510(k) · Cleared
ClearedTrinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LEH Radioimmunoassay, Vancomycin
Cleared on Apr 27, 2016 as substantially equivalent to K963267 (Dade Intl., Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it.
- Decided
- Apr 27, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- LEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K891093 (1989). 6 ancestors in all, the oldest K833379 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK891093 Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1989
- 3 generations backK990255 Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999
- 2 generations backK032574 Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003
- 1 generation backK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
- This deviceK160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK161954 Atellica Solution, Atellica A-LYTE Integrated Multisensor…Siemens Healthcare Diagnostics · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023 · cites it directly0descendants
- K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891093 | Aca (R) Digitoxin Calibrator | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| −3 | K990255 | Dimension Drug Calibrator II, Model DC49B | Dade Behring, Inc. | 1999 | — |
| −2 | K032574 | Dimension Drug Calibrator II, Model DC49C | Dade Behring, Inc. | 2003 | — |
| −1 | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug… | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +1 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +1 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica… | Siemens Healthcare Diagnostics | 2017 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K963267 | Vancomycin Flex Reagent CartridgeSummary page 4…l: Toxicology Toxicology Predicate Device: Vancomycin Flex Reagent Dimension Drug Calibrator II Cartridge (k963267) (k033809) Page 1 of 9 DEVICE DESCRIPTION… | 1996 |
| * | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Summary page 4…gy Toxicology Predicate Device: Vancomycin Flex Reagent Dimension Drug Calibrator II Cartridge (k963267) (k033809) Page 1 of 9 DEVICE DESCRIPTION TRINIDAD CH… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K222439 (Siemens Healthcare Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K963267.
How does its category compare?
All LEH devicesLEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Trinidad CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is intended for in vitro diagnostic use in the calibration of Vancomycin (Vanc) on the Trinidad CH System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160202: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160202
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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