Cleared Traditional

K990141 - LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IM...

K990141 is an FDA 510(k) clearance for LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IM..., manufactured by Light Diagnostics. The device is a Class 2 Microbiology device with product code GQW cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K990141 · Light Diagnostics · Microbiology device
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Oct 1999
Decision
273d
Days
Class 2
Risk

K990141 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295. Classified as Antigen, Cf, (including Cf Control), Varicella-zoster (product code GQW), Class II - Special Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on October 19, 1999 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 Light Diagnostics devices

FDA 510(k) Submission Details - K990141

510(k) Number K990141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date October 19, 1999
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQW Device Classification - Class 2, Special Controls

Product Code GQW Antigen, Cf, (including Cf Control), Varicella-zoster
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3900
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 - GQW Antigen, Cf, (including Cf Control), Varicella-zoster

Devices cleared under the same product code (GQW) and FDA review panel - the closest regulatory comparables to K990141.
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206 · Diagnostic Hybrids, Inc. · Aug 2007
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1991
VARICELLA-ZOSTER(IGG) IFA TEST
K841434 · Zeus Scientific, Inc. · Apr 1985
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · Orion Diagnostica, Inc. · Dec 1980