510(k) · Cleared
ClearedWiener Lab Colinesterasa AA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiener Laboratories Saic · DIH Colorimetry, Cholinesterase
Cleared on Feb 12, 2003 after a 72-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 12, 2003
- Review
- 72 days
- Class
- Class I
- Product code
- DIH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10) Named without a submission number |
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.
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 "Wiener lab. Colinesterasa AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human serum or plasma, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is…
Read the full statement (110 words)
The "Wiener lab. Colinesterasa AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human serum or plasma, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo Cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023992: Wiener Lab Colinesterasa AA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023992
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026