Cleared Traditional

K181661 - QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

K181661 is an FDA 510(k) clearance for QXDx BCR-ABL %IS Kit for use on the QXD..., manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 2 Medical Genetics device with product code OYX cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K181661 · Bio-Rad Laboratories, Inc. · Medical Genetics device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
233d
Days
Class 2
Risk

K181661 is an FDA 510(k) clearance for the QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System. Classified as Bcr/abl1 Monitoring Test (product code OYX), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 13, 2019 after a review of 233 days - an extended review cycle.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6060 - the FDA medical genetics 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 Medical Genetics review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Rad Laboratories, Inc. devices

FDA 510(k) Submission Details - K181661

510(k) Number K181661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date February 13, 2019
Days to Decision 233 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d faster than avg
Panel avg: 397d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Medical Genetics devices follow this clearance model.

Regulatory Peers - OYX Bcr/abl1 Monitoring Test

Devices cleared under the same product code (OYX) and FDA review panel - the closest regulatory comparables to K181661.
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit
K252243 · Suzhou Precigenome, Ltd. Co; · Jul 2026
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
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
K173492 · MolecularMD Corporation · Dec 2017
Quantidex qPCR BCR-ABL IS Kit
DEN160003 · Asuragen, Inc. · Jul 2016