Lumipulse G CA19-9-N

Q: What is the product code of K200997?

The FDA product code is NIG – System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.

FDA 510(k) K200997 · Fujirebio Diagnostics,Inc.

Substantially Equivalent

510(k) numberK200997

Submission

Device name: Lumipulse G CA19-9-N
Applicant: Fujirebio Diagnostics,Inc.
Malvern, PA, US
Received: April 16, 2020
Decision date: May 14, 2020
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NIG – System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.6010
Specialty: Immunology

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…

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Questions and answers

When was Lumipulse G CA19-9-N cleared by the FDA?

Lumipulse G CA19-9-N (K200997) received a 510(k) decision of Substantially Equivalent on May 14, 2020, 28 days after the submission was received.

What is the product code of K200997?

The FDA product code is NIG – System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.