Changes being made in the hafp antibody production: 1) use of additional l-glutamine supplement during the production of the coating antibody to the medium that contains nutrients (glucose and glutamine), and setting a recommended minimum concentration of glutamine during the production of the hafp antibodies; and 2) addition of glutamine and glutamate testing of the routine anti-hafp antibody production samples to the presently performed glucose and lactate testing.
| Device | AutoDELFIA hAFP Test System |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | PerkinElmer, Inc. |
| Date Received | 2017-05-11 |
| Decision Date | 2017-06-07 |
| PMA | P970037 |
| Supplement | S010 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PerkinElmer, Inc. 940 Winter Street waltham, MA 02451 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970037 | | Original Filing |
| S012 |
2021-07-15 |
30-day Notice |
| S011 |
2018-08-09 |
30-day Notice |
| S010 |
2017-05-11 |
30-day Notice |
| S009 |
2016-07-27 |
30-day Notice |
| S008 |
2012-05-15 |
30-day Notice |
| S007 |
2011-09-23 |
135 Review Track For 30-day Notice |
| S006 |
2011-06-13 |
30-day Notice |
| S005 |
2011-03-17 |
30-day Notice |
| S004 |
2011-02-02 |
30-day Notice |
| S003 |
2010-03-01 |
Normal 180 Day Track |
| S002 |
2008-09-17 |
Normal 180 Day Track |
| S001 |
2002-10-18 |
Special (immediate Track) |
NIH GUDID Devices