Cleared Traditional

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET (K080008) - FDA 510(k) Clearance

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

K080008 · Bio-Rad Laboratories, Inc. · Microbiology device
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Feb 2009
Decision
418d
Days
Class 2
Risk

K080008 is an FDA 510(k) clearance for the BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET. Classified as Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv (product code OMI), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 23, 2009 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K080008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2008
Decision Date February 23, 2009
Days to Decision 418 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 102d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
Definition The Kit Is A Multiplex Immunoassay Intended For The Quantitative Detection Of Igg Antibodies To Toxoplasma Gondii (t. Gondii) And Rubella, And Qualitative Detection Of Cytomegalovirus (cmv) Igg In Human Serum And/ Or Plasma. Indicated As An Aid In The Determination Of Serological Status To T. Gondii, Rubella And Cmv. This Kit Is Not Intended For Use In Screening Blood Or Plasma Donors.
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.