510(k) · Cleared
ClearedEmit 2000 Gentamicin Assay and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · LCD Enzyme Immunoassay, Gentamicin
Cleared on Sep 4, 1996 as substantially equivalent to K904226 (Abbott Laboratories, 1990) after a 69-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Sep 4, 1996
- Review
- 69 days
- Class
- Class II
- Product code
- LCD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904226 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK904226 'Tdxflx AnalyzerAbbott Laboratories · 1990
- This deviceK962519 Emit 2000 Gentamicin Assay and CalibratorsBehring Diagnostics, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK042479 Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904226 | 'Tdxflx Analyzer | Abbott Laboratories | 1990 | — |
| 0 (this device) | K962519 | Emit 2000 Gentamicin Assay and Calibrators | Behring Diagnostics, Inc. | 1996 | — |
| +1 | K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr… | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 LCD? 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 LCD device
- #1 K243500 ARCHITECT iGentamicinscore 9.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K904226 | 'Tdxflx AnalyzerSummary page 1…nalysis of gentamicin in human serum or plasma. The modified Emit 2000 Gentamicin Assay has been found to be substantially equivalent to the Abbott TDx Gentamicin Assay (K904226) with regard to intended use, assay sample, and overall performance characteristics. I. PERFORMANCE STUDIES A. Within-Run and To… | 1990 |
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 |
|---|---|---|---|
| K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products… | 2005 | 0 |
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?
How does its category compare?
All LCD devicesLCD Enzyme Immunoassay, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCD
Too few LCD 510(k)s in any year since 2007 to give a median.
Recalls per year · LCD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCD
2in 2024
MAUDE reports naming product code LCD, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 3 |
| 2010 | 0 | — | 1 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.
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/K962519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962519: Emit 2000 Gentamicin Assay and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962519
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026