510(k) · Cleared
ClearedAcs Tobramycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · LCR Fluorescent Immunoassay, Tobramycin
Cleared on Feb 12, 1998 after a 112-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 12, 1998
- Review
- 112 days
- Class
- Class II
- Product code
- LCR
- 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 LCR? 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/FLx Tobramycin 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LCR devicesLCR Fluorescent Immunoassay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCR
FDA has decided no LCR device since 2007.
Median 510(k) review, days · LCR
Too few LCR 510(k)s in any year since 2007 to give a median.
Recalls per year · LCR
No recall names LCR since 2007.
Adverse event reports per year · LCR
1in 2024
MAUDE reports naming product code LCR, 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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 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 Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.
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/K974029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974029: Acs Tobramycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974029
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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