Cleared Traditional

SeraQuest HSV Type 2 Specific IgG (K152353) - FDA 510(k) Clearance

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

K152353 · Quest International, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
267d
Days
Class 2
Risk

K152353 is an FDA 510(k) clearance for the SeraQuest HSV Type 2 Specific IgG. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (product code MYF), Class II - Special Controls.

Submitted by Quest International, Inc. (Mami, US). The FDA issued a Cleared decision on May 13, 2016 after a review of 267 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 Quest International, Inc. devices

Submission Details

510(k) Number K152353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date May 13, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 102d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (MYF) and FDA review panel - the closest regulatory comparables to K152353.
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K243575 · Biokit, S.A. · Feb 2025
Elecsys HSV-2 IgG (08948887160)
K220924 · Roche Diagnostics · Oct 2022
SeraQuest HSV Type 2 Specific IgG
K181514 · Quest International, Inc. · Jun 2019
ADVIA Centaur Herpes-2 IgG
K181334 · Biokit, S.A. · Aug 2018