Cleared Traditional

K111951 - ISOAMP HSV ASSAY

K111951 is the FDA 510(k) clearance for ISOAMP HSV ASSAY by Biohelix Corporation. It is a Class 2 Microbiology device (product code OQO) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K111951 · Biohelix Corporation · Microbiology device
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Sep 2011
Decision
81d
Days
Class 2
Risk

K111951 is an FDA 510(k) clearance for the ISOAMP HSV ASSAY. Classified as Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO), Class II - Special Controls.

Submitted by Biohelix Corporation (Beverly, US). The FDA issued a Cleared decision on September 27, 2011 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biohelix Corporation devices

Submission Details

510(k) Number K111951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date September 27, 2011
Days to Decision 81 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
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
Definition A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens.
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 - OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

Devices cleared under the same product code (OQO) and FDA review panel - the closest regulatory comparables to K111951.
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · Hologic, Inc. · Jun 2017
cobas HSV 1 and 2 Test
K150617 · Roche Molecular Systems, Inc. · Jun 2015
AMIPLIVUE HSV 1&2 ASSAY
K140029 · Quidel Corporation · Mar 2014
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
K103798 · Becton, Dickinson & CO · Mar 2011