Grouping medical devices as Immunohistochemistry (IHC) IVDs

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

IHC IVD grouping requirements

You can group IHC IVD reagents and their accessories and register them under one application, if they are:

  • From the same product owner
  • Of the same risk classification, either all Class B or all Class C
  • Based on IHC methodology
  • In the same grouping category according to this table:
IHC IVD grouping category

(closed list)

 Examples of analytes

(non-exhaustive list)

Selective therapy
  • HER2/neu
  • EGFR
Hematologic disorder and blood cancer markers
  • Immunoglobulin Kappa chain
  • Immunoglobulin Lambda chain
Other cancer markers
  • Alpha fetoprotein (AFP)
  • Cytokeratins
  • CD117
Pathogen markers
  • Escherichia coli
  • Candida albicans
  • Herpes simplex virus protein VP22
Immune disorders
  • Anti-nuclear antibodies (ANAs)
  • Anti-topoisomerase
  • Organ-specific autoantibodies
  • Anti-streptococcal hyaluronidase
  • Anti-streptokinase
  • Anti-streptolysin O
  • C-Reactive protein
Other pathology markers
  • P57
  • Growth hormone
IHC IVD reagents grouped together using a specific IHC IVD reagents grouping, but are of different proprietary or brand names, will be listed separately on the SMDR.

Note: IHC IVD grouping excludes reagents specifically intended to be used with flow cytometry.

Example 1

Manufacturer HSA Zen produces four IHC IVD products in one category, for immune disorders:

  1. HSA Zen ABC Antibody for immunological marker A
  2. HSA Zen ABC Antibody for immunological marker B
  3. HSA Zen XYZ Antibody for immunological marker C
  4. HSA Zen XYZ Antibody for immunological marker D

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

  1. HSA Zen ABC Immunohistochemistry Antibody (Immune Disorders)
  2. HSA Zen XYZ Immunohistochemistry Antibody (Immune Disorders)

Example 2

Manufacturer HSA produces four IHC IVD products in one category, for pathogen markers:

  1. HSA ABC Antibody Test Kit for pathogen marker A
  2. HSA ABC Antibody Test Kit for pathogen marker B
  3. HSA DEF Antibody Test Kit for pathogen marker C
  4. HSA ZEN Antibody Test Kit for pathogen marker D

All products can be grouped under the Pathogen Markers category and registered together in one application. Once approved, they will exist as three separate listings due to the difference in proprietary names:

  1. HSA ABC Immunohistochemistry Antibody Test Kit (Pathogen Markers)
  2. HSA DEF Immunohistochemistry Antibody Test Kit (Pathogen Markers)
  3. HSA ZEN Immunohistochemistry Antibody Test Kit (Pathogen Markers)

Reagents belonging to multiple IHC IVD categories

IHC reagents and their accessories intended for multiple uses across various categories may choose to group them as part of any one of the IHC 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 IHC IVD products to an existing IHC IVD device listing if the new models:

  • Fulfil the same device-specific grouping criteria
  • Have the same device proprietary name

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.