Cleared Traditional

K233367 - iDart Lyme IgG ImmunoBlot Kit (FDA 510(k) Clearance)

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

K233367 · Id-Fish Technology, Inc. · Microbiology device
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Aug 2024
Decision
315d
Days
Class 2
Risk

K233367 is an FDA 510(k) clearance for the iDart Lyme IgG ImmunoBlot Kit. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Id-Fish Technology, Inc. (Milpitas, US). The FDA issued a Cleared decision on August 12, 2024 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Id-Fish Technology, Inc. devices

Submission Details

510(k) Number K233367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2023
Decision Date August 12, 2024
Days to Decision 315 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
213d slower than avg
Panel avg: 102d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 110
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K233367.
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Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
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Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · Gold Standard Diagnostics · Mar 2021