Cleared Traditional

K831887 - BACTIGEN S. PNEUMONIAE

K831887 is an FDA 510(k) clearance for BACTIGEN S. PNEUMONIAE, manufactured by Armkel, LLC. The device is a Class 1 Microbiology device with product code GWC cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K831887 · Armkel, LLC · Microbiology device
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Sep 1983
Decision
105d
Days
Class 1
Risk

K831887 is an FDA 510(k) clearance for the BACTIGEN S. PNEUMONIAE. Classified as Antisera, All Types, Streptococcus Pneumoniae (product code GWC), Class I - General Controls.

Submitted by Armkel, LLC (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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 Armkel, LLC devices

FDA 510(k) Submission Details - K831887

510(k) Number K831887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date September 26, 1983
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

GWC Device Classification - Class 1, General Controls

Product Code GWC Antisera, All Types, Streptococcus Pneumoniae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GWC Antisera, All Types, Streptococcus Pneumoniae

All 8
Devices cleared under the same product code (GWC) and FDA review panel - the closest regulatory comparables to K831887.
LKB ULTROBACT (TM) PNEUMOCOCCUS KIT
K862848 · Lkb Instruments, Inc. · Dec 1986
VENTRESCREEN STREP A TEST
K842239 · Ventrex Laboratories, Inc. · Jul 1984
WELLCOGEN S. PNEUMONIAE
K841376 · Wellcome Diagnostics · May 1984
BBL PNEUMOSLIDE TEST
K821960 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1982
PHADEBACT PNEUMOCOCCUS TEST
K802337 · Pharmacia, Inc. · Oct 1980