# K960378: Ena-C-T Assayed Total Cholesterol Controls

- Pathway: 510(k) (Traditional)
- Applicant: Actimed Laboratories, Inc.
- Decided: Apr 3, 1996 after 68 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
Longest line of descent: 1 generation back to K905405 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905405: Chemtrak Accumeter Cholesterol Test, Chemtrak, Inc. (1991) Summary page 1.

## Indications for use
ENA-C T™ Assayed Total Cholesterol Controls are intended for exclusive use with the ENA.C.T™ Total Cholesterol Test to monitor the performance of the test at the medical decision points in the determination of elevated cholesterol. The ENA.C-T™ Total Cholesterol Test is an instrument-free enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).

Source page: https://510kreport.com/device/K960378
Methodology: https://510kreport.com/methodology