Cleared Special

K120439 - BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

K120439 is an FDA 510(k) clearance for BIOPLEX 2200 EBV IGG AND SYPHILIS IGG, manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LIP cleared through the Special 510(k) pathway after a 30-day FDA review.

K120439 · Bio-Rad Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
30d
Days
Class 2
Risk

K120439 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGG AND SYPHILIS IGG. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on March 14, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120439

510(k) Number K120439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date March 14, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LIP Device Classification - Class 2, Special Controls

Product Code LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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.

Regulatory Peers - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 34
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K120439.
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K153730 · Abbott Laboratories · Jun 2016
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
SYPHILIS HEALTH CHECK
K102400 · Diagnostics Direct, LLC · Aug 2011
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283 · Zeus Scientific, Inc. · Feb 2011
K120439 · BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
Download PDF FDA Summary Bio-Rad Laboratories,…