IVD Devices Can Be Used Alone or in Combination with Other Devices
A) True - IVD devices can indeed be used alone or in combination with other devices.
Regulatory Framework Supporting Combined Use
The FDA's regulatory framework explicitly recognizes that IVD devices can function both independently and in combination with other diagnostic tools 1. The FDA defines IVDs as "those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions" - notably using the plural "systems" which inherently acknowledges multi-component configurations 1.
Evidence of Combination Use
Companion Diagnostics as Prime Examples
Companion diagnostics (CDx) represent the clearest regulatory example of IVDs designed specifically for combination use - these biomarker tests are explicitly designed to be used in conjunction with specific treatments 1. The FDA has approved over 20 companion diagnostics in oncology that work in combination with therapeutic agents 1.
Multi-Component IVD Systems
IVD Multivariate Index Assays (IVDMIA) combine multiple tests through algorithms - when software or algorithms generate a single result from multiple test results, these algorithms themselves are considered devices, creating a combination device system 1.
IVDs utilize a wide range of technologies and platforms that can be combined to detect and measure DNA, RNA, protein or other substances, with different platforms addressing different steps from sample collection through analyte detection and scoring 1.
Standalone Capability
IVDs are also clearly designed to function independently - traditional laboratory tests are typically marketed as complete kits with all necessary components to perform testing in CLIA-certified laboratories 1. These can be used as standalone diagnostic tools without requiring combination with other devices.
Clinical Practice Reality
In pathology departments specifically, the combined use of CE-certified IVDs, in-house IVDs, and research use only devices are described as "a cornerstone of diagnostics" and "crucial for optimal patient care" 2. This demonstrates that combination use is not just permitted but is standard clinical practice.