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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K262299
Device Name Instant-View® hCG Combo II Cassette Test
Applicant
Alfa Scientific Designs, Inc.
13200 Gregg St.
Powat,  CA  92064
Applicant Contact Michael Chien
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/07/2026
Decision Date 09/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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