510(k) · Cleared
Recalled · Class II · 2025Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 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. · LEH Radioimmunoassay, Vancomycin
Cleared on Feb 7, 2005 as substantially equivalent to K020692 (Dade Behring, Inc., 2002) and 2 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1988. It has been recalled 3 times.
- Decided
- Feb 7, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- LEH
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K881040 (1988). 6 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 | K881040 | Emit Vancomycin Assay | Syva Co. | 1988 | — |
| −1 | K020845 | Emit 2000 Vancomycin Calibrators | Dade Behring, Inc. | 2002 | — |
| 0 (this device) | K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 LEH? 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 LEH device
- #1 K222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH…score 7.0 · 5 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K020692 | Emit 2000 Vancomycin AssaySummary page 3…brator Kit 11 are substantially equivalent to the SYVA Emit 2000 Vancomycin Assay and the SYVA Emit 2000 Vancomycin Calibrators, which were cleared by FDA (K020692 and K020845) for 1VD use. The relationship between the VITROS VANC assay and the predicate device, determined by le… | 2002 |
| * | K020845 | Emit 2000 Vancomycin CalibratorsSummary page 3…1 are substantially equivalent to the SYVA Emit 2000 Vancomycin Assay and the SYVA Emit 2000 Vancomycin Calibrators, which were cleared by FDA (K020692 and K020845) for 1VD use. The relationship between the VITROS VANC assay and the predicate device, determined by least squares… | 2002 |
| * | 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 vancomycin 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 |
|---|---|---|---|---|
| Apr 24, 2025 | Class II | Z-1833-2025 | Storage | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test… |
| Feb 21, 2017 | Class II | Z-1887-2017 | Under Investigation by firm | Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date. |
| Oct 12, 2005 | Not classified | Z-0173-06 | Other | Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All LEH devicesLEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LEH
Too few LEH 510(k)s in any year since 2007 to give a median.
Recalls per year · LEH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEH
14in 2025
MAUDE reports naming product code LEH, 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 | — | 2 | 4 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 0 | 55 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 40 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 2 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 2 | 13 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is…
Read the full statement (114 words)
For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).
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 VANC on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043386: Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 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/K043386
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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