IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

FDA premarket approval P930027/S004 · decided 2001-06-19

Approval details

PMA number

P930027

Supplement

S004

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

Generic name

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Applicant

Siemens Healthcare Diagnostics, Inc.

Date received

2001-01-02

Decision date

2001-06-19

Days to decision

168 days

Decision code

APPR

Product code

LTJ

Advisory committee

Immunology

Expedited review

No

Location

Gwynedd Ll55 4el

Statement

IMMULITE PSA, IMMULITE. THIRD GENERATION PSA, IMMULITE 2000 PSA, AND IMMULITE 2000 THIRD GENERATION PSA. IMMULITE. PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER. IMMULITE THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE

510(k) clearances by this applicant