Guidance for determining medical device application type: Application type for IVDDs

On this page

• Single medical device criteria
• Test kit criteria
• Medical device family criteria
• Medical device system for IVDDs criteria
• Additional examples

Single medical device criteria

A single medical device licence or authorization type should only ever contain 1 device.

Examples are:

• generic, open architecture, standalone analyzer
• single FISH Probe

The final medical device licence or authorization should only include 1 device ID and 1 device identifier. However, devices that vary in package sizes can be included under 1 application for a single medical device licence or authorization. In cases where there is one device with multiple packaging sizes, there would be 1 device ID and multiple device identifiers on the same licence or authorization.

Example:

• Glucose test strips that are sold in packages of 10, 50 and 100

Additional information

Medical devices, parts or components that cannot be assigned to a system, test kit, and a medical device family must be licensed or authorized individually. This includes components or parts that are not made by the manufacturer of the devices or systems with which they are connected.

Test kit criteria

In vitro diagnostic test kits can reside on the same test kit licence or authorization if they meet all of the following criteria:

• same intended use
• same test design
• same reagent formulation
  • differ only in size configuration or
  • only have minor differences in instrument-specific characteristics not likely to impact the performance of the test (for example, reagent volumes, number of tests, on-board stability of the reagent cartridge, cartridge design)
    • applies to test kits that only differ in the instrument platform they run on

As a general rule, a significant change to 1 test kit on a test kit licence or authorization with more than 1 test kit will impact all the test kits on that licence or authorization.

Examples:

• A rapid HIV test kit that comes in different size configurations (for example, a box of 25, 50 or 100 individual pouches, or just individual pouches).
• A manufacturer introduces the next generation of analyzer for use with their test kits. The only change to the test kits is the configuration of the assay cartridge. The test kit with the new configuration may be added to the existing test kit licence.
• Various formats (for example, midstream, test strip, cassette) of at-home pregnancy tests cannot reside on the same licence. Although all formats are indicated to determine human chorionic gonadotropin (hCG) levels in urine specimens, they do not all use the same test design.
• Three individual test kits that detect either IgA, IgG or IgM antibodies to the same virus cannot reside on the same test kit licence. Although they are associated with the same virus, each assay detects a different analyte (for instance, IgA, IgG or IgM). Safety and effectiveness of each assay are supported by different studies since they are not clinically equivalent. Therefore, each assay will require its own test kit licence.

All the reagents or articles of the test kit are sold under a single manufacturer's name.

The reagents or articles need not be sold as a complete package. Some reagents or articles may be sold separately due to a requirement for different shipping temperatures. Individual reagents can also be sold separately as replacement items for the kit. Each medical device that can be sold as a replacement item must have a unique device identifier and will be listed separately on the issued licence or authorization.

Test kits manufactured by the same manufacturer may include reagents that are compatible with other test kits.

Example:

• The ABC Diagnostic company manufactures a multi-analyte quality control that can be used with the ABC Diagnostic's test kit A and test kit B. The multi-analyte quality control can be listed on all test kit licences for which it is designed and labelled for use. This control will have a consistent device ID across all licences.

A test kit licence does not include any instrumentation needed to perform the test (for example, analyzers).

Additional information

If reagents or articles of the test kit (for example, controls, buffers) are available to the end user separately, their name and device identifier must be included on the licence or authorization application form. The test kit licence or authorization will include all the device identifiers.

Medical device family criteria

Medical device family members:

• are made by the same manufacturer
• may differ in size and/or concentration
  • for example, level 1, 2, 3 controls for Troponin are intended to be used with multiple Troponin assays from different manufacturers
• may have different brand names

Manufacturing processes, design and intended use must be the same between members of the family and supported by the same body of evidence.

Device family members

Examples:

• Blood glucose meters that share the same design and intended use but have different brand names.
• Blood glucose meters that share the same design and intended use but differ in features that do not affect the device's performance, such as wireless connectivity or data storage capacity.

Not device family members

Examples:

• Controls that have the same intended use but are composed of different analytes.
• A multiplex assay detecting Treponema pallidum (TP) and human immunodeficiency virus (HIV) and the corresponding single analyte tests (TP only and HIV only) cannot be considered family members.

For more information, consult:

• Medical device family criteria for non-IVDDs
• Guidance for the interpretation of significant change for a medical device

Analyzers may be listed on the same family application if they have the same design. They may differ in throughput, software, sample volume or performance characteristics (for example, sensitivity) for the compatible reagents.

Example:

• The Space EXL 200 analyzer is a modified version of the SPACE EXL analyzer. It is functionally identical to the SPACE EXL, except it does not have a Reagent Management System, which results in reduced on-board sample storage capacity. Both analyzers can be included on the same licence application type as a family.

Additional information

Under Section 30 of the Medical Devices Regulations (regulations), it is Health Canada's interpretation that each medical device must have its respective device identifier appear on the final licence in order to be licensed. Similarly, under section 68.08, it is Health Canada's interpretation that each medical device must have its respective device identifier appear on the final authorization in order to be authorized.

