Cleared Traditional

K862848 - LKB ULTROBACT (TM) PNEUMOCOCCUS KIT (FDA 510(k) Clearance)

Also includes:
2321-110

Class I Microbiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.