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Advisory Committees

Microbiology Devices Panel - January 20-21, 2000

On January 20, 2000, the Microbiology Devices Panel voted and made recommendations on six premarket approval applications (PMAs) from DiaSorin Biomedica. The Panel voted unanimously that the PMAs be Approved with conditions.

PMA #1: ETI-MAK 2 Plus (HBsAg) The panel recommended as conditions of approval that pre-market studies be conducted: (1) to demonstrate the use of HBsAg in pregnant women, (2) to obtain data on acute/chronic infections in high-risk populations such as HIV, STD, immunosuppresssed, (3) to obtain data on patients meeting the standard definition for chronicity, i.e., ³ 6 months of infection, and (4) that samples with reactive results be repeat tested to confirm the test reactivity.

PMA#2: ETI-AB-AUK Plus (Anti-HBs) The panel recommended as conditions of approval that the same conditions (# 2-3) be applied to the Anti-HBsAg PMA. In addition, the sponsor should obtain additional data on individuals who have completed the Hep B vaccine series (e.g. 3-9 months post 3rd dose)

PMA#3: ETI-EBK Plus (HBeAg) The panel recommended as conditions of approval that the HBeAg also meet conditions #2-3 as the HBsAg and in addition, that the sponsor conduct further studies to document the performance of the device when used for monitoring of patients on therapy, and the device label should state that the assay should be run only if HBsAg is reactive.

PMA#4: ETI-AB-EBK Plus (Anti-HBeAg) The panel recommended that the same Conditions recommended for PMA #3 be applied to the Anti-HBeAg.

PMA#5: ETI-AB-COREK Plus (Anti-HBc- total Antibody) The panel recommended that the conditions # 2-4 recommended for the HBsAg be applied to the Total Anti-HBc. In addition, they recommended that the terms "monitoring acute and chronic" be removed from the intended use statement.

PMA# 6: ETI-CORE IGMK Plus (Anti-HBc IgM) The panel recommended that the conditions # 2-3 recommended for the anti-HBs be applied to this device also. In addition, the panel recommended that the sponsor conduct additional studies to evaluate the performance of more anti-HBc IgM reactive samples.

On the second day, the Panel voted Approvable with Conditions for the Abbott AxSYM HCV PMA. The conditions were; 1) That a statement such as "Reactive specimens should be confirmed by a more specific test before reporting as reactive" should be prominently placed in the package insert, either after indications for use or bolded as a Limitation. And 2) the performance data showing different disease stages, e.g. acute and chronic, should be prefaced with a statement to clarify that "delineation of different categories are descriptive of populations tested and do not represent any claim for performance in these populations."

The panel also provided recommendations on issues that concern the use of characterized hepatitis panels (archival specimens) in assessing the performance of in vitro diagnostic devices for the determination of hepatitis infection as an alternative to conducting intensive prospective clinical trials. The panel suggested that these panels supplement but not replace prospective clinical trials. They stated that archival specimens could be helpful, but depending on the type hepatitis study they would be used in, different criteria would be needed. They cautioned the FDA that criteria or guidelines should clearly specify collection procedures, use of anticoagulants, storage conditions, sample sizes or aliquots. They recommended that the FDA obtain exact criteria for characterizing specimens from a consensus of hepatologists.

During the Open Public Hearing Session a representative from Boston Biomedica, Inc. presented information on the hepatitis panels, which they manufacture and are currently being used in various clinical trials.

Contact: Freddie M. Poole, Executive Secretary, 301-594-2096, x 111

Transcripts may be purchased from: (written only)

Miller Reporting
507 C Street, NE
Washington, DC 20002
(202) 546-6666 (voice) (202) 546-1502 (fax)


Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

Executive Summary may be purchased from: (written request only)

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

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