ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)

K053196 · Inverness Medical Innovations, Inc. · NJV · Dec 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K053196
• Device Name: ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
• Applicant: Inverness Medical Innovations, Inc.
• Product Code: NJV · Clinical Chemistry
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The Ischemia Albumin Cobalt Binding Test (ACB®) is 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 Syndrome (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 involves adding cobalt to a serum specimen; cobalt binds to the N-terminus of albumin in healthy individuals. In ischemic conditions, albumin's metal-binding capacity is reduced, leaving more free cobalt. Dithiothreitol (DTT) is added as a colorimetric indicator; free cobalt reacts with DTT to form a colored product. The degree of color formation is measured spectrophotometrically on clinical chemistry analyzers. The test is performed in a clinical laboratory setting by trained personnel. Results are used by physicians in conjunction with ECG and cardiac troponin to aid in the risk stratification of patients with chest pain. A negative IMA result helps rule out Acute Coronary Syndrome (ACS) in low-risk patients.

Clinical Evidence

No clinical data provided. Verification and validation testing performed on the additional clinical analyzers included calibration curve, linearity, sensitivity, precision, test method comparison, on-board component stability, specificity, and interfering substances.

Technological Characteristics

In vitro diagnostic colorimetric assay. Principle: Spectrophotometric detection of cobalt-DTT complex formation. Materials: Cobalt reagent, Dithiothreitol (DTT) indicator. Connectivity: Compatible with clinical chemistry analyzers. Software: Embedded in clinical analyzer systems for spectrophotometric data processing.

Indications for Use

Indicated for use as an aid in the evaluation of patients with suspected myocardial ischemia. Not for use as a stand-alone diagnostic test for acute coronary syndromes.

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.

Predicate Devices

• Albumin Cobalt Binding Test (ACB® Test) (K023834)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k053196

Ischemia Technologies, Inc. Albumin Cobalt Binding Test (ACB® Test)

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k023824
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was to expand the chemistry analyzers suitable for use with the ACB Test to include the Roche Cobas Integra® 700/800 analyzer with modified bilirubin interference information in the labeling.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.