문서 작성일
수정일 2017년 09월 02일.

Part II in the series "Putting New Laboratory Tests into Practice"; this section deals with the types of tests that are manufactured and sold in bulk to hospital and reference laboratories, clinics, doctors’ offices and other healthcare facilities.

Accordion Title
수탁검사기관과 FDA 승인(Commercial Laboratory Tests and FDA Approval) - Part II
  • Overview

    This is the second in a series of articles that describe how different types of laboratory tests are developed, validated, and made available for use by patients and their health care providers. This section deals with the types of tests that are manufactured and sold in bulk to hospital and reference laboratories, clinics, doctors' offices and other health care facilities.

    Part I: Putting New Tests into Practice
    Part III: Laboratory-developed Tests (LDTs)
    Part IV: Exceptions: Humanitarian Use
    Part V: Tests Used in Clinical Trials
    Article Sources

     

    Commercial laboratory tests are those that are performed using commercially manufactured kits and equipment. The majority of lab tests in use today fall into this category. Unlike tests developed for use in a single laboratory or laboratory company (known as lab-developed tests), they are manufactured, marketed, and sold in volume as kits to multiple laboratories and other health care facilities. In the United States, the development and marketing of commercial tests are regulated by the US Food and Drug Administration (FDA). They are considered "medical devices" and, specifically, "in vitro diagnostic devices (IVD)." As such, they must be evaluated and approved by the FDA. Likewise, many countries around the world have agencies comparable to the FDA that are responsible for approving the use of clinical laboratory tests. Examples of commercial tests and tests systems that are often sold as kits to various laboratories include tests that detect and/or measure glucose, cholesterol, therapeutic drugs, tumor markers, and infectious diseases.

    The process required for a new commercial test to gain approval for marketing by the FDA can be long and costly, sometimes taking many years before the benefits are finally realized, depending on how complicated the test is. A number of ideas for tests never make it to the clinical trial stage, where the safety and efficacy are evaluated on patient volunteers, and sometimes a promising test that doctors read about in the scientific literature never becomes commercially available. If they do become available, other federal and state health agencies ensure that these laboratory tests meet stringent standards both during the manufacturing process and when they are used in the clinical laboratory. Just because a test performs well in the research laboratory doesn't mean that it will work in the daily operations of a clinical laboratory. Commercial tests don't always make it to market or get put into practice

  • FDA Classification

    FDA Classification and Requirements for Approval

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

    The FDA classifies medical devices, including laboratory tests, based on the level of control needed to assure that the device is safe and effective. Devices that support or sustain human life, present a potential or unreasonable risk of illness, or can greatly prevent human health from being impaired fall into FDA's most stringent category, Class III, and must demonstrate reasonable assurance of safety and effectiveness before being approved for marketing in the US. These are tests that are subject to the highest standards of proof of their safety and effectiveness and may require the most time and resources to gain approval. Examples of Class III devices in the laboratory are the tests used to diagnose cancer and those used to detect antibodies for the Hepatitis C virus, which, if untreated, can lead to chronic liver disease.

    By comparison, Class I devices pose little risk to human life and are generally not as complicated, so they are exempt from FDA review. A simple blood test to determine uric acid concentrations in serum uses a method that is well understood and has been in use for many years. It is relatively straightforward to monitor the quality of test results and to ensure that the test is performing to specifications. In addition, the test, which falls under the Class I category, provides supportive evidence to a doctor's preliminary diagnosis of gout, a nonfatal and generally treatable disorder.

    Besides assessing the potential risk to the patient, the other factor used to classify tests is the FDA's familiarity with the test process itself and the medical devices and equipment used to produce the result. Under the 1976 Safe Medical Device Act that established the FDA's regulation of medical devices and tests, manufacturers are required to notify the agency of their intent to market a new product. The FDA permits most Class I and II medical devices to be marketed after the manufacturer can demonstrate that the device is "substantially equivalent" or as safe and effective as a similar device already on the market.

    Devices or tests that have a new use or that pose new issues of safety and effectiveness generally require submission of a pre-market approval (PMA) application with valid findings from human clinical trials that demonstrate that the device is clinically effective for its intended use. In addition to reviewing and approving the clinical data from the company-sponsored trials, FDA also confirms that the device will be manufactured in conformance to good manufacturing practices.

    As an example of a PMA, in December 1998, the FDA granted approval to Vysis, Inc., a genomic disease management subsidiary of Abbott Laboratories, Abbott Park, IL, to market a testing kit that can detect amplification of the Her-2/neu gene from human breast cancer tissue specimens. Detection of multiple copies of this gene in patients is important since these patients tend to experience rapid tumor growth, resistance to therapy, and decreased survival rates. Detection of the gene can allow doctors and patients to choose the most beneficial form of treatment, according to the company.

    In addition to FDA approval, all commercial tests must be evaluated by individual laboratories before they are put into use. A lab must demonstrate that it can perform the test with the same accuracy and precision as specified by the manufacturer of the test. And commercial tests, once they have been put into practice, must be evaluated on a regular basis with in-house quality assurance programs to ensure that performance of these tests continue to meet specifications. As is true for any laboratory test, on-going assessments of commercial tests are regulated by CLIA. This topic is discussed further in the article Lab Oversight: A Building Block of Trust.

    Read more on FDA Test Classifications

    To learn more about the FDA's clearance and approval process for laboratory tests, visit the FDA webpage on Medical Devices.

  • More Details

    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)