510(k) · Cleared
Recalled · Class II · 2012Acs Digitoxin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · LFM Enzyme Immunoassay, Digitoxin
Cleared on Jul 14, 1997 after a 152-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Jul 14, 1997
- Review
- 152 days
- Class
- Class II
- Product code
- LFM
- Recalls
- 1
- 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 LFM? 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 |
|---|---|---|---|
| * | — | TDX Digitoxin Immunoassay 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2012 | Class II | Z-0510-2013 | Device Design | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LFM devicesLFM Enzyme Immunoassay, Digitoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFM
FDA has decided no LFM device since 2007.
Median 510(k) review, days · LFM
Too few LFM 510(k)s in any year since 2007 to give a median.
Recalls per year · LFM
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFM
18in 2025
MAUDE reports naming product code LFM, 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 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chiron Diagnostics ACS:180 Digitoxin Assay is for the quantitative determination of digitoxin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Routine monitoring of serum digitoxin concentrations is necessary to maintain therapeutic efficacy and avoid toxicity. Serum digitoxin levels combined with other clinical data provide the clinician with useful information to aid in adjusting patient dosage, achieving optimal therapeutic effect, and avoiding useless subtherapeutic or harmful toxic doses.
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/K970546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970546: Acs Digitoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970546
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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