Cleared Traditional

K170509 - BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170509 · Bio-Rad Laboratories · Microbiology device
May 2017
Decision
87d
Days
Class 2
Risk

K170509 is an FDA 510(k) clearance for the BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToR.... Classified as Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm (product code PUQ), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on May 19, 2017 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K170509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 174d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PUQ Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.