Cleared Traditional

K991880 - LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IM...

K991880 is an FDA 510(k) clearance for LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IM..., manufactured by Light Diagnostics. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K991880 · Light Diagnostics · Microbiology device
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Nov 1999
Decision
160d
Days
Class 2
Risk

K991880 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 160 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 Light Diagnostics devices

FDA 510(k) Submission Details - K991880

510(k) Number K991880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1999
Decision Date November 09, 1999
Days to Decision 160 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
58d slower than avg
Panel avg: 102d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQN Device Classification - Class 2, Special Controls

Product Code GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
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 - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 20
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K991880.
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