Cleared Traditional

K833063 - WELLCOGEN N. MENINGITIDIS A,C,Y W135

K833063 is an FDA 510(k) clearance for WELLCOGEN N. MENINGITIDIS A, manufactured by Wellcome Diagnostics. The device is a Class 2 Immunology device with product code GTJ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K833063 · Wellcome Diagnostics · Immunology device
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Jan 1984
Decision
123d
Days
Class 2
Risk

K833063 is an FDA 510(k) clearance for the WELLCOGEN N. MENINGITIDIS A,C,Y W135. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3390 - 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.

View all Wellcome Diagnostics devices

FDA 510(k) Submission Details - K833063

510(k) Number K833063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1983
Decision Date January 10, 1984
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 105d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GTJ Device Classification - Class 2, Special Controls

Product Code GTJ Antisera, All Groups, N. Meningitidis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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 - GTJ Antisera, All Groups, N. Meningitidis

All 14
Devices cleared under the same product code (GTJ) and FDA review panel - the closest regulatory comparables to K833063.
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
K844762 · Wellcome Diagnostics · Jun 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · Armkel, LLC · Jul 1984
BACTIGEN-N. MENINGITIDIS
K823880 · Armkel, LLC · Mar 1983
PHADEBACT CSF TEST 20
K822810 · Pharmacia, Inc. · Dec 1982
AGGLUTINATING SERUM W135
K771562 · Burroughs Wellcome Co. · Aug 1977