Abbott Carbamazepine Assay (K123518)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123518 FDA 510(k)
- FDA Product Code
- KLT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3645 FDA 510(k)
- Regulation Number
- 862.3645 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Abbott Carbamazepine Assay is an enzyme immunoassay for in vitro diagnostic use, designed to measure carbamazepine concentrations in human serum or plasma. It employs a homogeneous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) method to provide quantitative results, supporting clinical toxicology assessments.
This assay is supplied as a reagent kit intended for use on ARCHITECT cSystems platforms. It is classified as a Class II device under FDA regulation 21 CFR 862.3645, with a product code of KLT. The device is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. No MRI safety or reusable components are specified in the regulatory data.
Frequently asked questions
What clinical area does the Abbott Carbamazepine Assay support, and how does it function in that context?
The Abbott Carbamazepine Assay supports clinical toxicology assessments by measuring carbamazepine concentrations in human serum or plasma. It uses a homogeneous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) method to provide quantitative results, helping clinicians monitor drug levels for therapeutic management or toxicity evaluation in patients.
Is this assay compatible with any specific laboratory systems, and how is it supplied?
Yes, the Abbott Carbamazepine Assay is designed exclusively for use on Abbott’s ARCHITECT cSystems platforms. It is supplied as a single-use reagent kit, meaning each kit is intended for one test run and does not require additional sterilization beyond the manufacturer’s sealed packaging.
Can this assay be reused, or does it require special handling beyond opening the packaging?
The assay is explicitly intended for single-use only, as stated in the regulatory data. No reusable components are specified, and no additional sterilization is required beyond what the manufacturer provides in the sealed packaging. This ensures consistency and safety for each test.
What regulatory pathway was followed for this device, and what classification does it hold?
The Abbott Carbamazepine Assay was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type, and was determined to be substantially equivalent to a predicate device. It is classified as a Class II device under FDA regulation 21 CFR 862.3645, with a product code of KLT, indicating its intended use in clinical toxicology.
Are there any special storage or handling instructions mentioned for this assay beyond standard laboratory practices?
The regulatory data does not specify special storage instructions beyond what would be typical for an enzyme immunoassay reagent kit. However, since it is single-use and supplied in sealed packaging, it should be stored according to the manufacturer’s instructions (likely refrigerated or at room temperature, as is standard for immunoassays) to maintain integrity until 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. Sources consulted: PDF 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ..., ABBOTT CARBAMAZEPINE ASSAY (K123518) — FDA 510(k) | Innolitics, Abbott Carbamazepine Assay - Beudamed
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123518 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA 510(k) K123518 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026