Cleared Traditional

K832541 - SIMPLEX-2

K832541 is an FDA 510(k) clearance for SIMPLEX-2, manufactured by Gentech Australia. The device is a Class 2 Immunology device with product code GQN cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K832541 · Gentech Australia · Immunology device
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Feb 1984
Decision
190d
Days
Class 2
Risk

K832541 is an FDA 510(k) clearance for the SIMPLEX-2. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Gentech Australia (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 190 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3305 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K832541

510(k) Number K832541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date February 04, 1984
Days to Decision 190 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 105d · This submission: 190d
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 Immunology devices follow this clearance model.

Regulatory Peers - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 31
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K832541.
HERPES SIMPLEX GROUP CF ANTIGEN
K850609 · Hillcrest Biologicals · May 1985
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · Cordis Corp. · Apr 1985
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · Syva Co. · Jun 1984
CORDIA HS
K832875 · Cordis Corp. · Nov 1983
HERPES
K811021 · Immuno-Diagnostic Products, Inc. · Nov 1981
K832541 · SIMPLEX-2
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