Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System
FDA 510(k) K022288 · Bayer Corp.
510(k) numberK022288
Submission
- Device name
- Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- July 15, 2002
- Decision date
- December 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code LTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/05/2026SE |
| K162378 | FREND PSA PLUS (reagent cartridge)LTJ · Traditional | Nanoentek USA, Inc. | 05/17/2017SE |
| K124056 | Frend Psa Plus (Reagent Cartridge)LTJ · Traditional | Nanoentek, Inc. | 05/29/2013SE |
| K031343 | Tpsa Flex Reagent CartridgeLTJ · Special | Dade Behring, Inc. | 05/15/2003SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | Bayer Diagnostics Corp. | 12/17/2002SE |
| K010550 | Vidas Total Prostate Specific Antigen (Tpsa), Model 30 428LTJ · Traditional | bioMerieux, Inc. | 04/24/2001SE |
| K003963 | Dimension Psa Flex Reagent CartridgeLTJ · Traditional | Dade Behring, Inc. | 02/28/2001SE |
| K002376 | Advia: Centaur and Acs: 180 Cpsa AssayLTJ · Traditional | Bayer Corp. | 10/26/2000SE |
| K003094 | Fastpack Psa Immunoassay, Fastpack AnalyzerLTJ · Special | Qualigen, Inc. | 10/25/2000SE |
| K002313 | Complexed Psa Microtiter ElisaLTJ · Traditional | Oncogene Science, Inc. | 08/30/2000SE |
More from Oncogene Science, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K024062 | Ascensia Breeze Blood Glucose MeterCGA · Traditional | 03/03/2003SE |
| K023944 | Bayer Diagnostics Clinitest Pregnancy TestJHI · Abbreviated | 02/11/2003SE |
| K024017 | Bayer Advia Centaur HER-2/NEU AssayNCW · Traditional | 01/30/2003SE |
| K024234 | Ascensia Glucofacts; Ascensia Glucofacts ProfessionalNBW · Traditional | 01/23/2003SE |
| K023584 | Ascensia Dex 2 Diabetes Care SystemNBW · Special | 11/20/2002SE |
| K020828 | Ca 125 Assay for the Advia Centaur SystemLTK · Traditional | 07/24/2002SE |
| K021428 | Clinitek Atlas Pro 12 Reagent Pak SystemJFY · Traditional | 07/05/2002SE |
| K020806 | ACS:180 & Advia Centaur Afp ImmunoassayLOJ · Special | 03/27/2002SE |
| K013568 | Cea Assay for the Advia Integrated Modular SystemDHX · Traditional | 12/21/2001SE |
| K012337 | Bayer Advia Ims System; C-Reactive Protein SystemDCN · Traditional | 12/06/2001SE |
Questions and answers
When was Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System cleared by the FDA?
Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System (K022288) received a 510(k) decision of Substantially Equivalent on December 17, 2002, 155 days after the submission was received.
What is the product code of K022288?
The FDA product code is LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, a Class II (moderate risk) device regulated under 21 CFR 866.6010.