# K960377: Ena-C-T Total Cholesterol Test

- Pathway: 510(k) (Traditional)
- Applicant: Actimed Laboratories, Inc.
- Decided: May 2, 1996 after 97 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K981181: Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use) (1998), 0 descendants of its own

## Indications for use
The ActiMed ENA.C-T™ Total Cholesterol Test is a non-instrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is indicated for professional use in settings such as clinical laboratories and physician office laboratories (POLs) to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).

Source page: https://510kreport.com/device/K960377
Methodology: https://510kreport.com/methodology