVEL OFSKILL	High complexity	Same for predicate
TECHNOLOGY	Binding of IgG antibodies insample to immobilizedphospholipid antigen followedby immunological detection	Same for predicate
Differences
INTERFERINGSUBSTANCES	Test not affected by hemoglobin,conjugated bilirubin, lipid orrheumatoid factor	No testing listed in PackageInsert

{4}------------------------------------------------

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 < 5 G units between the predicted and recovered values. A strongly-positive sample and a stripped serum pool were mixed at various fixed ratios to produce 11 evenly-spaced concentrations that were predicted to extend past the linear range of the assay. Evaluation of the data indicated that the linear range of the assay was 10 - 100 G units.

1. Precision
  The precision of the Corgenix IgG Anti-AtherOx Test Kit was assessed as specified in CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods. Serum samples with concentrations spanning the range of the assay were tested in the Corgenix laboratory by 2 operators in duplicate on each of 20 days over 30 calendar days. One reagent lot was tested, and assays were calibrated each day.

Sample	MeanConcentration(G Units)	Reproducibilityas %CV	Within-LaboratoryPrecision as %CV
Low	9.6	3%	13%
Med-Low	20.2	4%	12%
Med	28.1	7%	13%
Med-High	38.4	5%	12%
High	76.8	4%	10%

3. Limit of Blank (LOB)/Limit of Detection (LOD)

Limit of Blank and Limit of Detection were assessed according to CLSI Guideline EP17-A Protocols for Determination of Limits of Quantitation; Approved Guideline. The Limit of Blank (LoB) was defined nonparametrically.at the 95th percentile of the negative results at 6.1 G units. The Limit of Detection (LoD) was defined the lowest level where 5% or fewer of the observed measurements are below the LoB. Since none of the results for the positive data set were at 7.0 G units or below, so the LoD was set as 7 G units.

{5}------------------------------------------------

Interfering Substances

The materials in the following list were tested for their potential to interfere in measurements with the Anti-AtherOx Test Kit. The materials were added to five clinical samples with a range of IgG anti-oxLDL-B2GPI antibody concentrations up to the levels listed.

Hemoglobin	5 mg/mL
Triglycerides	30 mg/mL
Conjugated Bilirubin	0.2 mg/mL
Rheumatoid Factor	500 units/mL

Summary of clinical testing [§807.92(b)(2)]: H.

Serum samples from 205 control patients, 99 patients with rheumatoid arthritis and 143 patients with systemic lupus erythematosus were tested for elevated IgG antiphospholipid antibody levels using the Corgenix IgG anti-AtherOx and REAADS IgG anti-cardiolipin test kits (refer to Table X-3 below). Overall agreement between the two tests was 90.2% (404/448).

The positive/negative results were also compiled within the various disease groups using the cut-offs established for each kit. Refer to Tables V-4, V-5 and V-6 below.

Table V-3.

Assay Results Compilation For Samples From Healthy Controls

Healthy Controls	REAADS
	IgG Anti-Cardiolipin
	Pos	Neg
Corgenix	Pos	0	6
IgG Anti-AtherOx	Neg	0	199

Positive Percent Agreement = N/A Negative Percent Agreement = 97.1% (95% CI = 94.8 - 99.4%) Overall % Agreement = 97% (95% CI = 94.8 - 99.4%)

{6}------------------------------------------------

Table V-4. Assay Results Compilation For Samples From Patients With Rheumatoid Arthritis

Rheumatoid Arthritis	REAADSIgG Anti-Cardiolipin	Pos	Neg
CorgenixIgG Anti-AtherOx	Pos	1	17
	Neg	0	81

Positive Percent Agreement = 100% Negative Percent Agreement = 82.7% (95% CI = 75.2 - 90.2%) Overall % Agreement = 82.8% (95% CI = 75.4 - 90.3%)

Table V-5.

