# K061792: Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (LA) Flex Reagent Cartri

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Jul 18, 2006 after 22 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: 2 (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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904302: Dupont Dimension (R) Ethyl Alcohol (Alc) Method, E.I. Dupont DE Nemours & Co., Inc. (1990) Summary page 1.
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.
- K914508: Dimension (R) Lactic Acid Method, E.I. Dupont DE Nemours & Co., Inc. (1991) Summary page 2.
- K011033: Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132, Dade Behring, Inc. (2001) Summary page 2.

## Recalls of this device
- Jan 30, 2018 · Class II · Z-1540-2018: May produce erroneously low results from specific well sets.
- Aug 3, 2016 · Class II · Z-0039-2017: Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.

## Indications for use
The Dimension VistaTM Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. The Dimension VistaTM Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. The Dimension VistaTM Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The Dimension Vista TM Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). The Dimension VistaTm Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Source page: https://510kreport.com/device/K061792
Methodology: https://510kreport.com/methodology