# K053196: Ischemia Albumin  Cobalt Binding Test (Acb Test)

- Pathway: 510(k) (Special)
- Applicant: Inverness Medical Innovations, Inc.
- Decided: Dec 16, 2005 after 30 days
- Product code: NJV (Test, Albumin Cobalt Binding)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023824 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023824: Albumin Cobalt Binding Test (Acb Test), Ischemia Technologies, Inc. (2003). Our reading of the summary gave K023834, FDA’s number for HL888 (Health & Life Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Albumin Cobalt Binding Test (ACB®) Test”.

## Indications for use
The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMATM) 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. 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.

Source page: https://510kreport.com/device/K053196
Methodology: https://510kreport.com/methodology