510(k) · Cleared
ClearedEna-C-T Total Cholesterol Test
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 May 2, 1996 as substantially equivalent to K905405 (Chemtrak, Inc., 1991) after a 97-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- May 2, 1996
- Review
- 97 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905405 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK905405 Chemtrak Accumeter Cholesterol TestChemtrak, Inc. · 1991
- This deviceK960377 Ena-C-T Total Cholesterol TestActimed Laboratories, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK981181 Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)Actimed Laboratories, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K981181Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)Actimed Laboratories, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905405 | Chemtrak Accumeter Cholesterol Test | Chemtrak, Inc. | 1991 | — |
| 0 (this device) | K960377 | Ena-C-T Total Cholesterol Test | Actimed Laboratories, Inc. | 1996 | — |
| +1 | K981181 | Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use) | Actimed Laboratories, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K905405 | Chemtrak Accumeter Cholesterol TestSummary page 1…Laboratories, Inc. 5 Terri Lane Burlington, NJ 08016 Classification Name Cholesterol (total) test system Predicate Device ChemTrak, Inc. AccuMeter® Cholestercl Test (K905405) MAY -2 1996 Submitter’s Name, Address, Telephone Number, Contact Person and Date Prepared o Intended Use and… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981181 | Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use) | 1998 | 0 |
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?
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 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).
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/K960377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960377: Ena-C-T Total Cholesterol Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960377
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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