510(k) · Decided
DecidedAlbumin Cobalt Binding Test (Acb Test)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemia Technologies, Inc. · NJV Test, Albumin Cobalt Binding
Cleared on Feb 14, 2003 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 14, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- NJV
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023824 Albumin Cobalt Binding Test (Acb Test)Ischemia Technologies, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK053196 Ischemia Albumin Cobalt Binding Test (Acb Test)Inverness Medical Innovations, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K053196Ischemia Albumin Cobalt Binding Test (Acb Test)Inverness Medical Innovations, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023824 | Albumin Cobalt Binding Test (Acb Test) | Ischemia Technologies, Inc. | 2003 | — |
| +1 | K053196 | Ischemia Albumin Cobalt Binding Test (Acb Test) | Inverness Medical Innovations, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053196 | Ischemia Albumin Cobalt Binding Test (Acb Test) | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053196 (Inverness Medical Innovations, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NJV devicesNJV Test, Albumin Cobalt Binding: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJV
FDA has decided no NJV device since 2007.
Median 510(k) review, days · NJV
Too few NJV 510(k)s in any year since 2007 to give a median.
Recalls per year · NJV
No recall names NJV since 2007.
Adverse event reports per year · NJV
No MAUDE report names NJV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023824: Albumin Cobalt Binding Test (Acb Test).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023824
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026