Cleared Traditional

K962037 - IMAGEN RESPIRATORY SCREEN

K962037 is an FDA 510(k) clearance for IMAGEN RESPIRATORY SCREEN, manufactured by Dako Diagnostics , Ltd.. The device is a Class 1 Microbiology device with product code GNW cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K962037 · Dako Diagnostics , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
216d
Days
Class 1
Risk

K962037 is an FDA 510(k) clearance for the IMAGEN RESPIRATORY SCREEN. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), Class I - General Controls.

Submitted by Dako Diagnostics , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on December 26, 1996 after a review of 216 days - an extended review cycle.

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 Dako Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K962037

510(k) Number K962037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1996
Decision Date December 26, 1996
Days to Decision 216 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
114d slower than avg
Panel avg: 102d · This submission: 216d
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 12
Devices cleared under the same product code (GNW) and FDA review panel - the closest regulatory comparables to K962037.
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · Diagnostic Hybrids, Inc. · Dec 2002
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · Light Diagnostics · Apr 1998
IMAGEN RESPIRATORY SCREEN
K973954 · Dako Diagnostics , Ltd. · Dec 1997
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