Aia-Pack Ca 19-9
FDA 510(k) K023239 · Tosoh Corp.
Submission
- Device name
- Aia-Pack Ca 19-9
- Applicant
- Tosoh Corp.
Seymour, CT, US - Received
- September 27, 2002
- Decision date
- December 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
|---|---|---|
| K023240 | ST Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | 07/21/1992SE |
| K913663 | Aia-Pack T-UKHQ · Traditional | 09/30/1991SE |
| K913298 | Aia-Pack Ck-MbJHX · Traditional | 09/27/1991SE |
| K913493 | Aia-Pack FT4CEC · Traditional | 09/10/1991SE |
| K903628 | Aia-Pack IriCFP · Traditional | 09/07/1990SE |
| K901965 | MPR-4A - Micro-Plate ReaderJJQ · Traditional | 05/10/1990SE |
| K901674 | AIA-600 Automated Enzyme Immunoassay SystemKHO · Traditional | 05/02/1990SE |
| K897001 | Tosoh Aia-Pack T3CDP · Traditional | 03/09/1990SE |
| K896982 | Aia-Pack T4KLI · Traditional | 03/09/1990SE |
Questions and answers
When was Aia-Pack Ca 19-9 cleared by the FDA?
Aia-Pack Ca 19-9 (K023239) received a 510(k) decision of Substantially Equivalent on December 23, 2002, 87 days after the submission was received.
What is the product code of K023239?
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.