510(k) · Cleared
ClearedAdvia 1650 Cholinesterase Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · DIH Colorimetry, Cholinesterase
Cleared on Jan 18, 2002 as substantially equivalent to K913198 (Eastman Kodak Company, 1991) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jan 18, 2002
- Review
- 66 days
- Class
- Class I
- Product code
- DIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912217 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912217 Kodak Ektachem Clinical Chemistry SlidesEastman Kodak Company · 1991
- This deviceK013750 Advia 1650 Cholinesterase AssayBayer Diagnostics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912217 | Kodak Ektachem Clinical Chemistry Slides | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K013750 | Advia 1650 Cholinesterase Assay | Bayer Diagnostics Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 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? (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 |
|---|---|---|---|
| * | K913198 | Kodak Ektachem DT Slides (Che)Summary page 1…nd chronic hepatitis. 2. Predicate Device/ Method Product Name Reagent Part # | Calibrator Part # Predicate Device # Kodak Vitros 250/ Cholinesterase 800 4707 120 4247 K913198, K912217 3. Device / Method Product Name REF Calibrator Part # ADVIA 1650 / Cholinesterase B01-4605-01 N/A, (absolute calibrati… | 1991 |
| * | K912217 | Kodak Ektachem Clinical Chemistry SlidesSummary page 1…c hepatitis. 2. Predicate Device/ Method Product Name Reagent Part # | Calibrator Part # Predicate Device # Kodak Vitros 250/ Cholinesterase 800 4707 120 4247 K913198, K912217 3. Device / Method Product Name REF Calibrator Part # ADVIA 1650 / Cholinesterase B01-4605-01 N/A, (absolute calibration factor… | 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?
- None of the 2 ancestors has a 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 ADVIA 1650 Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase in human serum and plasma on the Bayer ADVIA 1650 system. Such measurement is used in the diagnosis and treatment of organophosphorus poisoning and of certain liver diseases such as cirrhosis and acute and chronic hepatitis.
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/K013750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013750: Advia 1650 Cholinesterase Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013750
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026