510(k) K231525

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack by Ortho Clinical Diagnostics — Product Code NIG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 9, 2023
Date Received: May 26, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device Class: Class II
Regulation Number: 866.6010
Review Panel: IM
Submission Type

An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods.

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K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
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K020566 — FUJIREBIO DIAGNOSTICS CA 19-9 RIA (May 9, 2002)