ALBUMIN COBALT BINDING TEST (ACB TEST)

K023824 · Ischemia Technologies, Inc. · NJV · Feb 14, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023824
• Device Name: ALBUMIN COBALT BINDING TEST (ACB TEST)
• Applicant: Ischemia Technologies, Inc.
• Product Code: NJV · Clinical Chemistry
• Decision Date: Feb 14, 2003
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The Albumin Cobalt Binding Test (ACB® Test) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin. Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndromes (ACS) in low risk patients.

Device Story

The ACB Test is an in vitro diagnostic assay for human serum; it measures the cobalt binding capacity of albumin to detect Ischemia Modified Albumin (IMA). The test is performed in a clinical laboratory setting. The assay quantifies the reduction in albumin's ability to bind cobalt, which occurs during ischemic events. Results are provided to clinicians to be used alongside ECG and cardiac troponin measurements for the short-term risk stratification of patients presenting with chest pain. A negative IMA result, in the context of non-diagnostic ECG and normal troponin, aids in ruling out Acute Coronary Syndrome (ACS) in low-risk patients. The device does not replace standard diagnostic tests; reliance on IMA results alone is discouraged due to potential for misleading clinical decisions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Quantitative in vitro diagnostic test; measures cobalt binding capacity of albumin in human serum to detect Ischemia Modified Albumin (IMA).

Indications for Use

Indicated for patients presenting with chest pain or equivalent symptoms suggestive of cardiac origin. Used as an aid to short-term risk stratification for Acute Coronary Syndromes (ACS) in conjunction with ECG and cardiac troponin. Contraindicated for use in patients with positive IMA levels, positive troponin levels combined with negative/non-diagnostic/positive ECG, or positive ECG combined with positive/normal troponin levels.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is an abstract image of an eagle. The eagle is made up of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Peter Crosby, Ischemia Technologies, Inc. President and Chief Executive Officer 4600 West 60" Avenue Denver, CO 80003

FEB 1 4 2003

Re: K023824

Trade/Device Name: Albumin Cobalt Binding Test (ACB® Test) Regulation Number: 862.1215 Regulation Name: Albumin Cobalt Binding Test Regulatory Class: Class 2 Product Code: NJV Dated: 15 November, 2002 Received: 18 November, 2003

Dear Mr. Crosby:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in patients with potential. Acute Coronary Syndrome (ACS) who have positive IMA levels; or positive troponin levels combined with negative, non-diagnostic, or positive ECG: or positive ECG combined with positive or normal troponin levels has not been established. IMA results do not correlate with disease risk in the event of a positive IMA. ECG, or troponin test result, therefore reliance on the IMA results alone could be misleading as either ruling in or ruling out ACS.

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## Page 2 - Mr. Peter Crosby

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

If you desire specific information about the application of other 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

&. Dutonan

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications for Use Statement

K023824 510(k) Number (if known):

Device Name: Albumin Cobalt Binding Test (ACB Test)

## Indications For Use:

The Albumin Cobalt Binding Test (ACB® Test) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndromes (ACS) in low risk patients.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of inical Laboratory Devices
510(k) Number K023824