510(k) · Cleared
Recalled · 2005Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LCD Enzyme Immunoassay, Gentamicin
Cleared on Jan 6, 2005 as substantially equivalent to K962519 (Behring Diagnostics, Inc., 1996) and 1 other predicate after a 115-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Jan 6, 2005
- Review
- 115 days
- Class
- Class II
- Product code
- LCD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904226 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904226 | 'Tdxflx Analyzer | Abbott Laboratories | 1990 | — |
| −1 | K962519 | Emit 2000 Gentamicin Assay and Calibrators | Behring Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K962519 | Emit 2000 Gentamicin Assay and CalibratorsSummary page 3…and are substantially equivalent to the SYVA Emit 2000 Gentamicin Plus Assay and the SYVA Emit 2000 Gentamicin Plus Calibrators, which were cleared by FDA (K962519) for 1VD use. The relationship between the VITROS GENT assay and the predicate device, determined by least squares… | 1996 |
| * | K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12… Cleared while this submission was under review Summary page 4…in 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 gentamicin 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2005 | Not classified | Z-1460-05 | Other | Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
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?
For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS…
Read the full statement (107 words)
For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
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 GENT on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042479: Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042479
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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