510(k) · Cleared
ClearedCholinesterase Gen.2 Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DIH Colorimetry, Cholinesterase
Cleared on Jul 3, 2006 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) after a 75-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 3, 2006
- Review
- 75 days
- Class
- Class I
- Product code
- DIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951595 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- This deviceK061093 Cholinesterase Gen.2 Test SystemRoche Diagnostics Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| 0 (this device) | K061093 | Cholinesterase Gen.2 Test System | Roche Diagnostics Corp. | 2006 | — |
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 DIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 1…. Predicate The Cholinesterase Gen.2 test system is substantially equivalent to the devices currently marketed Cholinesterase Test System cleared under K95 1595. Device The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative Description determination… | 1995 |
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?
- Its one ancestor has a recall.
- 31 other devices also cite its predicate K951595.
How does its category compare?
All DIH devicesDIH Colorimetry, Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIH
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · DIH
Too few DIH 510(k)s in any year since 2007 to give a median.
Recalls per year · DIH
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIH
1in 2024
MAUDE reports naming product code DIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cholinesterase Gert.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in serum and plasma.
Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061093: Cholinesterase Gen.2 Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061093
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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