Q&A column

In the context of class I devices and similar life science products, clinical laboratories should consider the following.

• If a clinical laboratory is using a class I device consistent with its CFR classification (and the device is not incorporated into an LDT), the lab may treat it similarly to an FDA-cleared or -approved device.
• If a clinical laboratory is using a class I device inconsistent with its CFR classification, the device should be treated as an LDT.
• If a clinical laboratory is using a life science product that is similar to the description of a class I device in the CFR, but the manufacturer has not registered and listed that product as a device with the FDA, it is technically not a class I device and would be considered an LDT.
• Assays developed by clinical laboratories that incorporate class I analyte-specific reagents are LDTs (see CAP checklist requirement COM.40850 LDT Reporting).
• Any LDT assay that incorporates a class I device is still considered to be an LDT.

Verification of test-performance specifications for class I devices that are not incorporated into LDTs should follow checklist requirement COM.40300 Verification of Test Performance Specifications—FDA-cleared/approved Tests. Clinical laboratory use of class I devices that are incorporated into LDTs, or use of similar life science products not registered/listed with the FDA, must follow checklist requirement COM.40350 Validation of Test Performance Specifications—Modified FDA-cleared/approved Tests and LDTs. These verification and validation requirements align with CLIA standards on establishing and verifying performance specifications.⁶ In practice, the regulatory and compliance burden on clinical laboratories is usually lower when using class I devices versus similar life science products.

1. Establishment Registration and Device Listing. U.S. Food and Drug Administration.
   www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
2. Devices@FDA. U.S. Food and Drug Administration. www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm
3. Refractometer for Clinical Use. 21 CFR §862.2800. www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-862/subpart-C/section-862.2800
4. Analysis and Responses to Public Comments. Fed Regist. 2023;68(16):3655. www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/FR-2003-01-24.pdf
5. General Controls for Medical Devices. U.S. Food and Drug Administration. www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
6. Standard: Establishment and Verification of Performance Specifications. 42 CFR §493.1253. www.ecfr.​gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR​c96​daead​380f6ed/section-493.1253

Jonathan Genzen, MD, PhD, MBA
Professor, Department of Pathology
University of Utah School of Medicine
Chief Medical Officer
ARUP Laboratories
Salt Lake City, Utah
Advisor, CAP Clinical Chemistry Committee

Colleen W. Robley, MLS(ASCP)
Quality and Regulatory Affairs
Senior Specialist
ARUP Laboratories
Salt Lake City, Utah

Maryam Salehi, PhD
Assistant Professor
Department of Pathology and Laboratory Medicine
Emory University/Grady Health System
Atlanta, Ga.

David M. Manthei, MD, PhD
Associate Professor
Department of Pathology
University of Michigan
Ann Arbor, Mich.
Chair, CAP Clinical Chemistry Committee