# K071587: Ischemia Albumin Cobalt Binding Test (Acb Test) Assay

- Pathway: 510(k) (Special)
- Applicant: Inverness Medical Innovations, Inc.
- Decided: Jul 30, 2007 after 49 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) The Ischemia Albumin Cobalt Binding Test (ACB®Test) Assay Verification Set (AVS): named in the summary without a submission number

## Indications for use
The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation. For In Vitro Diagnostic Use

Source page: https://510kreport.com/device/K071587
Methodology: https://510kreport.com/methodology