Abbott Phenobarbital Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123271 FDA 510(k)
- FDA Product Code
- DLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3660 FDA 510(k)
- Regulation Number
- 862.3660 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Abbott Phenobarbital Assay is an in vitro diagnostic enzyme immunoassay for the quantitative measurement of phenobarbital in serum or plasma. It employs a particle-enhanced turbidimetric inhibition immunoassay (PETIIA) to detect and quantify drug levels, supporting clinical toxicology assessments.
This assay is designed for use on the ARCHITECT c8000 clinical chemistry analyzer and is supplied as a single-use reagent kit. Authorized under FDA 510(k) clearance (K123271) and classified under IVDD, it adheres to regulatory requirements outlined in 21 CFR 862.3660. Sterility and performance are validated for clinical laboratory settings, with no MRI safety considerations.
Frequently asked questions
What clinical applications is the Abbott Phenobarbital Assay designed to support in a laboratory setting?
The assay is specifically designed for clinical toxicology assessments, enabling quantitative measurement of phenobarbital levels in serum or plasma. This helps clinicians monitor drug concentrations in patients undergoing phenobarbital therapy, managing overdoses, or evaluating toxicity, ensuring precise dosing and patient safety.
How is the Abbott Phenobarbital Assay supplied, and is it intended for single-use?
The assay is supplied as a single-use reagent kit, meaning each kit is intended for one analytical run on the ARCHITECT c8000 clinical chemistry analyzer. This design ensures sterility and consistency per regulatory validation, preventing cross-contamination and maintaining accuracy for each test.
Which analyzer systems is this assay compatible with, and does it require any special handling?
The assay is exclusively designed for use on the Abbott ARCHITECT c8000 clinical chemistry analyzer. No additional handling is required beyond following the manufacturer’s instructions for reagent preparation and analyzer programming, as it is validated for this system under regulatory standards.
Are there any storage or sterility considerations for this assay kit?
The assay is sterile and validated for clinical laboratory use, meaning it is packaged to prevent contamination and must be stored according to the manufacturer’s guidelines (typically refrigerated or at room temperature, as specified in the kit documentation). Single-use design eliminates the need for reprocessing, ensuring reliability and compliance with regulatory requirements.
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: ABBOTT PHENOBARBITAL ASSAY (K123271) — FDA 510(k) | Innolitics, PDF 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ..., ABBOTT PHENOBARBITAL ASSAY 510(k) K123271 - FDA.report
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 | K123271 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K123271 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026