Cleared Traditional

K021486 - HERPESELECT 2 ELISA IGG, MODEL ELO920G

K021486 is an FDA 510(k) clearance for HERPESELECT 2 ELISA IGG, manufactured by Focus Technologies, Inc.. The device is a Class 2 Microbiology device with product code MXJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021486 · Focus Technologies, Inc. · Microbiology device
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Aug 2002
Decision
90d
Days
Class 2
Risk

K021486 is an FDA 510(k) clearance for the HERPESELECT 2 ELISA IGG, MODEL ELO920G. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), Class II - Special Controls.

Submitted by Focus Technologies, Inc. (Cypress, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 90 days - within the typical 510(k) review window.

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 Focus Technologies, Inc. devices

FDA 510(k) Submission Details - K021486

510(k) Number K021486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date August 01, 2002
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

All 11
Devices cleared under the same product code (MXJ) and FDA review panel - the closest regulatory comparables to K021486.
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K993754 · Mrl Diagnostics · Feb 2000
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · Meridian Diagnostics, Inc. · Jun 1999