Cleared Traditional

SeraQuest HSV Type 2 Specific IgG (K181514) - FDA 510(k) Clearance

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

K181514 · Quest International, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
370d
Days
Class 2
Risk

K181514 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. (Palm City, US). The FDA issued a Cleared decision on June 13, 2019 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Quest International, Inc. devices

Submission Details

510(k) Number K181514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2018
Decision Date June 13, 2019
Days to Decision 370 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
268d slower than avg
Panel avg: 102d · This submission: 370d
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.