# K962126: Acs CKMB II Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jun 21, 1996 after 18 days
- Product code: JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 5 (0 Class I)
- 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) Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Recalls of this device
- Jul 24, 2018 · Class II · Z-0113-2019: A potential bias was identified with certain kits compared to the internal standards.
- Jul 24, 2018 · Class II · Z-0114-2019: A potential bias was identified with certain kits compared to the internal standards.
- Jul 24, 2018 · Class II · Z-0115-2019: A potential bias was identified with certain kits compared to the internal standards.
- Jul 24, 2018 · Class II · Z-0116-2019: A potential bias was identified with certain kits compared to the internal standards.
- Jul 24, 2018 · Class II · Z-0117-2019: A potential bias was identified with certain kits compared to the internal standards.

## Indications for use
The intended use of ACS CKMB i is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K962126
Methodology: https://510kreport.com/methodology