Assay Results Compilation For Samples From Patients With Systemic Lupus Erythematosus

SLE		REAADS
		IgG Anti-Cardiolipin
		Pos	Neg
Corgenix	Pos	19	16
IgG Anti-AtherOx	Neg	6	102

Positive Percent Agreement = 76.0% (95% CI = 59.3-92.7%) Negative Percent Agreement = 86.4% (80.3 - 92.6%) Overall % Agreement = 84.6% (95% CI = 78.7 - 90.5%)

Table V-6.

Assay Results Compilation From Patients With Anti-Phospholipid Syndrome Secondary to SLE

Secondary Anti-Phospholipid Syndrome		REAADSIgG Anti-Cardiolipin
		Pos	Neg
Corgenix	Pos	17	8
IgG Anti-AtherOx	Neg	6	63

Positive Percent Agreement = 73.9% (95% C1 = 56.0 - 91.9%) Negative Percent Agreement = 88.7% (95% CI = 81.4 - 96.1%) Overall % Agreement = 85.1% (95% CI = 77.9 - 92.3%)

{7}------------------------------------------------

To compare the performance of the two tests in more defined disease states, the results were separated by APS presentation symptom. These compilations are presented in Table V-7 (A, B, C).

Table V-7 A.

Compilation Of Assay Results Of Patients Who Had Experienced Pregnancy Morbidity

Pregnancy Morbidity	REAADSIgG Anti-Cardiolipin
	Pos	Neg
Corgenix Pos	0	1
IgG Anti-AtherOx Neg	2	12

Positive Percent Agreement = 0% Negative Percent Agreement = 92.3% (77.8 - 100%) Overall % Agreement = 80.0% (95% CI = 59.8 - 100%)

Table V-7 B.

Compilation Of Assay Results Of Patients With Arterial Thrombosis

Arterial Thrombosis	REAADS
	IgG Anti-Cardiolipin
	Pos	Neg
Corgenix	Pos	11	1
IgG Anti-AtherOx	Neg	3	27

Positive Percent Agreement = 78.6% (95% CI = 57.1 -100%) Negative Percent Agreement = 96.4% (95% CI = 89.6-100%) Overall % Agreement = 90.5% (95% CI = 84.7 - 100%)

Table V-7 C.

Compilation Of Assay Results Of Patients With Venous Thrombosis

Venous Thrombosis		REAADSIgG Anti-Cardiolipin
		Pos	Neg
Corgenix	Pos	6	6
IgG Anti-AtherOx	Neg	1	24

Positive Percent Agreement = 85.7% (95% CI = 59.8 - 100%) Negative Percent Agreement = 80.0% (95% CI = 65.7-94.3%) Overall % Agreement = 81.1% (95% CI = 68.5 - 93.7%)

{8}------------------------------------------------

I. Conclusions from the nonclinical / clinical testing {§807.92(b)(3)]:

The results of the above described studies demonstrate that Corgenix IgG Anti-AtherOx Test Kit is as safe and effective as the cleared predicate device.

: .

Additional Information [§807.92(d)]: J.

No additional information has been requested by the FDA at this time.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 4 2008

Corgenix, Inc. c/o Ms. Kimberly Hassler Director of Quality and Regulatory Affairs 11575 Main St. Suite 400 Broomfield, CO 80020

Re: K072032

Trade/Device Name: IgG Anti-AtherOx™ Test Kit (IgG antibodies to oxLDL/B2GPI complex) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: March 6, 2008 Received: March 7, 2008

Dear Ms. Hassler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to

{10}------------------------------------------------

Page 2 –

begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Peter R. Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Indications for Use Statement

510(k) Number:

K072032

Device Name:

IgG Anti-AtherOx Test Kit

IgG-Anti-AtherOx™ Test Kit (IgG antibodies to oxLDL/B2GPI complex)

Indications for Use:

Intended User:

The IgG anti-AtherOx™ test kit is intended for use primarily in clinical (hospital and reference) laboratories.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mana' mchan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaiuation and Sa

510(k) K072032

Regulation Number and 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).