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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.
Classification Nameanalyzer, chemistry (photometric, discrete), for clinical use
Generic Nameanalyzer, chemistry (photometric, discrete), for clinical use
Regulation Number862.2160
Abbott Laboratories
100 abbott park rd.
abbott park, IL 60064-3500
PMA NumberP910007
Supplement NumberS013
Date Received05/05/2005
Decision Date06/13/2005
Product Code
JJE[ Registered Establishments with JJE ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the new method comparisons between the imx total psa assay and the imx psa assay. The comparisons include regression analyses (passing-bablok and least squares linear regression) and bias analysis. The device, as modified, will be marketed under the same trade name imx total psa assay and is indicated as follows: the imx total psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of total psa (both free psa and psa complexed to alpha-1-antichymotrypsin) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostatic biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients.