IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

FDA premarket approval P930027/S006 · decided 2003-12-31

Approval details

PMA number

P930027

Supplement

S006

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Generic name

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

Applicant

Siemens Healthcare Diagnostics, Inc.

Date received

2003-11-28

Decision date

2003-12-31

Days to decision

33 days

Decision code

APPR

Product code

LTJ

Advisory committee

Immunology

Expedited review

No

Location

Gwynedd Ll55 4el

Statement

APPROVAL FOR THE INTRODUCTION OF THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA TESTS FOR USE ON THE IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2500 PSA AND IMMULITE 2500 THIRD GENERATION PSA ASSAYS FOR THE FOLLOWING INDICATION: "THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA ASSAYS ARE FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2500 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECI

510(k) clearances by this applicant