IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY
FDA premarket approval P010050/S008 · decided 2009-06-02
Approval details
- PMA number
- P010050
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2009-05-13
- Decision date
- 2009-06-02
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- APPROVAL FOR REVISIONS TO THE PRODUCT LABELING TO INCLUDE A ¿HOT ZONE CUTOFF¿ UNDER THE INTERPRETATION OF RESULTS SECTION. THIS ¿HOT ZONE CUTOFF¿ ESTABLISHES A LEVEL AT WHICH HIGH HBSAG REACTIVE SAMPLES MAY BE REPORTED AS REACTIVE WITHOUT CONFIRMATORY TESTING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (K213510) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 |
| IMMULITE® 2000 Cortisol (K202826) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| IMMULITE/IMMULITE® 1000 Cortisol (K203270) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |