Identity
- Trade Name
- Abbott RealTime IDH1 FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P170041 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Medical Genetics FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Abbott RealTime IDH1 Assay is an in vitro polymerase chain reaction (PCR) system for the qualitative detection of single nucleotide variants (SNVs) in the IDH1 gene. It identifies five specific mutations (R132C, R132H, R132G, R132S, and R132L) in DNA extracted from human blood (EDTA) or bone marrow (EDTA), aiding in the classification of acute myeloid leukemia (AML).
This assay is designed for use with the Abbott m2000rt System and is intended for prescription use only. It is supplied as a single-use diagnostic test, with no regulatory indication of sterility or MRI safety requirements. Authorized under FDA PMA (P170041), it is classified as a Class III device under OpenFDA (product code: OWD).
Frequently asked questions
What specific mutations in the IDH1 gene does the Abbott RealTime IDH1 Assay detect, and how does this help in diagnosing AML?
The Abbott RealTime IDH1 Assay detects five specific single nucleotide variants (SNVs) in the IDH1 gene: R132C, R132H, R132G, R132S, and R132L. These mutations are associated with acute myeloid leukemia (AML), and identifying them aids in classifying the subtype of AML, particularly for patients who may be candidates for targeted therapy like TIBSOVO® (ivosidenib). The assay is designed to work with DNA extracted from EDTA-preserved blood or bone marrow samples.
Is the Abbott RealTime IDH1 Assay intended for single-use or reusable applications, and what system is required for its operation?
The Abbott RealTime IDH1 Assay is supplied as a single-use diagnostic test, meaning each test kit is designed for one-time use only. It is specifically intended for use with the Abbott m2000rt System, a molecular diagnostics platform that automates the PCR process for qualitative detection of the IDH1 mutations.
What types of sample collection methods are compatible with the Abbott RealTime IDH1 Assay, and are there any special handling requirements?
The assay is compatible with DNA extracted from human blood or bone marrow samples collected in EDTA tubes. No additional sterility or special handling requirements are specified beyond standard molecular diagnostics protocols, as it is not labeled as sterile and is intended for in vitro use only.
How is the Abbott RealTime IDH1 Assay classified under regulatory frameworks, and what does this mean for its use in clinical settings?
The Abbott RealTime IDH1 Assay is classified as a Class III device under the OpenFDA system and is authorized under an FDA Premarket Approval (PMA) application (P170041). This classification indicates it is subject to stringent regulatory oversight due to its role in diagnosing genetic mutations linked to AML, ensuring its performance and safety are thoroughly validated before clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P170041 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P170041 24 fields · synced Sep 18, 2026