# K961750: Document Cardiac Assayed Control

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Jul 22, 1996 after 77 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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) Dade CK-MB/Myoglobin Immunoassay Control Level 1,2 and 3: named in the summary without a submission number
- (no number) Abbott IMx STAT CK-MB Controls, L, M, H: named in the summary without a submission number
- (no number) Bio-Rad Unassayed Chemistry Control (Human) Levels 1 and 2: named in the summary without a submission number
- (no number) Beckman 1.D-Zone Liquid CK Isoenzyme Control: named in the summary without a submission number
- (no number) Beckman 1.D-Zone Normal LD Isoenzyme Liquid Control: named in the summary without a submission number

## Indications for use
This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.

Source page: https://510kreport.com/device/K961750
Methodology: https://510kreport.com/methodology