Cleared Traditional

K170557 - GenePOC GBS LB

K170557 is an FDA 510(k) clearance for GenePOC GBS LB, manufactured by Genepoc, Inc.. The device is a Class 1 Microbiology device with product code NJR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K170557 · Genepoc, Inc. · Microbiology device
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May 2017
Decision
90d
Days
Class 1
Risk

K170557 is an FDA 510(k) clearance for the GenePOC GBS LB. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on May 25, 2017 after a review of 90 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 Genepoc, Inc. devices

FDA 510(k) Submission Details - K170557

510(k) Number K170557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2017
Decision Date May 25, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
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 15
Devices cleared under the same product code (NJR) and FDA review panel - the closest regulatory comparables to K170557.
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