# K061818: Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 18, 2006 after 20 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860021 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 2.
- (no number) VITROS Chemistry Products Calibrator Kit 3: named in the summary without a submission number

## Most influential descendants
- K122323: Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (Alpi (2012), 0 descendants of its own
- K121907: Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase Calibrator (2012), 0 descendants of its own

## Recalls of this device
- Oct 10, 2012 · Class III · Z-0988-2013: Correlation slope bias and accuracy shift

## Indications for use
The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista' System.

Source page: https://510kreport.com/device/K061818
Methodology: https://510kreport.com/methodology