510(k) · Cleared
ClearedVitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LDO Enzymatic Radiochemical Assay, Tobramycin
Cleared on Feb 7, 2005 as substantially equivalent to K003341 (Syva Co., Dade Behring, Inc., 2001) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Feb 7, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- LDO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K984288 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK984288 Vitros Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 1999 · Recalled
- 1 generation backK042476 Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- This deviceK043384 Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984288 | Vitros Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | 1999 | 3 |
| −1 | K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| 0 (this device) | K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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 LDO? 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? (2)
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 |
|---|---|---|---|
| * | K003341 | Emit 2000 Tobramycin Assay Emit 2000 Tobramycin CalibratorsSummary page 3…brator Kit 14 are substantially equivalent to the SYVA Emit 2000 Tobramycin Assay and the SYVA Emit 2000 Tobramycin Calibrators, which were cleared by FDA (K003341) for IVD use. The relationship between the VITROS TOBRA assay and the predicate device, determined by least square… | 2001 |
| * | K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12…Summary page 3…intended use, base matrix, storage and handling and instructions for use as the previously cleared VITROS Chemistry Products TDM Performance Verifiers (K042476). The labeling will be updated to add assigned values for tobramycin so that the TDM Performance Verifiers may be used with… | 2004 |
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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All LDO devicesLDO Enzymatic Radiochemical Assay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDO
FDA has decided no LDO device since 2007.
Median 510(k) review, days · LDO
Too few LDO 510(k)s in any year since 2007 to give a median.
Recalls per year · LDO
No recall names LDO since 2007.
Adverse event reports per year · LDO
2in 2022
MAUDE reports naming product code LDO, 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 | 1 |
| 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 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14…
Read the full statement (114 words)
For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA).
For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and TOBRA on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043384: Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043384
Report an extraction error
Are you the manufacturer?
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