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Commercial Laboratory Tests and FDA Approval

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Three FDA Test Classifications

Putting Laboratory Tests into Practice: Part I II III IV V

Laboratory tests fall into one of three categories for FDA clearance and approval to market. They are categorized by intended use and by risk to determine the degree of review that is necessary to ensure that safety and effectiveness are met. As an example of intended use, a test used in conjunction with other laboratory or clinical methods to monitor for cancer recurrence could be Class II; the same test used by itself to diagnose or screen for cancer would likely be Class III.

  • Class I — Most of these tests are exempt from FDA review of submissions, although a manufacturer must still register with the agency, list the products in commercial distribution, and make those products according to Quality Systems Regulations (formerly, Good Manufacturing Practices). These devices present minimal potential for harm to the user and are often simpler in design than either Class II or Class III devices. They include common laboratory tests such as cholesterol, iron, and pregnancy tests, and most laboratory instrumentation. Class I devices are those that can be monitored by general controls. Some of the general controls that the FDA uses are: 1) the device must be registered with the FDA; 2) devices must be manufactured using Good Manufacturing Practices; 3) the labeling of the device must at least tell the user the product name, intended use, type of procedure it is, and - if it is an instrument - installation, operating, and maintenance procedures; and 4) the manufacturer must submit a 510(k) pre-market notification before marketing the device or test.
  • Class II — These tests often require pre-market notification under the 510(k) process in which the company submits data on analytical performance relative to a "predicate device" (a device already on the market for a similar intended use); clinical data are sometimes needed to support a manufacturer's intended use. This class includes assays such as toxoplasmosis tests, tests for drugs of abuse, and antinuclear antibody tests. Class II devices and tests are ones for which the general controls have not been deemed sufficient to ensure safety and effectiveness; therefore, they are subject to special controls such as special labeling, mandatory performance standards, and post-market monitoring. The majority of chemistry and hematology analytes, such as bilirubin, albumin, glucose, folic acid, and hematocrit, are Class II tests. Laboratory instruments, such as automated CBC devices, are in this class as well.
  • Class III — These tests require FDA approval that often involves agency review of clinical data. It is the most stringent category. This class includes tests for which there is not enough information about their safety and effectiveness to protect the public with just general or even special controls and/or tests that are of substantial importance in preventing impairment of human health. For example, hepatitis and cancer diagnostic tests are categorized as Class III.


Continue to the next article in the series: Part III: Laboratory-developed Tests (LDTs)


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