Cleared Traditional

K080012 - PLATELIA LYME IGG ASSAY

K080012 is an FDA 510(k) clearance for PLATELIA LYME IGG ASSAY, manufactured by Bio-Rad. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K080012 · Bio-Rad · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
126d
Days
Class 2
Risk

K080012 is an FDA 510(k) clearance for the PLATELIA LYME IGG ASSAY. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Bio-Rad (Beverly, US). The FDA issued a Cleared decision on May 8, 2008 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080012

510(k) Number K080012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2008
Decision Date May 08, 2008
Days to Decision 126 days
Submission Type Traditional
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
24d slower than avg
Panel avg: 102d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSR Device Classification - Class 2, Special Controls

Product Code LSR Reagent, Borrelia Serological Reagent
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 - LSR Reagent, Borrelia Serological Reagent

All 111
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K080012.
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
K092693 · Viramed Biotech AG · Nov 2009
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
K082329 · Viramed Biotech AG · Aug 2009
PLATELIA LYME IGM
K081362 · Bio-Rad · Jun 2008
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · DiaSorin, Inc. · Apr 2007
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
K051071 · Viramed Biotech AG · Aug 2005
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
K051169 · Viramed Biotech AG · Aug 2005
K080012 · PLATELIA LYME IGG ASSAY
Download PDF FDA Summary Bio-Rad