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Abusign DOA4

FDA 510(k)

Class II (US FDA 510(k))

510(k) K943439

by Princeton Biomeditech Corp.

Identifiers

510(k) Number
K943439 FDA 510(k)
FDA Product Code
DKZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3100 FDA 510(k)
Regulation Number
862.3100 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Abusign DOA4 is an enzyme immunoassay device designed for the qualitative detection of drugs of abuse, including amphetamines, in human urine specimens. It functions as an in vitro diagnostic test to identify the presence or absence of amphetamine metabolites, aiding clinical toxicology assessments.

This device is intended for single-use in professional settings, such as clinical laboratories or point-of-care environments. Supplied as a ready-to-use kit, it requires no additional sterilization and is classified under FDA regulation 862.3100 as a Class II device with a traditional 510(k) clearance (K943439). The test is not MRI-compatible and must be stored according to manufacturer instructions to maintain integrity.

Frequently asked questions

What clinical setting is the Abusign DOA4 intended for use in, and why is this important?

The Abusign DOA4 is designed for use in professional settings such as clinical laboratories or point-of-care environments. This is important because it ensures the test is conducted in controlled environments where proper handling, storage, and interpretation of results are maintained, reducing the risk of errors that could occur in non-professional settings.

Is the Abusign DOA4 device reusable, and if not, what does this mean for cost management in a clinical setting?

No, the Abusign DOA4 is intended for single-use only. This means each test kit is designed to be used once and then discarded, which helps prevent cross-contamination and ensures accurate results. Clinically, this simplifies inventory management and reduces the risk of device-related errors, though it may impact budgeting for frequent testing due to the need for repeated purchases.

How should the Abusign DOA4 be stored, and why is proper storage critical for this device?

The Abusign DOA4 must be stored according to the manufacturer’s instructions to maintain its integrity. Proper storage is critical because it preserves the stability and accuracy of the test kit, ensuring reliable detection of amphetamine metabolites in urine specimens. Improper storage could lead to false results or device failure.

What type of regulatory clearance does the Abusign DOA4 hold, and what does this imply about its safety and effectiveness?

The Abusign DOA4 holds a traditional 510(k) clearance (K943439) from the FDA, classified as a Class II device under regulation 862.3100. This implies that it has been determined to be substantially equivalent to a legally marketed device and meets FDA standards for safety and effectiveness. The clearance also indicates it has undergone review by the FDA’s advisory committee for Clinical Toxicology, ensuring its suitability for detecting amphetamine metabolites in clinical toxicology assessments.

Can the Abusign DOA4 be used in conjunction with MRI equipment, and why is this limitation important?

No, the Abusign DOA4 is explicitly stated as not MRI-compatible. This limitation is important because MRI environments involve strong magnetic fields and radiofrequency interference, which could potentially damage or alter the performance of non-MRI-compatible devices. Since this test is used for qualitative detection in urine specimens, ensuring it is not exposed to MRI environments prevents interference with its functionality and maintains accurate results.

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: Abusign (Tm) Doa 4, Doa, Thc/Opi/Coc/Amp or Met, Biosign (Tm) Doa 4 ..., Abusign (tm) Doa 4, Doa, Thc/opi/coc/amp Or Met, Biosign (tm) Doa 4 ..., PDF K943439 - Abusign Doa4, Abusign Doa4 - Beudamed, Princeton BioMedite… — 72 FDA 510 (k)s · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA 510(k) K943439 24 fields · synced Sep 19, 2026