Cleared Traditional

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

K170509 · Bio-Rad Laboratories · Microbiology

May 2017

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K170509 is an FDA 510(k) clearance for the BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set, a Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm (Class II — Special Controls, product code PUQ), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on May 19, 2017, 87 days after receiving the submission on February 21, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K170509 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2017
Decision Date	May 19, 2017
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PUQ — Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3510
Definition	The Kit Is A Multiplex Flow Immunoassay Intended For The Qualitative Detection Of Igm Antibodies To Toxoplasma Gondii (t. Gondii), Rubella, And Cytomegalovirus (cmv) In Human Serum And Plasma.