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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameelectrochemiluminescence assay for the determination of prostate specific antigen;psa calibrator
Regulation Number866.6010
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990056
Supplement NumberS001
Date Received10/09/2001
Decision Date02/08/2002
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the addition of the assay to the modular analytics e170 (elecsys module) immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys total psa immunoassay and elecsys total psa calset and are indicated as follows: the elecsys total psa immunoassay, a quantitative in vitro diagnostic test for total prostate-specific antigen (tpsa) in human serum and plasma, is indicated for the measurement of total psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The test is further indicated for serial measurement of tpsa to aid in the management of cancer patients. The electrochemilumin-escence immunoassay "eclia" is intended for use on the roche elecsys 1010/2010 and modular analytics e170 (elecsys module) immunoassay analyzers.
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