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Opticlone Igg1 Fitc/Igg1 Pe Isotypic Control

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953498

by Immunotech Corp.

Identifiers

510(k) Number
K953498 FDA 510(k)
FDA Product Code
GKZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5220 FDA 510(k)
Regulation Number
864.5220 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Opticlone IGG1 FITC/IGG1 PE Isotopic Control is a laboratory reagent classified as a Counter, Differential Cell device. It provides an isotopic control containing IgG1 antibodies conjugated with fluorescein isothiocyanate (FITC) and phycoerythrin (PE) for use in hematology flow‑cytometry assays.

The product was cleared through the FDA 510(k) pathway (K953498) as a Class II device with product code GKZ, decision date 1995‑09‑08 and clearance type Traditional. It is listed under regulation 864.5220 and is supplied by Immunotech Corp. in the United States.

Frequently asked questions

What is the intended use of the Opticlone IGG1 FITC/IGG1 PE Isotopic Control?

It is supplied as a laboratory reagent for hematology flow‑cytometry assays, serving as an isotopic control that contains IgG1 antibodies labeled with FITC and PE to verify instrument performance and staining consistency.

How is the product packaged and is it sterile?

The control is provided as a ready‑to‑use reagent in a sealed container designed for laboratory use. The data do not specify sterility, but as a flow‑cytometry control it is typically non‑sterile and intended for in‑vitro application only.

Is the Opticlone IGG1 FITC/IGG1 PE Isotopic Control single‑use or reusable?

The device is classified as a reagent and is generally intended for single‑use per assay to maintain accurate control conditions; reuse could compromise the fluorescence intensity and assay reliability.

What regulatory pathway was used for clearance and what does that imply?

It was cleared through the FDA 510(k) pathway (K953498) as a Class II device with product code GKZ, indicating it was found substantially equivalent to a legally marketed predicate and may be marketed in the United States under that clearance.

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: OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL 510(k) K953498 - fda.report, OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL 510 (k)… - FDA.report, OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunotech Corp.
FDA Applicant
Immunotech, Inc.

Sources (1)

  • FDA 510(k) K953498 24 fields · synced Sep 21, 2026