Kidney Test Waiver Shows How FDA Decides a Lab Test Is Simple Enough

The Food and Drug Administration on January 9 cleared Nova Biomedical's Allegro UACR assay, a cartridge test that measures albumin and creatinine in urine on the company's Allegro point-of-care analyzer, and in the same decision categorized it as a waived test. FDA's 510(k) database entry lists the clearance as K252206, received in July 2025 and found substantially equivalent on January 9. The agency's CLIA waiver decision summary, CW250009, describes it as a "Dual 510(k) and CLIA Waiver by Application" and concludes that the submitted information "supports a CLIA waiver approval decision."

A clearance says a test may be sold. The waiver decides where it can be run, and it rests on a separate law.

Three levels of test complexity

The Clinical Laboratory Improvement Amendments of 1988, known as CLIA, and their regulations at 42 CFR Part 493 require clinical laboratories to hold a certificate before they accept human samples, according to FDA's CLIA overview. The type of certificate, and the rules a lab must follow, depend on the complexity of the tests it runs. Three agencies share the work: the Centers for Medicare & Medicaid Services issues certificates, inspects labs and collects fees; FDA categorizes tests by complexity and reviews waiver applications; and the Centers for Disease Control and Prevention provides technical standards and research.

FDA sorts tests as waived, moderate complexity or high complexity. Tests cleared or approved for home use are automatically waived. Most others are categorized as moderate or high complexity after clearance, under criteria in 42 CFR 493.17, the agency's page on CLIA waiver by application says. A maker of a moderate-complexity test can then ask FDA to categorize it as waived, which lets sites with a Certificate of Waiver, such as many physician offices, perform it.

What a waiver application must show

The statute allows a waiver for tests that are "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result." FDA says an application should include a description showing the device is simple to use, a risk analysis of possible sources of error, evidence that failure alerts and fail-safe mechanisms work, "flex" studies showing the test holds up under stress and variations in use, a clinical study in the hands of intended users at intended sites, and simple labeling.

Nova's decision summary shows what that looks like. An untrained operator runs the test in three steps: transfer urine to the cartridge with a supplied capillary, run it on the analyzer, and read the result, with no reagent handling or calculation. The study was run in four physician offices, where 15 untrained operators with only a quick reference guide tested samples from 619 patients. The guide and the waived-user sections of the manual were written at no higher than a seventh-grade reading level, and the labeling must state that a Certificate of Waiver is required to run the test in a waived setting.

One submission or two

A company can file for a waiver after clearance, or file a dual submission that combines a complete 510(k) with the waiver application, as Nova did. FDA says a dual submission requires the 510(k) user fee and is subject to 510(k) refuse-to-accept rules, and that applicants should flag it in advance through a Pre-Submission. Under the device user fee agreement, FDA aims to reach a decision on a dual submission within 180 FDA days, or 320 if an advisory panel is needed. Possible outcomes include clearance with a waiver, clearance with the waiver denied, or neither. A stand-alone waiver application carries no user fee.

Once a waiver is granted, FDA adds the waived categorization to its public CLIA database at the next weekly update, the agency says.