Cleared Traditional

K090901 - ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8

K090901 is an FDA 510(k) clearance for ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, manufactured by Osmetech Molecular Diagnostics. The device is a Class 2 Pathology device with product code NUA cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K090901 · Osmetech Molecular Diagnostics · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
96d
Days
Class 2
Risk

K090901 is an FDA 510(k) clearance for the ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPIN.... Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (product code NUA), Class II - Special Controls.

Submitted by Osmetech Molecular Diagnostics (Pasadena, US). The FDA issued a Cleared decision on July 6, 2009 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5900 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Osmetech Molecular Diagnostics devices

FDA 510(k) Submission Details - K090901

510(k) Number K090901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date July 06, 2009
Days to Decision 96 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 77d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUA Device Classification - Class 2, Special Controls

Product Code NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5900
Definition The Cftr Gene Mutation Detection System Is A Device Used To Simultaneously Detect And Identify A Panel Of Mutations And Variants In The Cftr Gene. It Is Intended As An Aid In Confirmatory Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (cf), Carrier Identification, And Newborn Screening. This Device Is Not Intended For Stand-alone Diagnostic Purposes, Prenatal Diagnostic, Pre-implantation Or Population Screening.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

All 11
Devices cleared under the same product code (NUA) and FDA review panel - the closest regulatory comparables to K090901.
XTAG CF60 KIT V2
K083845 · Luminex Molecular Diagnostics, Inc. · Dec 2009
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
K083846 · Luminex Molecular Diagnostics, Inc. · Sep 2009
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
K083294 · Nanosphere, Inc. · Jul 2009
INPLEX CF MOLECULAR TEST
K063787 · Third Wave Technologies, Inc. · Mar 2008
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
K062028 · Celera Diagnostics · Sep 2007
TAG-IT CYSTIC FIBROSIS KIT
K060627 · Tm Bioscience Corporation · Jun 2006