510(k) · Cleared
ClearedEna-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actimed Laboratories, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Aug 3, 1998 as substantially equivalent to K960377 (Actimed Laboratories, Inc., 1996) and 1 other predicate after a 124-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 3, 1998
- Review
- 124 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905405 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905405 | Chemtrak Accumeter Cholesterol Test | Chemtrak, Inc. | 1991 | — |
| −1 | K960377 | Ena-C-T Total Cholesterol Test | Actimed Laboratories, Inc. | 1996 | — |
| 0 (this device) | K981181 | Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use) | Actimed Laboratories, Inc. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960377 | Ena-C-T Total Cholesterol TestSummary page 1…ri Lane Burlington, NJ 08016 Classification Name Cholesterol (total) test system Predicate Device ™~ ActiMed Laboratories, Inc., ENA-C-T™ Total Cholesterol Test (POL) (K960377) and ChemTrak AccuMeter® Cholesterol Test (K905405). Kq8 18! The ActiMed ENA-C-T™ Total Cholesterol Test is a no… | 1996 |
| * | K905405 | Chemtrak Accumeter Cholesterol TestSummary page 1…olesterol (total) test system Predicate Device ™~ ActiMed Laboratories, Inc., ENA-C-T™ Total Cholesterol Test (POL) (K960377) and ChemTrak AccuMeter® Cholesterol Test (K905405). Kq8 18! The ActiMed ENA-C-T™ Total Cholesterol Test is a non- instrumented, enzymatic assay intended for the i… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (204 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981181: Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981181
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026