Last synced on 6 December 2024 at 11:05 pm

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Page Type
Product Code
Definition
The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C).
Physical State
Liquid reagent
Technical Method
The reagent contains bispecific monoclonal antibodies which are directed against cell surface markers on selected white blood cells and glycophorin A on red blood cells. The reagent cross-links the selected white blood cells with the red blood cells, which increases the density of the selected cells. When a density gradient is applied during the blood cell extraction process, the selected white blood cells remain separated into the red blood cell layer away from the PBMC layer and non-selected cells, including T cells and antigen presenting cells contained in the PBMC layer.
Target Area
Whole blood samples
Review Panel
Microbiology
Submission Type
PMA
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

No Linked CFR Text

The FDA has not linked product code ORL 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.

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Page Type
Product Code
Definition
The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C).
Physical State
Liquid reagent
Technical Method
The reagent contains bispecific monoclonal antibodies which are directed against cell surface markers on selected white blood cells and glycophorin A on red blood cells. The reagent cross-links the selected white blood cells with the red blood cells, which increases the density of the selected cells. When a density gradient is applied during the blood cell extraction process, the selected white blood cells remain separated into the red blood cell layer away from the PBMC layer and non-selected cells, including T cells and antigen presenting cells contained in the PBMC layer.
Target Area
Whole blood samples
Review Panel
Microbiology
Submission Type
PMA
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

No Linked CFR Text

The FDA has not linked product code ORL 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.