Acs:Centaur PSA2 Immunoassay
FDA 510(k) K981839 · Chiron Diagnostics Corp.
510(k) numberK981839
Submission
- Device name
- Acs:Centaur PSA2 Immunoassay
- Applicant
- Chiron Diagnostics Corp.
Medfield, MA, US - Received
- May 26, 1998
- Decision date
- August 12, 1998
- 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 |
| K022288 | Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional | Bayer Corp. | 12/17/2002SE |
| 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 |
More from Qualigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992157 | Chiron Diagnostics Acs: 180 Ferritin AssayDBF · Traditional | 08/05/1999SE |
| K991582 | Chiron Diagnostics Acs: 180 FolateCGN · Traditional | 06/30/1999SE |
| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | 06/18/1999SE |
| K982680 | Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayMOI · Traditional | 10/15/1998SE |
| K981478 | Acs:Centaur CeaDHX · Traditional | 08/12/1998SE |
| K981592 | Acs:Centaur AfpLOQ · Traditional | 07/07/1998SE |
| K980528 | Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)MMI · Traditional | 03/03/1998SE |
| K974029 | Acs TobramycinLCR · Traditional | 02/12/1998SE |
| K974325 | Chiron Diagnostics ACS:180 MyoglobinDDR · Traditional | 12/08/1997SE |
| K970695 | ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…MOI · Traditional | 08/08/1997SE |
Questions and answers
When was Acs:Centaur PSA2 Immunoassay cleared by the FDA?
Acs:Centaur PSA2 Immunoassay (K981839) received a 510(k) decision of Substantially Equivalent on August 12, 1998, 78 days after the submission was received.
What is the product code of K981839?
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.