510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252243Substantially Equivalent

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

Suzhou Precigenome, Ltd. Co, Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252243 is the FDA 510(k) clearance record for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit, a class II device, cleared for Suzhou Precigenome, Ltd. Co; on under FDA product code OYX (Bcr/Abl1 Monitoring Test). FDA's definition for product code OYX reads: "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...". FDA records list one 510(k) clearance for Suzhou Precigenome, Ltd. Co;. As of , FDA records show no recalls naming K252243.

Clearance record

Decision date
Received
(349 days to decision)
Product code
OYX Bcr/Abl1 Monitoring Test
Regulation
21 CFR 866.6060
Device class
Class II
Review panel
Medical Genetics
Applicant
Suzhou Precigenome, Ltd. Co; Unit 202-1, Bldg. 1, # 218 Sangtian St., Biobay, Suz, Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYX

Trailing 12 months
1 clearance under product code OYX in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OYX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260