Cleared Traditional

K180559 - HSV 1 & 2 ELITe MGB Kit (FDA 510(k) Clearance)

Also includes:
ELITe InGenius

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

K180559 · Elitechgroup · Microbiology device
Oct 2018
Decision
242d
Days
Class 2
Risk

K180559 is an FDA 510(k) clearance for the HSV 1 & 2 ELITe MGB Kit. Classified as Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (product code PGI), Class II - Special Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on October 29, 2018 after a review of 242 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3309 - 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.

Submission Details

510(k) Number K180559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date October 29, 2018
Days to Decision 242 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 174d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGI Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3309
Definition For The Qualitative Detection And Differentiation Of Vzv, Hsv1, Hsv2- Dna In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.
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.