510(k) · Cleared
Recalled · 2003TDXR Rea (TM) Ethanol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Jun 11, 1987 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 11, 1987
- Review
- 44 days
- Class
- Class II
- Product code
- DIC
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK871645 TDXR Rea (TM) EthanolAbbott Laboratories · 1987
- Descendant · cites it directly · 0 of its ownK972011 Opus EthanolBehring Diagnostics, Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K972011Opus EthanolBehring Diagnostics, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871645 | TDXR Rea (TM) Ethanol | Abbott Laboratories | 1987 | — |
| +1 | K972011 | Opus Ethanol | Behring Diagnostics, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIC? 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 DIC device
- #1 K250609 Sober Self-Testscore 10.3 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K972011 | Opus Ethanol | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2003 | Not classified | Z-0508-04 | Other | The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table |
| Nov 17, 2003 | Not classified | Z-0278-04 | Other | The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972011 (Behring Diagnostics, Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DIC devicesDIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DIC
Too few DIC 510(k)s in any year since 2007 to give a median.
Recalls per year · DIC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIC
3in 2025
MAUDE reports naming product code DIC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K871645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K871645: TDXR Rea (TM) Ethanol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871645
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026