FDA 510(k) Glossary · device type

IVD - In Vitro Diagnostic

IVD (In Vitro Diagnostic) is a medical device used to perform tests on biological samples - such as blood, urine, or tissue - outside the human body. IVDs are regulated by the FDA under the 510(k) pathway and are reviewed across five dedicated panels including Chemistry, Microbiology, Hematology, Immunology and Toxicology.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
27,357 IVD-related submissions across Chemistry, Microbiology, Immunology, Hematology and Toxicology panels in the dataset.

Definition

An In Vitro Diagnostic (IVD) is a medical device - including reagents, calibrators, control materials, kits, instruments, and software - intended to be used for the examination of specimens derived from the human body. The term "in vitro" (Latin: "in glass") distinguishes these tests from in vivo diagnostics performed inside the body.

Types of IVD Devices

  • Analyzers - automated laboratory instruments that process and analyze biological samples at high throughput.
  • Rapid test kits - point-of-care devices that deliver results within minutes at the bedside or clinic.
  • Reagents and calibrators - chemical substances used in analytical procedures.
  • AI-based diagnostic software - SaMD that interprets test results using machine learning algorithms.
  • Molecular diagnostic systems - PCR, next-generation sequencing, and other nucleic acid-based platforms.

FDA Regulatory Pathway

Most IVDs are regulated as Class II devices and cleared through the 510(k) premarket notification pathway. Manufacturers must demonstrate substantial equivalence to a legally marketed predicate device. The FDA's Center for Devices and Radiological Health (CDRH) oversees most IVDs; some IVDs for blood banking and infectious disease are overseen by CBER.

IVD Panels in the Dataset

PanelSubmissionsAvg Review (days)
Chemistry13,22188
Microbiology7,038100
Immunology3,781104
Hematology3,291112
Toxicology3,02686

FDA References

Related Terms

SaMD - 510(k) Premarket Notification - Substantial Equivalence - Review Panel

Frequently Asked Questions

An In Vitro Diagnostic (IVD) is a medical device that performs tests on samples taken from the human body - such as blood, urine, saliva or tissue - outside the body (in vitro). IVDs include test kits, reagents, analyzers, and software used to diagnose disease, monitor conditions, or guide treatment decisions.

Most IVDs are Class II medical devices regulated through the FDA 510(k) premarket notification pathway. The manufacturer must demonstrate substantial equivalence to a predicate IVD device. IVDs are reviewed across five dedicated FDA panels: Chemistry, Microbiology, Hematology, Immunology, and Toxicology. Higher-risk IVDs may require Premarket Approval (PMA).

An IVD is defined by what it tests - biological samples outside the body. SaMD (Software as a Medical Device) is defined by its form - software performing medical functions without being part of a hardware device. AI-powered diagnostic software that analyzes lab results could qualify as both an IVD and SaMD simultaneously.

IVD submissions in the 510k Database dataset are distributed across five panels: Chemistry (13,221 submissions), Microbiology (7,038), Immunology (3,781), Hematology (3,291), and Toxicology (3,026). Chemistry is the fastest-clearing IVD panel at an average of 88 days.