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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bcr/Abl1 Monitoring Test
510(k) Number K252243
Device Name Fastplex™ BCR-ABL (p210) %IS digital PCR Kit
Applicant
Suzhou Precigenome, Ltd. Co;
Unit 202-1, Bldg. 1, # 218 Sangtian St., Biobay, Suz
Hou Industrial Park, Suzhou Pilot Free Trade Zone (Jiangsu)
Suzhou,  CN 215000
Applicant Contact Yaqi Wang
Correspondent
Suzhou Precigenome, Ltd. Co;
Unit 202-1, Bldg. 1, # 218 Sangtian St., Biobay, Suz
Hou Industrial Park, Suzhou Pilot Free Trade Zone (Jiangsu)
Suzhou,  CN 215000
Correspondent Contact Yaqi Wang
Regulation Number866.6060
Classification Product Code
OYX  
Subsequent Product Codes
CFR   PHG  
Date Received07/18/2025
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Molecular Genetics
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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