510(k) · Cleared
ClearedImmage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob) Reagent / Beckman Drug Claibrator 3 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DNO Hemagglutination Inhibition, Gentamicin
Cleared on Feb 11, 1997 as substantially equivalent to K904226 (Abbott Laboratories, 1990) after a 127-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 11, 1997
- Review
- 127 days
- Class
- Class II
- Product code
- DNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904226 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK904226 'Tdxflx AnalyzerAbbott Laboratories · 1990
- This deviceK964009 Immage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob)…Beckman Instruments, Inc. · 1997
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) | K964009 | Immage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob) Reagent /… | Beckman Instruments, Inc. | 1997 | — |
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 DNO? 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 |
|---|---|---|---|
| * | K904226 | 'Tdxflx AnalyzerSummary page 1…ntamicin Test System (21 CFR §862.3450) Tobramycin Test System (21 CFR §862.3900) Calibrator (21 CFR §862.1150) Gentamicin (GEN) TDx®** Gentamicin Abbott* Laboratories, K904226 Reagent Reagent Inc. Tobramycin (TOB) TDx Tobramycin Abbott Laboratories, K904226 Reagent Reagent Inc. *Abbott Laboratories, Abb… | 1990 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K904226.
How does its category compare?
All DNO devicesDNO Hemagglutination Inhibition, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DNO
FDA has decided no DNO device since 2007.
Median 510(k) review, days · DNO
Too few DNO 510(k)s in any year since 2007 to give a median.
Recalls per year · DNO
No recall names DNO since 2007.
Adverse event reports per year · DNO
No MAUDE report names DNO since 2007.
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 | 0 |
| 2013 | 0 | — | 0 | 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Iimmunochemistry Systems and Beckman Drug…
Read the full statement (111 words)
The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Iimmunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay.
Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.
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/K964009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964009: Immage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob) Reagent / Beckman Drug Claibrator 3 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964009
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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