Cleared Traditional

K111860 - BD MAX GBS ASSAY, BD MAX INSTRUMENT (FDA 510(k) Clearance)

Class I Microbiology device.

K111860 · Becton, Dickinson & CO · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 2012
Decision
231d
Days
Class 1
Risk

K111860 is an FDA 510(k) clearance for the BD MAX GBS ASSAY, BD MAX INSTRUMENT. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 231 days - an extended review cycle.

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.

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Submission Details

510(k) Number K111860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2011
Decision Date February 16, 2012
Days to Decision 231 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 102d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
Definition A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status.
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.