Cleared Traditional

K162772 - ARIES GBS Assay

K162772 is an FDA 510(k) clearance for ARIES GBS Assay, manufactured by Luminex Corporation. The device is a Class 1 Microbiology device with product code NJR cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K162772 · Luminex Corporation · Microbiology device
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Dec 2016
Decision
81d
Days
Class 1
Risk

K162772 is an FDA 510(k) clearance for the ARIES GBS Assay. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on December 23, 2016 after a review of 81 days - a notably fast clearance 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: 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 Luminex Corporation devices

FDA 510(k) Submission Details - K162772

510(k) Number K162772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2016
Decision Date December 23, 2016
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

NJR Device Classification - Class 1, General Controls

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.

Regulatory Peers - NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

All 13
Devices cleared under the same product code (NJR) and FDA review panel - the closest regulatory comparables to K162772.
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