Approval for updating the labeling of unicel dx1 instructions for use, operator's guide, reference manual and onboard system help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance thesafety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warningto caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the unicel dxl 800/600 immunoassay systems and unicel dxc 880i/860i/680i/ 660i synchron access integrated clinical systems.
| Device | ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2013-04-12 |
| Decision Date | 2013-08-20 |
| PMA | P970038 |
| Supplement | S023 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970038 | | Original Filing |
| S045 |
2021-04-19 |
Real-time Process |
| S044 |
2020-09-30 |
Real-time Process |
| S043 |
2020-07-22 |
Real-time Process |
| S042 |
2020-06-23 |
Real-time Process |
| S041 |
2019-12-18 |
Real-time Process |
| S040 |
2019-05-13 |
Real-time Process |
| S039 |
2019-05-02 |
Real-time Process |
| S038 | | |
| S037 |
2018-09-25 |
Real-time Process |
| S036 |
2017-09-28 |
30-day Notice |
| S035 | | |
| S034 |
2017-06-09 |
30-day Notice |
| S033 |
2017-03-22 |
Real-time Process |
| S032 |
2017-01-17 |
30-day Notice |
| S031 |
2015-05-07 |
Real-time Process |
| S030 |
2015-01-27 |
135 Review Track For 30-day Notice |
| S029 |
2014-11-04 |
135 Review Track For 30-day Notice |
| S028 |
2014-08-25 |
Real-time Process |
| S027 |
2014-08-25 |
135 Review Track For 30-day Notice |
| S026 |
2013-12-17 |
Real-time Process |
| S025 |
2013-09-26 |
Special (immediate Track) |
| S024 |
2013-06-13 |
Special (immediate Track) |
| S023 |
2013-04-12 |
Special (immediate Track) |
| S022 |
2013-03-29 |
Real-time Process |
| S021 |
2013-01-23 |
Real-time Process |
| S020 |
2013-01-03 |
30-day Notice |
| S019 | | |
| S018 | | |
| S017 |
2012-10-25 |
Special (immediate Track) |
| S016 |
2012-03-15 |
Special (immediate Track) |
| S015 |
2011-12-23 |
Real-time Process |
| S014 |
2011-01-12 |
Special (immediate Track) |
| S013 |
2011-01-10 |
Special (immediate Track) |
| S012 |
2008-05-27 |
Normal 180 Day Track |
| S011 |
2007-12-19 |
Real-time Process |
| S010 |
2007-05-14 |
30-day Notice |
| S009 |
2007-05-16 |
Normal 180 Day Track |
| S008 |
2006-04-10 |
Real-time Process |
| S007 |
2002-12-20 |
Real-time Process |
| S006 |
2002-10-07 |
Real-time Process |
| S005 |
2002-08-19 |
Normal 180 Day Track |
| S004 |
1999-08-27 |
Normal 180 Day Track |
| S003 |
1999-05-14 |
Normal 180 Day Track |
| S002 |
1999-04-27 |
Normal 180 Day Track |
| S001 |
1998-07-23 |
Normal 180 Day Track |
NIH GUDID Devices