AlloMap Molecular Expression Testing (DEN080007)
by Xdx
De Novo DEN080007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN080007 | Date26 Aug 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Full name
- Allomap Molecular Expression Testing
- De Novo Number
- FDA Product Code
- OJQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1163
- Advisory Committee
- Cardiovascular
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 19 Sep 2026
The AlloMap Molecular Expression Testing is an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) designed for cardiac allograft gene expression profiling. It evaluates molecular markers in blood samples to assess the risk of moderate-to-severe acute cellular rejection in heart transplant patients by quantifying RNA levels of 20 specific genes.
This test is performed in a single laboratory (XDx Laboratories) and requires blood samples drawn from patients, which are processed, packaged, and shipped frozen for analysis. The assay yields a composite score ranging from 0 to 40, aiding clinicians in noninvasive risk stratification. The device is classified under FDA 510(k) clearance (DEN080007) and falls under regulation number 862.1163, with no indication of single-use or reusable status.
Questions
AI-generated answers, 19 Sep 2026
How is the AlloMap Molecular Expression Testing performed, and what type of sample is required from patients?
The AlloMap test is conducted exclusively at Xdx Laboratories, where blood samples are drawn from heart transplant patients. These samples are processed, packaged, and shipped frozen to the lab for analysis. The assay evaluates RNA levels of 20 specific genes in the blood to generate a composite score (ranging 0–40) that helps assess the risk of moderate-to-severe acute cellular rejection. No on-site testing is available—only centralized lab processing is offered.
Is the AlloMap test reusable, or is it designed for single-use only?
The AlloMap Molecular Expression Testing is not described as reusable or single-use in the provided data. Since it involves processing patient blood samples in a centralized lab (Xdx Laboratories) and no mention of device reuse is made, it is implied that each test run is performed on a fresh sample for a single patient assessment. Clarification from the manufacturer would be needed for definitive reuse policies.
What does the AlloMap score range indicate, and how is it used clinically?
The AlloMap test produces a composite score between 0 and 40, derived from quantifying 20 gene markers in blood samples. Clinicians use this score to noninvasively stratify the risk of moderate-to-severe acute cellular rejection in heart transplant patients. Higher scores correlate with increased risk, aiding in treatment decisions without requiring invasive biopsies.
How is the AlloMap test regulated, and what regulatory pathway was followed for its clearance?
The AlloMap Molecular Expression Testing received FDA clearance through a 510(k) pathway (K-number: DEN080007), classified under regulation number 862.1163 and product code OJQ. It was reviewed by the Cardiovascular (CV) advisory committee and cleared post-NSE (Not Substantially Equivalent) with a decision date of August 26, 2008. The test is categorized as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA).