# K981181: Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)

- Pathway: 510(k) (Traditional)
- Applicant: Actimed Laboratories, Inc.
- Decided: Aug 3, 1998 after 124 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: 2 generations back to K905405 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960377: Ena-C-T Total Cholesterol Test, Actimed Laboratories, Inc. (1996) Summary page 1.
- K905405: Chemtrak Accumeter Cholesterol Test, Chemtrak, Inc. (1991) Summary page 1.

## 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 physician directed use (PDU) by the patient for screening and monitoring cholesterol. In a PDU monitoring application, the patient’s physician (or other medical professional under the direction of a physician) initially trains the patient to use the test properly and provides information on the proper interpretation of results and limitations of the test. With the physician directed indication for use, patients on cholesterol lowering therapy can test their own total cholesterol at home and provide the results to their physician or other healthcare organization which works with the physician to maintain compliance on the therapy. In a PDU screening application, a physician (or other medical professional under the direction of a physician) initially trains a group of individuals to use the test properly and provides information on the proper interpretation of results and limitations of the test. The physician directed use version of the ENA-C-T™ Total Cholesterol Test kits are then distributed to the group of individuals who can use the test at home and then communicate their results to the physician or healthcare organization.

Source page: https://510kreport.com/device/K981181
Methodology: https://510kreport.com/methodology