Cleared Traditional

POCKIT HSV 2 RAPID TEST (K983886) - FDA 510(k) Clearance

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

K983886 · Diagnology , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
290d
Days
Class 2
Risk

K983886 is an FDA 510(k) clearance for the POCKIT HSV 2 RAPID TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Diagnology , Ltd. (West Cadwell, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 290 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 Diagnology , Ltd. devices

Submission Details

510(k) Number K983886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date August 19, 1999
Days to Decision 290 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
188d slower than avg
Panel avg: 102d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
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 - LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

All 37
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K983886.
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · Diagnostic Products Corp. · Apr 2001
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp. · Jun 1996
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · Eastman Kodak Company · Sep 1990
HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · Eastman Kodak Company · Feb 1989
ABBOTT HSV EIA
K843622 · Abbott Laboratories · May 1985