Home 5 Clinical Diagnostic Insider 5 FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review

FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review

by | Jan 24, 2020 | Clinical Diagnostic Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review

On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review. Practical Impact: Effective Jan. 1, 2020, the newly exempted medical devices and test systems will no longer have to comply with the premarket clearance as long as certain conditions are met.

FDA 510(k) Medical Device Clearance

Under current FDA rules, new diagnostic tests are regulated like medical devices and thus need a premarket submission before they can be brought to market. Submission for low risk devices is generally via the 510(k) pathway which requires demonstrating that the device is at least as safe and effective as—aka, substantially equivalent to—an already legally marketed device that is not subject to premarket approval. Under the 2016 Cures Act, the FDA must publish lists identifying devices that no longer require clearance. The FDA had published such lists in 2017. The final order makes those lists final and incorporates them into the regulations.

Exempted Devices

More precisely, the FDA identified a list of class I devices and class II devices now exempt from premarket notification requirements, subject to certain limitations. The list includes over 200 class I and II devices ranging from clinical chemistry and toxicology tests to cardiovascular, dental, hearing, neurological, orthopaedic and radiology products. Among the exclusions are 37 clinical chemistry and clinical toxicology devices including:

  • Acid phosphatase (total or prostatic) test system;
  • Angiotensin converting enzyme (A.C.E.) test system;
  • Aspartate amino transferase (AST/SGOT) test system;
  • Glucose test system;
  • Continuous glucose monitor secondary display;
  • Iron (non-heme) test system;
  • Lactate dehydrogenase isoenzymes test system;
  • Methylmalonic acid (nonquantitative) test system;
  • Total thyroxine test system;
  • Uric acid test system; and
  • Breath-alcohol test system.

Also listed as being exempt are drug detection systems used for employment, insurance or federal drug testing programs, but only if they are used only for those purposes. Examples:

  • Amphetamine test systems;
  • Barbiturate test systems, benzodiazepine test systems;
  • Codeine test systems; and
  • Methamphetamine test systems.

The final order cautions that an exemption from the 510(k) process “does not mean that the device is exempt from any other statutory or regulatory requirements unless such exemption is explicitly provided by order or regulation.”


Medical device and diagnostic testing firms need to review the new exemptions lists to determine if any of their current or proposed products are now exempt, or if products for which a 510(k) application is pending are now exempt and within any exemption limitation.

New FDA Approvals

Key new product approvals announced from late December 2019 through mid-January 2020:


GeneoscopyBreakthrough device designation for colorectal cancer screening test based on extraction of stool-derived eukaryotic RNA transcripts
KDx DiagnosticsBreakthrough device designation for URO17 Bladder Cancer Recurrence Test
LuminexClearance for NxTag Respiratory Pathogen Panel qualitative test run on firm’s Magpix instrument to simultaneously detect and identify nucleic acids from multiple respiratory viruses and bacteria
MicrogenicsClearance for Cedia Benzodiazepine Assay, a homogeneous enzyme immunoassay to detect benzodiazepines in human urine at cutoff concentration of 200 ng/mL
Sentinel DiagnosticsClearance for Albumin BCP assay measuring albumin in human serum or plasma
i-SensClearance for ReliOn Premier Classic Blood Glucose Monitoring System measuring glucose in fresh capillary whole-blood samples drawn from fingertips, forearm, palm, thigh or calf
Promisemed Hangzhou MeditechClearance for Promisemed Heel Blood Lancet for collection of capillary blood from heels of newborn or premature babies
Immunotech Vit OburkaClearance for Active Free Testosterone RIA test radioimmunoassay used to measure free testosterone in human serum
Applied BioCode510(k) clearance for BioCode Respiratory Pathogen Panel (RPP) for use on BioCode MDx-3000 system
QiagenClearance for Therascreen PIK3CA RGQ PCR Kit as companion diagnostic to identify advanced breast cancer patients with PIK3CA mutations likely to respond to Novartis’ Piqray (alpelisib)
Applied BioCode510(k) clearance for BioCode respiratory pathogen panel diagnostic test used with firm’s MDx-3000 system for detecting common respiratory viruses and bacteria
AstraZeneca + MerckExpanded indication for olaparib (Lynparza) as a maintenance treatment for metastatic pancreatic cancer patients identified via a companion diagnostic
CuretisClearance for Unyvero LRT lower respiratory tract application cartridge
DiaSorin MolecularClearance for Simplexa VZV Swab Direct assay to detect varicella-zoster virus (VZV) DNA from cutaneous + mucocutaneous swab specimens
PerkinElmerDe novo premarket clearance for GSP Neonatal Creatine Kinase-MM kit for use in newborn screening for Duchenne Muscular Dystrophy

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