VERSANT HCV RNA 3.0 ASSAY (BDNA)

FDA premarket approval P020022/S006 · decided 2007-12-14

Approval details

PMA number

P020022

Supplement

S006

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VERSANT HCV RNA 3.0 ASSAY (BDNA)

Generic name

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Applicant

Siemens Healthcare Diagnostics, Inc.

Date received

2007-02-22

Decision date

2007-12-14

Days to decision

295 days

Decision code

APPR

Product code

MZP

Advisory committee

Microbiology

Expedited review

No

Location

Berkeley, CA

Statement

APPROVAL FOR THE ADDITION OF THE VERSANT 440 MOLECULAR SYSTEM (SYSTEM 400). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA AND IS INDICATED FOR: THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE DIRECT QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA OF HCV INFECTED INDIVIDUALS USING THE SYSTEM 340 BDNA ANALYZER OR THE VERSANT 440 MOLECULAR SYSTEM. SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE

510(k) clearances by this applicant