# K061020: Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: May 10, 2006 after 27 days
- Product code: CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- 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: 2 generations back to K864230 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861700: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.
- K962820: Carbamazepine Flex Reagent Cartridge, Dade Intl., Inc. (1996) Summary page 2.
- K862359: Meth./Cali./Intru. Check for the Dimension System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 2.
- K994115: Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge, Dade Behring, Inc. (2000) Summary page 2.

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1657-2018: Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely dep

## Indications for use
The Dimension VistaTM Albumin Flex® reagent cartridge (ALB) is a device intended to mreasure the albumin concentration in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The Dimension VistaTM Aspartate amino transferase (AST) Flex® reagent cartridge is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. The Dimension VistaTM Carbamazepine (CRBM) Flex® reagent cartridge is a device intended to measure carbamazepine, an anticonvulsant drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy. The Dimension VistaTM Alanine amino transferase (ALT) Flex® reagent cartridge is intended to measure the activity of the enzyme pyruvic transaminase (ALT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases. The Dimension VistaTM Total Iron-binding capacity (TIBC) Flex® reagent cartridge is intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Source page: https://510kreport.com/device/K061020
Methodology: https://510kreport.com/methodology