Immulite/Immulite 1000 AFP and Immulite 2000/IMMULITE 2500 AFP
by Siemens Healthcare Diagnostics, Inc.
PMA P010007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP010007 | Date9 Nov 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- PMA Number
- FDA Product Code
- LOK
- Device Class
- Class III
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Immulite/Immulite 1000 AFP and Immulite 2000/Immulite 2500 AFP are in vitro diagnostic kits designed for the quantitative measurement of alpha-fetoprotein (AFP). These devices are classified as Class III medical devices and are intended for use with the Immulite Analyzer and Immulite 2000 Analyzer, respectively, to detect AFP levels in human serum, maternal serum, or amniotic fluid.
The kits are supplied for serial measurements in patients with nonseminomatous testicular cancer or for gestational screening between weeks 15 and 20, used alongside ultrasonography or amniography to aid in detecting fetal open neural tube defects. They are approved for use in the United States under a Premarket Approval (PMA) and are intended for single-use in clinical laboratory settings. Sterility and regulatory compliance are ensured through the PMA authorization process.
Other devices from Siemens Healthcare Diagnostics
Questions
AI-generated answers, 18 Sep 2026
What specific patient populations or clinical scenarios are these AFP test kits designed to support?
These kits are designed for two primary clinical scenarios: first, serial measurements of alpha-fetoprotein (AFP) in human serum to aid in managing patients with nonseminomatous testicular cancer; second, measuring AFP in maternal serum or amniotic fluid during gestational weeks 15 through 20, used alongside ultrasonography or amniography to help detect fetal open neural tube defects.
Are these test kits intended for single-use or reusable in clinical settings?
The Immulite/Immulite 1000 AFP and Immulite 2000/Immulite 2500 AFP kits are explicitly intended for single-use in clinical laboratory settings. This ensures sterility and regulatory compliance as part of their Premarket Approval (PMA) authorization.
What types of biological samples can these kits analyze, and how are they supplied?
These kits are designed to quantitatively measure AFP in human serum, maternal serum, or amniotic fluid. They are supplied as in vitro diagnostic kits and must be used with the Immulite Analyzer (for Immulite 1000 AFP) or the Immulite 2000 Analyzer (for Immulite 2000/2500 AFP). The kits are not individually packaged for standalone use but are components of the analyzer system.
What regulatory pathway was followed for approval of these AFP test kits?
These kits were approved under a Premarket Approval (PMA) process by the FDA, which is the regulatory pathway for Class III medical devices. The approval (PMA number P010007) ensures compliance with stringent standards for safety and effectiveness, particularly for diagnostic tests used in critical clinical scenarios like cancer management and prenatal screening.