Grouping medical devices as Fluorescence In Situ Hybridization (FISH) Probes IVDs

Reagents and accessories with the same product owner that fall under the same risk classification B or C, based on FISH methodology and within same FISH probes IVD Grouping Category

FISH probes IVD grouping requirements

You can group FISH probes in vitro diagnostic (IVD) reagents and their accessories and register them together, if they are:

  • From the same product owner
  • Of the same risk classification, either all Class B or all Class C
  • Based on fluorescence in situ hybridization (FISH) methodology
  • In the same category according to this table:
s/n FISH probes IVD grouping category

(closed list)

 Examples of gene targets

(non-exhaustive list)

1

Selective therapy
  • ALK gene
  • HER2

2

Pre-natal testing
  • Chromosomes 13,21,18, X and Y

3

Genetic testing of inheritable disease
  • ELN gene

4

Pathogen identification
  • Mycobacterium tuberculosis complex (MTC)
  • Escherichia coli

5

Hematologic disorder and blood cancer markers
  • Chromosomes 3, 7, 9 and 11

6

Other cancer markers
  • LAMP2 gene
  • Topoisomerase 2A gene
FISH probes IVD reagents grouped together using a specific FISH probes IVD reagents grouping, but are of different proprietary or brand names, will be listed separately on the SMDR.

Example

Manufacturer HSA Zen produces two products:

  1. HSA Zen ABC FISH Probes Kit (Selective Therapy)
  2. HSA Zen XYZ FISH Probes Kit (Selective Therapy)

Both products can be grouped under the Selective Therapy category and registered together in one application. Once approved, they will exist as two separate listings due to the difference in proprietary names.

Multiple usage categories

Reagents and their accessories intended for multiple uses across various categories may choose to group them as part of any one of the FISH probes IVD categories they qualify for.

Information to support the intended purposes of all the reagents and their accessories must be submitted as part of the product registration application.

Addition of new models

You can add new FISH probes to an existing FISH Probes IVD device listing if the new models:

  • Fulfil the same device-specific grouping criteria as the SMDR-listed devices
  • Have the same device proprietary name as the SMDR-listed devices

Please submit a Change Notification to make such additions.

A new product registration application has to be submitted for new devices with different proprietary names from those already registered.