Cleared Traditional

K143312 - Portrait GBS Assay

K143312 is the FDA 510(k) clearance for Portrait GBS Assay by Great Basin Corporation. It is a Class 1 Microbiology device (product code NJR) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K143312 · Great Basin Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
154d
Days
Class 1
Risk

K143312 is an FDA 510(k) clearance for the Portrait GBS Assay. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Great Basin Corporation (Salt Lake City, US). The FDA issued a Cleared decision on April 21, 2015 after a review of 154 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.

View all Great Basin Corporation devices

Submission Details

510(k) Number K143312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2014
Decision Date April 21, 2015
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
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.

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 K143312.
Panther Fusion GBS Assay
K181156 · Diagenode · Jul 2018
NeuMoDx GBS Assay
K173725 · Neumodx Molecular, Inc. · Jun 2018
Solana GBS Assay
K173250 · Quidel Corporation · Dec 2017
AMPLIVUE GBS ASSAY
K133503 · Quidel Corporation · Dec 2013
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
K121539 · Cepheid · Nov 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · Meridian Bioscience, Inc. · May 2012