Cleared Traditional

K841191 - MICROTRAKSPECIMAN ID TYPING TEST CONTR

K841191 is an FDA 510(k) clearance for MICROTRAKSPECIMAN ID TYPING TEST CONTR, manufactured by Syva Co.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K841191 · Syva Co. · Microbiology device
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Jun 1984
Decision
90d
Days
Class 2
Risk

K841191 is an FDA 510(k) clearance for the MICROTRAKSPECIMAN ID TYPING TEST CONTR. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 19, 1984 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 Syva Co. devices

FDA 510(k) Submission Details - K841191

510(k) Number K841191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1984
Decision Date June 19, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 22
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K841191.
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · Bartels Immunodiagnostic Supplies, Inc. · Nov 1985
HERPES SIMPLEX GROUP CF ANTIGEN
K850609 · Hillcrest Biologicals · May 1985
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · Cordis Corp. · Apr 1985
CORDIA HS
K832875 · Cordis Corp. · Nov 1983