Fujirebio Diagnostics Ca 19-9 Ria

Q: What is the product code of K020566?

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) K020566 · Fujirebio Diagnostics,Inc.

Substantially Equivalent

510(k) numberK020566

Submission

Device name: Fujirebio Diagnostics Ca 19-9 Ria
Applicant: Fujirebio Diagnostics,Inc.
Malvern, PA, US
Received: February 20, 2002
Decision date: May 9, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 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…

Other 510(k)s with product code NIG

510(k)	Device	Applicant	Decision
K253528	Atellica IM CA 19-9 IINIG · Traditional	Siemens Healthcare Diagnostics, Inc.	08/10/2026SE
K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional	Ortho Clinical Diagnostics	08/09/2023SE
K200997	Lumipulse G CA19-9-NNIG · Special	Fujirebio Diagnostics,Inc.	05/14/2020SE
K191973	Lumpipulse G CA19-9-NNIG · Traditional	Fujirebio Dianostics, Inc.	10/22/2019SE
K100375	Dimension Vista Loci Ca 19-9 Flex Reagent Cartridge, and Dimension LOCI7 Calibrator with…NIG · Traditional	Siemens Healthcare Diagnostics, Inc.	04/06/2011SE
K052889	Vitros Ca 19-9NIG · Traditional	Fujirebio Diagnostics,Inc.	12/20/2005SE
K052000	Architect Ca 19-9XR AssayNIG · Traditional	Fujirebio Diagnostics,Inc.	10/25/2005SE
K033038	Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687…NIG · Traditional	Beckman Coulter, Inc.	12/29/2003SE
K031393	Bayer Advia Centaur Ca 19-9 AssayNIG · Traditional	Bayer Healthcare, LLC	06/24/2003SE
K023240	ST Aia-Pack Ca 19-9NIG · Traditional	Tosoh Corp.	12/23/2002SE

More from Tosoh Corp.

510(k)	Device	Decision
K250925	ADVIA Centaur Cytokeratin Fragment 21-1OVK · Traditional	12/16/2025SE
K242706	Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET · Traditional	05/16/2025SE
K192524	Lumipulse G CA15-3MOI · Traditional	09/04/2020SE
K192380	ST Aia-Pack BNPNBC · Traditional	08/24/2020SE
K200997	Lumipulse G CA19-9-NNIG · Special	05/14/2020SE
K190702	Lumipulse G whole PTHCEW · Traditional	08/30/2019SE
K172713	Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT…PRI · Traditional	12/10/2017SE
K171103	Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional	07/28/2017SE
K163546	Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated	01/13/2017SE
K163534	Lumipulse G FSH-N CalibratorsJIT · Abbreviated	01/13/2017SE

Questions and answers

When was Fujirebio Diagnostics Ca 19-9 Ria cleared by the FDA?

Fujirebio Diagnostics Ca 19-9 Ria (K020566) received a 510(k) decision of Substantially Equivalent on May 9, 2002, 78 days after the submission was received.

What is the product code of K020566?

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.