Cleared Traditional

K173492 - MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

K173492 is an FDA 510(k) clearance for MRDx BCR-ABL Test, manufactured by MolecularMD Corporation. The device is a Class 2 Pathology device with product code OYX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K173492 · MolecularMD Corporation · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
39d
Days
Class 2
Risk

K173492 is an FDA 510(k) clearance for the MRDx BCR-ABL Test, MRDx BCR-ABL Test Software. Classified as Bcr/abl1 Monitoring Test (product code OYX), Class II - Special Controls.

Submitted by MolecularMD Corporation (Portland, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6060 - 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: 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 MolecularMD Corporation devices

FDA 510(k) Submission Details - K173492

510(k) Number K173492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received November 13, 2017
Decision Date December 22, 2017
Days to Decision 39 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 78d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

OYX Device Classification - Class 2, Special Controls

Product Code OYX Bcr/abl1 Monitoring Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6060
Definition A Bcr/abl1 Monitoring Test Is A Quantitative In Vitro Diagnostic Device Used To Monitor The Bcr/abl1 To Abl1 Ratio By Reverse-transcriptase Quantitative Polymerase Chain Reaction (rq-pcr) On Whole Blood Or Bone Marrow Of Diagnosed Philadelphia Chromosome Positive (ph+) Chronic Myeloid Leukemia (cml) Patients Expressing Bcr-abl1 Fusion Transcripts Such As E13a2 And/or E14a2. It Is Intended For Use During Monitoring Of Treatment Response By Reporting Results On The International Scale (%is) And As Log Molecular Reduction (mr) Value.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Pathology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01698905 Completed Interventional Industry-sponsored

Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib

163
Patients (actual)
62
Sites
Treatment
Purpose
Open label
Masking
Condition studied Chronic Myeloid Leukemia
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Novartis Pharmaceuticals
Sponsor Novartis Pharmaceuticals (industry)
Started 2012-12-20 → Primary completion 2015-11-26 → Completed 2025-01-29
Primary outcome
Percentage of Participants in TFR Within 48-weeks Following Nilotinib Cessation
Secondary outcome
Percentage of Participants in TFR Within 96, 144, 192, 264 Weeks, and Within the End of Years 6, 7, 8, 9 and 10 Following Nilotinib Cessation
View full study on ClinicalTrials.gov

Regulatory Peers - OYX Bcr/abl1 Monitoring Test

Devices cleared under the same product code (OYX) and FDA review panel - the closest regulatory comparables to K173492.
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
K221869 · Suzhou Sniper Medical Technologies Co., Ltd. · Sep 2023
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
K190076 · Cepheid · Sep 2019
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
K181661 · Bio-Rad Laboratories, Inc. · Feb 2019
Quantidex qPCR BCR-ABL IS Kit
DEN160003 · Asuragen, Inc. · Jul 2016