However, evidence of compliance to the regulations by only representative members of the medical device family is needed during the application review process.

Medical device system for IVDDs criteria

A medical device system includes a number of components or parts intended to be used together to fulfil the device's overall intended functions.

A medical device system should be represented and sold under a common "system" name. This could be a generic system name (for example, immunoassay system) or a trademarked/brand name (for example, ABC Immunoassay System). Health Canada strongly recommends that the system name appear on the medical device labelling.

The labelling should demonstrate how each component for the system is needed to fulfil the device's overall function. For example, an analyzer/meter and its corresponding test kit/panel/test strip that are dedicated exclusively to each other can be considered a system.

If an analyzer/meter is designed to support multiple different assays/panels/test strips provided by the same manufacturer, with the same brand name but with different intended uses, the assays/panels/test strips and the analyzer/meter should be licensed or authorized as test kits or single medical devices. The analyzer/meter should not be on a system licence or authorization with multiple assays/panels/test strips unless the intended use of the system is overarching and the results from the different assays/panels/test strips are used together to support the intended use.

Examples:

• TRUE GLU^TM Blood Glucose Monitoring System comprising TRUE GLU^TM test strips, TRUE GLU^TM controls and TRUE GLU^TM. All components are needed to work together to obtain a glucose reading. All components are all identified with the same brand name.
• The ABC analyzer is designed to be used with the ABC HCV. The analyzer and the assay work together to provide an HCV result. If the analyzer were designed so new and different assays could be added to the analyzer menu in the future, it would need to be licensed under a single device licence and the assays as separate test kit licences.
• A meter with 3 different test strips each measuring different analytes (for example, glucose, follicle stimulating hormone and vitamin B12) that do not need each other to fulfil each other's function. These cannot be considered a system even if they have the same brand name.
• A blood glucose monitoring system includes both glucose and ketone strips. The intended use for the monitor might be "an aid to monitor the effectiveness of diabetes control". The glucose and ketone strips may be licensed with the meter as a medical device system since they support the overarching intended use of the system.

There can only be 1 manufacturer for all system components. Components/parts of a medical device system that are labelled under a different manufacturer's name must be licensed or authorized separately.

An open architecture-type analyzer (an instrument that is manufactured with general-purpose features and is not intended for use with a specific test) is not considered a system component.

Systems manufactured by the same manufacturer may include components that are compatible with other systems.

Example:

• A wash buffer may be compatible with multiple different platforms/analyzers. In these instances, the cross-compatible system component should be listed on all system licences for which they are designed and labelled for use.

Additional information

As stated in Section 28 of the regulations, all the components of the system that are produced by the system manufacturer are deemed licensed when the system is licensed. Similarly, as stated in section 68.06, all the components of the system that are produced by the system manufacturer are deemed authorized when the system is authorized. For example, on-board reagents licensed as part of a system are deemed to have been licensed and can be sold with the system.

However, if the on-board reagents are meant to be sold separately as replacement reagents for the same system, then the medical device name and identifier must be included on the licence or authorization application form. The licence or authorization will include all the device identifiers.

Additional examples

Manufacturers may combine different IVD devices as listed in the following cases.

Blood grouping reagents, tissue typing/HLA typing reagents

Blood grouping reagents can be grouped under a family application by phenotype/group antigen, as long as they are the same type of reagent (for example, all monoclonal antibodies (human)).

Examples:

• Reagents for ABO determination (A₁, A₂, B, O, A₁B and A₂B phenotypes) may be bundled under 1 licence application and
• Kell phenotype reagents would be under a different application (K-k+, K+k-, K+k+, Kp (a+b-), Kp (a-b+) and Kp (a+b+) phenotypes)

The same approach may be applied to tissue typing/HLA typing reagents, which can be grouped by class specificities.

Example:

• Reagents used for Class I typing will require a family licence application while Class II reagents will require a separate family licence application.

Drugs of abuse panel tests

"Drugs of abuse" tests are used to obtain a drugs of abuse profile of the test sample based on the detection of a single drug or multiple drugs and metabolites in human urine. The configuration between these medical devices can vary in the number of drugs included and the format presentation (for example, cassettes vs. cups vs. strips).

These medical devices can be combined under one device licence or authorization application by format (for instance, an application for cups, an application for cassettes, an application for strips).

The device identifiers associated with a drugs of abuse test should include the product codes for the various drugs, rather than a device identifier specifying the number of drugs tests contained within a device. For example, device identifiers "AMP", "FEN" and "OXY" would represent amphetamine, fentanyl and oxycodone.

The final licence or authorization should include each drug's specific device identifier and the final product labelling would list all device identifiers (for instance, AMP FEN OXY) included in the respective medical device. The labelling for the test would still need to meet the requirements outlined in section 21(1) of the regulations.