Cleared Traditional

K220924 - Elecsys HSV-2 IgG (08948887160)

K220924 is an FDA 510(k) clearance for Elecsys HSV-2 IgG (08948887160), manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code MYF cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K220924 · Roche Diagnostics · Microbiology device
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Oct 2022
Decision
195d
Days
Class 2
Risk

K220924 is an FDA 510(k) clearance for the Elecsys HSV-2 IgG (08948887160). Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (product code MYF), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 12, 2022 after a review of 195 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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 Roche Diagnostics devices

FDA 510(k) Submission Details - K220924

510(k) Number K220924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2022
Decision Date October 12, 2022
Days to Decision 195 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
93d slower than avg
Panel avg: 102d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYF Device Classification - Class 2, Special Controls

Product Code MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 - MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

All 7
Devices cleared under the same product code (MYF) and FDA review panel - the closest regulatory comparables to K220924.
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K243575 · Biokit, S.A. · Feb 2025
SeraQuest HSV Type 2 Specific IgG
K181514 · Quest International, Inc. · Jun 2019
ADVIA Centaur Herpes-2 IgG
K181334 · Biokit, S.A. · Aug 2018
SeraQuest HSV Type 2 Specific IgG
K152353 · Quest International, Inc. · May 2016
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603 · Zeus Scientific, Inc. · May 2011
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K081687 · DiaSorin, Inc. · Nov 2008