Cleared Traditional

K060540 - XPERT, GENEXPERT DX SYSTEM

K060540 is an FDA 510(k) clearance for XPERT, manufactured by Cepheid. The device is a Class 1 Microbiology device with product code NJR cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K060540 · Cepheid · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
146d
Days
Class 1
Risk

K060540 is an FDA 510(k) clearance for the XPERT, GENEXPERT DX SYSTEM. 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 July 25, 2006 after a review of 146 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.

FDA 510(k) Submission Details - K060540

510(k) Number K060540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2006
Decision Date July 25, 2006
Days to Decision 146 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
44d slower than avg
Panel avg: 102d · This submission: 146d
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 17
Devices cleared under the same product code (NJR) and FDA review panel - the closest regulatory comparables to K060540.
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · Meridian Bioscience, Inc. · Dec 2011
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
K090191 · Handylab, Inc. · May 2010
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
K062948 · Cepheid · Dec 2006
IDI-STREP B ASSAY
K022504 · Infectio Diagnostic, Inc. · Nov 2002
K060540 · XPERT, GENEXPERT DX SYSTEM
Download PDF FDA Summary Cepheid