FDA Browser - Product Code - Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement (PMI)

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Page Type

Product Code

Definition

A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate.

Physical State

The device is a laboratory assay that consists of slide preparation materials, fluorescent FISH probes, buffers, nuclear counterstain, and a fluorescence-enabled microscope.

Technical Method

The assay uses fluorescence in situ hybridization, manual method, with a dual-labeled break-apart DNA probe. When the PDGFRB genetic locus is intact, a single yellow signal is visualized and when it is rearranged separate red and green signals may be visualized and enumerated under fluorescent microscopy.

Target Area

Human bone marrow aspirate or peripheral blood

Review Panel

Medical Genetics

Submission Type

HDE - Humanitarian Device Exemption

Device Classification

Class 3

GMP Exempt?

Summary Malfunction Reporting

Ineligible

Implanted Device

Life-Sustain/Support Device

Third Party Review

Not Third Party Eligible

MAUDE Alerts

View and Sign Up For MAUDE Alerts

No Linked CFR Text

The FDA has not linked product code PMI to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

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Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Page Type: Product Code
Definition: A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate.
Physical State: The device is a laboratory assay that consists of slide preparation materials, fluorescent FISH probes, buffers, nuclear counterstain, and a fluorescence-enabled microscope.
Technical Method: The assay uses fluorescence in situ hybridization, manual method, with a dual-labeled break-apart DNA probe. When the PDGFRB genetic locus is intact, a single yellow signal is visualized and when it is rearranged separate red and green signals may be visualized and enumerated under fluorescent microscopy.
Target Area: Human bone marrow aspirate or peripheral blood
Review Panel: Medical Genetics
Submission Type: HDE - Humanitarian Device Exemption
Device Classification: Class 3
GMP Exempt?: No
Summary Malfunction Reporting: Ineligible
Implanted Device: No
Life-Sustain/Support Device: No
Third Party Review: Not Third Party Eligible
MAUDE Alerts: View and Sign Up For MAUDE Alerts

No Linked CFR Text

The FDA has not linked product code PMI to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.