Alere NMP22 Test Kit
by Abbott Diagnostics Scarborough, Inc.
PMA P940035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP940035 | Date2 Jul 1996 | 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- Withdrawn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
- Full name
- Alere NMP22 Test
- Trade Name
- NMP22 BladderChek Test
- Generic Name
- System, test, tumor marker, for detection of bladder cancer
- PMA Number
- FDA Product Code
- NAH
- Device Class
- Class III
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Alere NMP22 Test Kit is an enzyme immunoassay (EIA) system designed for the in vitro quantitative determination of nuclear matrix protein 22 (NMP22) in stabilized voided urine. Classified as a tumor marker detection system, it aids in the evaluation of bladder cancer risk by measuring NMP22 levels, a biomarker associated with urothelial carcinoma.
This test is supplied as a single-use, in vitro diagnostic device intended for use in clinical laboratories or point-of-care settings. The kit requires stabilized urine samples and is regulated under FDA Premarket Approval (PMA) with approval number P940035. Sterility and proper storage conditions are critical to maintaining assay performance, as outlined in the accompanying instructions.
Other devices from Abbott Diagnostics Scarborough, Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical setting or environment is the Alere NMP22 Test intended for use in, and why is this important?
The Alere NMP22 Test is designed for use in clinical laboratories or point-of-care settings. This distinction is important because point-of-care testing allows for quicker results, which can be critical in monitoring bladder cancer risk, while clinical laboratories may offer additional validation or batch processing for larger volumes of samples. The test requires stabilized voided urine, ensuring consistency in sample integrity regardless of where it is performed.
Is the Alere NMP22 Test single-use or reusable, and what does this mean for workflow and cost management?
The Alere NMP22 Test is a single-use device, meaning each kit is intended for one test only. This design reduces the risk of cross-contamination and ensures accurate, consistent results per sample. For workflow, this means each test requires a new kit, which may impact inventory management and cost considerations, but it also simplifies sterilization and maintenance processes since reuse is not applicable.
How should the Alere NMP22 Test be stored, and why is this critical for its performance?
The Alere NMP22 Test must be stored under conditions outlined in the accompanying instructions to maintain assay performance. While the exact storage details are not provided here, proper storage—typically involving temperature control and protection from light or moisture—is critical because enzymes and reagents in the test kit can degrade if exposed to improper conditions. This degradation could lead to inaccurate NMP22 measurements, potentially affecting bladder cancer risk evaluations.
What is the regulatory pathway for the Alere NMP22 Test, and what does this imply for its use in clinical practice?
The Alere NMP22 Test follows the FDA Premarket Approval (PMA) pathway, indicated by approval number P940035. This pathway is typically reserved for higher-risk devices, implying that the test has undergone rigorous evaluation to ensure its safety and effectiveness for detecting NMP22 levels in urine as a tumor marker for bladder cancer. Clinicians and laboratories using this test can rely on its regulatory approval as evidence of its validated performance for its intended purpose.