510(k) · Cleared
ClearedIschemia Albumin Cobalt Binding Test (Acb Test)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inverness Medical Innovations, Inc. · NJV Test, Albumin Cobalt Binding
Cleared on Dec 16, 2005 as substantially equivalent to K023824 (Ischemia Technologies, Inc., 2003) after a 30-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Dec 16, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- NJV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023824 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023824 Albumin Cobalt Binding Test (Acb Test)Ischemia Technologies, Inc. · 2003
- This deviceK053196 Ischemia Albumin Cobalt Binding Test (Acb Test)Inverness Medical Innovations, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023824 | Albumin Cobalt Binding Test (Acb Test) | Ischemia Technologies, Inc. | 2003 | — |
| 0 (this device) | K053196 | Ischemia Albumin Cobalt Binding Test (Acb Test) | Inverness Medical Innovations, Inc. | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023824 | Albumin Cobalt Binding Test (Acb Test) 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”. | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 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…
Read the full statement (190 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053196 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053196: Ischemia Albumin Cobalt Binding Test (Acb Test).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053196
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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