Cleared Traditional

K974302 - LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

K974302 is an FDA 510(k) clearance for LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B, manufactured by Light Diagnostics. The device is a Class 1 Microbiology device with product code GNW cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K974302 · Light Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
142d
Days
Class 1
Risk

K974302 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), Class I - General Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on April 8, 1998 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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 - K974302

510(k) Number K974302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date April 08, 1998
Days to Decision 142 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
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

GNW Device Classification - Class 1, General Controls

Product Code GNW Antisera, Cf, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GNW Antisera, Cf, Influenza Virus A, B, C

All 10
Devices cleared under the same product code (GNW) and FDA review panel - the closest regulatory comparables to K974302.
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · Diagnostic Hybrids, Inc. · Dec 2008
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101 · Diagnostic Hybrids, Inc. · Nov 2006
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · Diagnostic Hybrids, Inc. · Dec 2002
INFLUENZA A ANTIGEN TEST
K942172 · Neogenex · Jul 1994
INFLUENZA B ANITGEN TEST
K942174 · Neogenex · Jun 1994
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · Gull Laboratories, Inc. · Dec 1991