Cleared Traditional

K221869 - BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221869 · Suzhou Sniper Medical Technologies Co., Ltd. · Medical Genetics device
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Sep 2023
Decision
434d
Days
Class 2
Risk

K221869 is an FDA 510(k) clearance for the BCR-ABL1 (p210) % IS Kit (Digital PCR Method). Classified as Bcr/abl1 Monitoring Test (product code OYX), Class II - Special Controls.

Submitted by Suzhou Sniper Medical Technologies Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 5, 2023 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Medical Genetics submissions.

View all Suzhou Sniper Medical Technologies Co., Ltd. devices

Submission Details

510(k) Number K221869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2022
Decision Date September 05, 2023
Days to Decision 434 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
35d slower than avg
Panel avg: 399d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Sinow Medical AS
Huifang Zhao

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.