DMI Blood Gas Analyzer/Cartridge

• • Terminated Z-1072-03 FDA Unclassified (pre-2012) ·initiated 14 Jul 2003 ·on shared 510(k) K924758

  An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K924758 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Diamond Medical, Inc. Model Dm 600

  Class I

  FDA 510(k) K874710 Active Cleared 8 Feb 1988

• Dmi Blod Gas Analyzer/Cartridge

  Class II

  FDA 510(k) K915087 Active Cleared 8 Jan 1992

• Diamond Medical, Inc., Model Dm 700

  Class I

  FDA 510(k) K863298 Active Cleared 17 Mar 1987

• Model Iso-2001 Univ. Patient Isolation Circuit

  Class I

  FDA 510(k) K875369 Active Cleared 5 Feb 1988

• Diamond Medical, Inc. Model Dm 800

  Class I

  FDA 510(k) K874709 Active Cleared 8 Feb 1988

• What clinical measurements does the DMI Blood Gas Cartridge support?

  The cartridge is designed for the DMI Blood Gas Analyzer to measure partial pressures of carbon dioxide (PCO₂) and oxygen (PO₂), as well as blood pH. These measurements are critical for assessing acid-base balance and respiratory function in patients, particularly in intensive care, emergency medicine, and laboratory settings.

• How is the DMI Blood Gas Cartridge supplied and prepared for use?

  Cartridges are supplied pre-packaged and ready for immediate use. No additional preparation is required beyond connecting the cartridge to the DMI Blood Gas Analyzer system. The packaging ensures sterility, and no further sterilization is needed.

• Is the DMI Blood Gas Cartridge intended for single-use or reusable?

  The cartridge is explicitly designed for single-use only. This design ensures accuracy, reliability, and compliance with clinical chemistry standards, eliminating the need for cleaning or reprocessing between uses.

• What regulatory pathway does the DMI Blood Gas Cartridge follow?

  The cartridge has received FDA 510(k) clearance (K924758) as substantially equivalent to predicate technology, confirming its compliance with U.S. regulatory standards. It is classified as a Class II medical device under FDA regulation 862.1120, specifically under the Clinical Chemistry advisory committee.

• Are there any specific storage conditions or MRI safety considerations for the DMI Blood Gas Cartridge?

  The regulatory data does not specify storage conditions or MRI safety for the cartridge. Users should follow manufacturer guidelines for optimal performance and safety, particularly regarding temperature, humidity, and protection from contamination.