Cleared Traditional

K062948 - SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

K062948 is an FDA 510(k) clearance for SMART GBS AND SMARTCYCLE DX SYSTEM AND ..., manufactured by Cepheid. The device is a Class 1 Microbiology device with product code NJR cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K062948 · Cepheid · Microbiology device
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Dec 2006
Decision
71d
Days
Class 1
Risk

K062948 is an FDA 510(k) clearance for the SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on December 8, 2006 after a review of 71 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 Cepheid devices

FDA 510(k) Submission Details - K062948

510(k) Number K062948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date December 08, 2006
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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 K062948.
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · Meridian Bioscience, Inc. · May 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · Becton, Dickinson & CO · Feb 2012
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · Meridian Bioscience, Inc. · Dec 2011
XPERT, GENEXPERT DX SYSTEM
K060540 · Cepheid · Jul 2006