Cleared Traditional

K862848 - LKB ULTROBACT (TM) PNEUMOCOCCUS KIT

Also marketed or referenced as:
2321-110

K862848 is an FDA 510(k) clearance for LKB ULTROBACT (TM) PNEUMOCOCCUS KIT, manufactured by Lkb Instruments, Inc.. The device is a Class 1 Microbiology device with product code GWC cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K862848 · Lkb Instruments, Inc. · Microbiology device
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Dec 1986
Decision
142d
Days
Class 1
Risk

K862848 is an FDA 510(k) clearance for the LKB ULTROBACT (TM) PNEUMOCOCCUS KIT. Classified as Antisera, All Types, Streptococcus Pneumoniae (product code GWC), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on December 18, 1986 after a review of 142 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 Lkb Instruments, Inc. devices

FDA 510(k) Submission Details - K862848

510(k) Number K862848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date December 18, 1986
Days to Decision 142 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
40d slower than avg
Panel avg: 102d · This submission: 142d
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 K862848.
BACTIGEN(R) MENINGITIDIS PANEL
K884965 · Armkel, LLC · Feb 1989
BACTIGEN(R) S. PNEUMONIAE
K884966 · Armkel, LLC · Feb 1989
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
K870029 · American Micro Scan · Mar 1987
VENTRESCREEN STREP A TEST
K842239 · Ventrex Laboratories, Inc. · Jul 1984
WELLCOGEN S. PNEUMONIAE
K841376 · Wellcome Diagnostics · May 1984
BACTIGEN S. PNEUMONIAE
K831887 · Armkel, LLC · Sep 1983