# K990255: Dimension Drug Calibrator II, Model DC49B

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 16, 1999 after 20 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891093 (1989). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891093: Aca (R) Digitoxin Calibrator, E.I. Dupont DE Nemours & Co., Inc. (1989) Summary page 1.

## Most influential descendants
- K032574: Dimension Drug Calibrator II, Model DC49C (2003), 9 descendants of its own
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D (2004), 8 descendants of its own
- K160202: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (2016), 2 descendants of its own
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K222439: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (2023), 0 descendants of its own

## Indications for use
The Dimension ®Drug Calibrator 11 is an in vitro diagnostic product intended for the calibration of the following methods packages in Flex™ reagent cartridges: Acetominophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)

Source page: https://510kreport.com/device/K990255
Methodology: https://510kreport.com/methodology