Roche Reagent for LDH

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K900121 ↗

FDA Product Code

CFJ

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

• Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

  Class II

  FDA 510(k) K952337 Active Cleared 9 Feb 1996

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

See all devices from Roche Diagnostic Systems, Inc. →

• What is the Roche LDH reagent used for?

  The Roche LDH reagent is designed to quantify the catalytic activity of lactate dehydrogenase (LDH, EC 1.1.1.27) in human serum and plasma. It enables precise enzymatic activity assessment, adhering to International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) standards. This is particularly useful in clinical chemistry for diagnosing and monitoring conditions affecting LDH levels, such as tissue damage, anemia, or liver disease.

• How is the Roche LDH reagent supplied and intended for use?

  The reagent is supplied as a lyophilized powder that requires reconstitution before use. It is intended exclusively for single-use in vitro diagnostic applications, meaning each vial is designed for one measurement cycle only. This ensures accuracy and prevents cross-contamination, aligning with standard practices for clinical chemistry reagents.

• Is the reagent compatible with specific clinical chemistry analyzers?

  Yes, the Roche LDH reagent is specifically designed for use with Roche COBAS INTEGRA automated clinical chemistry analyzers. Compatibility with these systems ensures optimal performance and integration into laboratory workflows, providing reliable LDH measurements for clinical decision-making.

• What storage conditions apply to the Roche LDH reagent?

  Storage conditions for the Roche LDH reagent are detailed in the accompanying method sheet, which is provided with the product. While the device data does not specify exact storage requirements, lyophilized reagents like this typically require protection from moisture, extreme temperatures, and light. Always refer to the method sheet for precise instructions to maintain reagent integrity and ensure accurate test results.

• Is sterility or MRI safety a concern for this reagent?

  The device data does not mention any sterility requirements or MRI safety considerations for the Roche LDH reagent. Since it is a lyophilized powder for in vitro diagnostic use, sterility is generally not a primary concern for the reagent itself, as it is not implanted or exposed to MRI environments. However, proper handling and storage practices should still be followed to avoid contamination.