Flow-Pac LDH Reagent Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K823721 ↗

FDA Product Code

CFJ

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Flow-Pac Triglyceride Reagent

  Not classified

  FDA 510(k) K830957 Active Cleared 18 Apr 1983

• Bicarbonate Reagents Amresco Product #4326020

  Class II

  FDA 510(k) K904007 Active Cleared 13 Sep 1990

• Liquilyme Bun Reagent

  Class II

  FDA 510(k) K812945 Active Cleared 6 Nov 1981

• Amresco Subst Concen, Pro #2432, Buf, Nad, 2455, Tri

  Class II

  FDA 510(k) K852948 Active Cleared 7 Aug 1985

• Flow-Pac Albumin Reagent

  Class II

  FDA 510(k) K830536 Active Cleared 24 Mar 1983

• Creatinine Reagent Set

  Class II

  FDA 510(k) K832439 Active Cleared 17 Jan 1984

See all devices from Amresco, Inc. →

• What clinical setting or specialty is the Flow-Pac LDH Reagent Set primarily used in, and why is it relevant for that setting?

  The Flow-Pac LDH Reagent Set is designed for use in clinical chemistry settings, where it helps evaluate cellular damage by measuring lactate dehydrogenase (LDH) activity. LDH assays are critical for diagnosing conditions like tissue injury, hemolysis, or certain metabolic disorders, making it particularly relevant for labs focused on biochemical analysis and patient monitoring.

• Is the Flow-Pac LDH Reagent Set intended for single-use or repeated use, and what does that mean for workflow efficiency?

  The Flow-Pac LDH Reagent Set is explicitly labeled as a single-use diagnostic tool, meaning each set is designed for one-time use in automated clinical chemistry analyzers. This ensures consistency in test results and reduces the risk of contamination, though it may require clinicians to plan reagent usage carefully to maintain workflow efficiency.

• How should the Flow-Pac LDH Reagent Set be stored, and are there any special handling instructions beyond standard lab practices?

  Storage conditions for the Flow-Pac LDH Reagent Set are detailed in the manufacturer’s instructions, though the data does not specify exact requirements beyond what is provided in the packaging. Since it is a single-use diagnostic reagent, it should be stored in a way that preserves its integrity—typically at room temperature or refrigerated, away from direct light and moisture—until use. Always follow the included instructions to avoid compromising reagent stability.

• What type of analyzers is the Flow-Pac LDH Reagent Set compatible with, and how does this affect its usability in different lab environments?

  The Flow-Pac LDH Reagent Set is intended for use in automated clinical chemistry analyzers, though the exact compatible models are not listed in the provided data. Compatibility is likely specified in the accompanying instructions, so labs should verify their analyzer’s compatibility before use. This ensures accurate LDH measurements and seamless integration into existing workflows.

• What regulatory pathway was followed for the FDA clearance of the Flow-Pac LDH Reagent Set, and what does this mean for its safety and performance standards?

  The Flow-Pac LDH Reagent Set received FDA 510(k) clearance (K823721) under the Traditional pathway, with a classification of Substantially Equivalent (SESE) to a predicate device. This means its safety and performance were determined to be comparable to an existing, legally marketed device, ensuring it meets FDA standards for clinical chemistry reagents. The clearance also falls under product code CFJ, which pertains to diagnostic reagents.