Cleared Traditional

K252243 - Fastplex BCR-ABL (p210) %IS digital PCR Kit

K252243 is an FDA 510(k) clearance for Fastplex BCR-ABL (p210) %IS digital PCR Kit, manufactured by Suzhou Precigenome, Ltd. Co;. The device is a Class 2 Medical Genetics device with product code OYX cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K252243 · Suzhou Precigenome, Ltd. Co; · Medical Genetics device
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Jul 2026
Decision
349d
Days
Class 2
Risk

K252243 is an FDA 510(k) clearance for the Fastplex™ BCR-ABL (p210) %IS digital PCR Kit. Classified as Bcr/abl1 Monitoring Test (product code OYX), Class II - Special Controls.

Submitted by Suzhou Precigenome, Ltd. Co; (Suzhou, CN). The FDA issued a Cleared decision on July 2, 2026 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Suzhou Precigenome, Ltd. Co; devices

FDA 510(k) Submission Details - K252243

510(k) Number K252243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2025
Decision Date July 02, 2026
Days to Decision 349 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 397d · This submission: 349d
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 K252243.
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