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Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060619

by Diazyme Laboratories

Identifiers

510(k) Number
K060619 FDA 510(k)
FDA Product Code
KHS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1160 FDA 510(k)
Regulation Number
862.1160 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A, is an enzymatic assay device designed for the quantitative determination of carbon dioxide (CO₂) in serum and plasma. Classified as an enzymatic assay for carbon dioxide, it employs enzymatic reactions to measure CO₂ levels accurately, supporting clinical chemistry applications.

This kit is intended for in vitro diagnostic use only and includes a single-point calibrator alongside 0.9% saline as a zero reference. It generates a linear calibration graph for determining CO₂ concentrations in unknown samples. The device is supplied as a single-use assay kit and has received FDA 510(k) clearance under the classification of Class II (KHS product code). No additional regulatory markings or sterility assurances are specified.

Frequently asked questions

What clinical applications is the Diazyme Carbon Dioxide Enzymatic Assay Kit (Model KZ122A) primarily used for?

The kit is designed for quantitative determination of carbon dioxide (CO₂) levels in serum and plasma, supporting clinical chemistry applications. It uses enzymatic reactions to measure CO₂ accurately, which is useful for diagnosing and monitoring conditions related to acid-base balance, such as metabolic acidosis, respiratory disorders, or electrolyte imbalances.

Is this assay kit single-use, or can it be reused for multiple tests?

The Diazyme Carbon Dioxide Enzymatic Assay Kit (Model KZ122A) is explicitly supplied as a single-use assay kit. This means each kit is intended for one measurement cycle, ensuring accuracy and preventing cross-contamination between samples.

Does the kit include any calibration or reference materials, and how does it generate results?

Yes, the kit includes a single-point calibrator and 0.9% saline as a zero reference. These components allow users to create a linear calibration graph, enabling precise determination of CO₂ concentrations in unknown serum or plasma samples by comparing them to the calibrated scale.

What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

The kit received FDA 510(k) clearance under the Class II (KHS product code) designation, with a substantially equivalent decision. The review was conducted by the Clinical Chemistry (CH) Advisory Committee via a traditional clearance process, confirming its safety and performance for in vitro diagnostic use.

Are there any sterility assurances or special handling requirements for storage of this assay kit?

The provided data does not specify any sterility assurances for the Diazyme Carbon Dioxide Enzymatic Assay Kit (Model KZ122A). However, since it is intended for in vitro diagnostic use, standard laboratory practices—such as protecting from contamination, extreme temperatures, and moisture—should be followed. Always refer to the manufacturer’s instructions for storage guidelines.

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: Carbon Dioxide Enzymatic (CO2) Assay - Diazyme Laboratories, Diazyme Carbon Dioxide Enzymatic Assay Kit, Model Kz122a (K060619 ..., PDF K060619 - Diazyme Carbon Dioxide Enzymatic Assay Kit, Model Kz122a, DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diazyme Laboratories

Sources (1)

  • FDA 510(k) K060619 24 fields · synced Sep 20, 2026