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Reagent, Lactate Dehydrogenase (CFJ)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K760476

by Simmler & Son, Inc.

Identifiers

510(k) Number
K760476 FDA 510(k)
FDA Product Code
CFJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1440 FDA 510(k)
Regulation Number
862.1440 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a reagent for lactate dehydrogenase (LDH), classified under Nad Reduction/Nadh Oxidation. It is designed for use in clinical chemistry assays to measure lactate dehydrogenase activity in biological samples, aiding in the diagnosis and monitoring of conditions such as tissue damage, myocardial infarction, or liver disease.

The reagent is supplied as a single-use diagnostic reagent and is regulated under 21 CFR 862.1440 as a Class II device. It requires FDA 510(k) clearance (K760476) and is intended for use in clinical laboratories. Storage conditions and sterility are not specified in the regulatory data, but compliance with standard laboratory practices is implied for optimal performance.

Frequently asked questions

What clinical conditions is this lactate dehydrogenase reagent primarily used to diagnose or monitor?

This reagent is designed for clinical chemistry assays to measure lactate dehydrogenase (LDH) activity in biological samples. It aids in diagnosing and monitoring conditions like tissue damage, myocardial infarction (heart attack), or liver disease, where elevated LDH levels are clinically relevant.

Is this reagent intended for single-use or repeated use in a laboratory setting?

The reagent is explicitly labeled as a single-use diagnostic reagent, meaning each unit is intended for one assay cycle. Repeated use is not supported, as it could compromise accuracy or sterility.

What regulatory pathway was followed for FDA clearance of this lactate dehydrogenase reagent?

This reagent received FDA 510(k) clearance (K760476) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II device under 21 CFR 862.1440 and is intended for use in clinical laboratories.

Are there multiple sizes or models of this lactate dehydrogenase reagent, or is it supplied in a single formulation?

The provided data lists multiple registration numbers (e.g., 8040374, 3006716639, etc.), which may correspond to different lot formulations or batch identifiers rather than distinct physical sizes or models. However, no explicit size or model variations are described in the regulatory documentation.

What storage conditions should be followed for optimal performance of this reagent?

While the regulatory data does not specify exact storage conditions, standard laboratory practices for clinical chemistry reagents—such as refrigeration (typically 2–8°C) and protection from light—are implied to maintain stability and accuracy. Always refer to the manufacturer’s instructions for precise guidance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Reagent, Lactate Dehydrogenase 510 (k) FDA Premarket Notification ..., MULTICHEM LDH-L REAGENT (K872010) — FDA 510(k) | Innolitics, Simmler & Son, Inc. · DeviceClearance, Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Simmler & Son, Inc.

Sources (1)

  • FDA 510(k) K760476 24 fields · synced Sep 19, 2026