# K023824: Albumin Cobalt Binding Test (Acb Test)

- Pathway: 510(k) (Traditional)
- Applicant: Ischemia Technologies, Inc.
- Decided: Feb 14, 2003 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053196: Ischemia Albumin  Cobalt Binding Test (Acb Test) (2005), 0 descendants of its own

## 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 (I M T M) by measuring the cobalt binding capacity of albumin in human serum. I M is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratijkation 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.

Source page: https://510kreport.com/device/K023824
Methodology: https://510kreport.com/methodology