Cleared Traditional

K823880 - BACTIGEN-N. MENINGITIDIS

K823880 is an FDA 510(k) clearance for BACTIGEN-N. MENINGITIDIS, manufactured by Armkel, LLC. The device is a Class 2 Microbiology device with product code GTJ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K823880 · Armkel, LLC · Microbiology device
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Mar 1983
Decision
72d
Days
Class 2
Risk

K823880 is an FDA 510(k) clearance for the BACTIGEN-N. MENINGITIDIS. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Armkel, LLC (Walker, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Armkel, LLC devices

FDA 510(k) Submission Details - K823880

510(k) Number K823880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date March 09, 1983
Days to Decision 72 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
30d faster than avg
Panel avg: 102d · This submission: 72d
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 Microbiology 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 K823880.
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · Armkel, LLC · Jul 1984
WELLCOGEN N. MENINGITIDIS A,C,Y W135
K833063 · Wellcome Diagnostics · Jan 1984
PHADEBACT CSF TEST 20
K822810 · Pharmacia, Inc. · Dec 1982
AGGLUTINATING SERUM W135
K771562 · Burroughs Wellcome Co. · Aug 1977