Dimension Vista CTNI Flex Reagent Cartridge

• • Terminated Z-1671-2018 FDA Class II ·initiated 2 Jan 2018

  Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

510(k) Number

K063756 ↗

FDA Product Code

MMI

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Apolipoprotein Control Serum Chd, Model Ouph

  Class I

  FDA 510(k) K993310 Active Cleared 30 Nov 1999

• Dade Tru-Liquid Cardiac Control

  Class I

  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

  FDA 510(k) K033487 Active Cleared 24 Dec 2003

• Behring Coagulation System, Model BCS

  Class II

  FDA 510(k) K002080 Active Cleared 16 Nov 2000

• Modification to N Protein Standard Sl

  Class II

  FDA 510(k) K012470 Active Cleared 28 Sep 2001

• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

See all devices from Dade Behring, Inc. →

• What is the Dimension Vista CTNI Flex Reagent Cartridge used for in clinical practice?

  The Dimension Vista CTNI Flex Reagent Cartridge is designed for the quantitative measurement of cardiac troponin I in human serum or plasma. Cardiac troponin I is a key biomarker used to diagnose myocardial infarction (heart attack), so this cartridge helps clinicians assess heart damage by providing rapid and precise results.

• Is the Dimension Vista CTNI Flex Reagent Cartridge intended for single-use or can it be reused?

  The cartridge is explicitly labeled as a single-use component. It is supplied sterile and ready-to-use, eliminating the need for additional sterilization between uses. Reuse is not recommended or supported by the manufacturer.

• What system does this reagent cartridge require for operation, and how is it supplied?

  The cartridge is designed exclusively for use with the Dimension Vista integrated chemistry system. It is supplied as a sterile, ready-to-use component, meaning no further preparation is needed before insertion into the system.

• How should the Dimension Vista CTNI Flex Reagent Cartridge be stored, and what documentation covers its shelf life?

  Storage conditions and shelf life details are not explicitly listed in the provided data, but the manufacturer’s accompanying documentation (likely included with the product) specifies these requirements. Always refer to the official instructions for proper storage to maintain accuracy and reliability.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The cartridge received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent (SESE). It falls under FDA product code MMI (Immunoassay Method, Troponin Subunit) and adheres to Class II regulatory standards, as indicated in the submission records.