Raichem Ldh-P Reagent W/Separate Start-

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831419 ↗

FDA Product Code

CFJ

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Reagents Applications, Inc. →

• What clinical conditions is the Raichem LDH-P Reagent primarily used to evaluate through LDH testing?

  The Raichem LDH-P Reagent is designed for measuring lactate dehydrogenase (LDH) levels, which serve as a biomarker for tissue damage. It is particularly useful in assessing conditions involving cardiac, hepatic (liver), and muscular tissues, helping clinicians diagnose or monitor diseases like myocardial infarction, liver disease, or muscle disorders.

• Is the Raichem LDH-P Reagent intended for single-use or repeated use in a laboratory setting?

  The Raichem LDH-P Reagent is explicitly labeled as a single-use diagnostic tool for in vitro diagnostic (IVD) use. This means each vial is intended for one test cycle and should not be reused to maintain accuracy and prevent contamination.

• How is this reagent supplied, and what should I consider when handling it?

  The reagent is supplied as a diagnostic tool for clinical chemistry laboratories, but specific storage conditions or handling instructions are not detailed in the regulatory data. Since it is single-use and not described as sterile, proper laboratory protocols for reagent storage (e.g., refrigeration, protection from light) should be followed to preserve its integrity until use.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Raichem LDH-P Reagent received FDA clearance through a Traditional 510(k) pathway, classified as Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for in vitro diagnostic use in clinical chemistry laboratories.

• Are there multiple sizes or models of this reagent available, or is it a single formulation?

  The regulatory data does not specify distinct sizes or models for the Raichem LDH-P Reagent, implying it is likely supplied as a single formulation. However, the associated product codes (e.g., CFJ) and registration numbers suggest it may be listed under multiple lot or batch identifiers for inventory tracking, but not necessarily as varied formulations.