Cleared Traditional

K162276 - SeraQuest Herpes Type 1 Specific IgG (FDA 510(k) Clearance)

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

K162276 · Quest International, Inc. · Microbiology device
Oct 2016
Decision
50d
Days
Class 2
Risk

K162276 is an FDA 510(k) clearance for the SeraQuest Herpes Type 1 Specific IgG. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II - Special Controls, product code MXJ).

Submitted by Quest International, Inc. (Mami, US). The FDA issued a Cleared decision on October 1, 2016, 50 days after receiving the submission on August 12, 2016.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K162276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2016
Decision Date October 01, 2016
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 174d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
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.