# K160202: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Apr 27, 2016 after 90 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K891093 (1989). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963267: Vancomycin Flex Reagent Cartridge, Dade Intl., Inc. (1996) Summary page 4.
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D, Dade Behring, Inc. (2004) Summary page 4.

## Most influential descendants
- K222439: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (2023), 0 descendants of its own
- K161954: Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K160202
Methodology: https://510kreport.com/methodology