Cleared Traditional

K252627 - Lyme-ID IgG Test (FDA 510(k) Clearance)

Also includes:
Bio-ID800

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

K252627 · Inanovate, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
86d
Days
Class 2
Risk

K252627 is an FDA 510(k) clearance for the Lyme-ID IgG Test. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Inanovate, Inc. (Sioux Falls, US). The FDA issued a Cleared decision on November 14, 2025 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inanovate, Inc. devices

Submission Details

510(k) Number K252627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2025
Decision Date November 14, 2025
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
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 K252627.
iDart Lyme IgM ImmunoBlot Kit
K242872 · Id-Fish Technology, Inc. · Jun 2025
iDart Lyme IgG ImmunoBlot Kit
K233367 · Id-Fish Technology, Inc. · Aug 2024
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System
K230863 · Zeus Scientific · Jul 2023
Viramed Borrela All-In-One ViraChip Test Kit
K220016 · Viramed Biotech AG · Aug 2022
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · Gold Standard Diagnostics · Mar 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · Gold Standard Diagnostics · Mar 2021