VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
FDA 510(k) K231525 · Ortho Clinical Diagnostics
Submission
- Device name
- VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
- Applicant
- Ortho Clinical Diagnostics
Bridgend, GB - Received
- May 26, 2023
- Decision date
- August 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K253528 | Atellica IM CA 19-9 IINIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/10/2026SE |
| 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 |
| K023239 | Aia-Pack Ca 19-9NIG · Traditional | Tosoh Corp. | 12/23/2002SE |
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Questions and answers
When was VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack cleared by the FDA?
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) received a 510(k) decision of Substantially Equivalent on August 9, 2023, 75 days after the submission was received.
What is the product code of K231525?
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.