Cleared Traditional

K180264 - Gold Standard Diagnostics Borrelia burg...

K180264 is an FDA 510(k) clearance for Gold Standard Diagnostics Borrelia burg..., manufactured by Gold Standard Diagnostics. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K180264 · Gold Standard Diagnostics · Microbiology device
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May 2018
Decision
92d
Days
Class 2
Risk

K180264 is an FDA 510(k) clearance for the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on May 2, 2018 after a review of 92 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.

View all Gold Standard Diagnostics devices

FDA 510(k) Submission Details - K180264

510(k) Number K180264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2018
Decision Date May 02, 2018
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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 63
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