QuikStrip DipScan X Multidrug Screening Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990325 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 QuikStrip DipScan X Multidrug Screening Device is an enzyme immunoassay system designed for the qualitative detection of multiple drugs in biological specimens. It employs a dipstick-based format to identify substances such as amphetamines and other controlled substances, aiding in clinical toxicology assessments.
This device is intended for single-use in laboratory or clinical settings and requires no sterilization beyond its pre-packaged, ready-to-use configuration. It is classified as a Class II medical device under FDA regulations (862.3100) and has received FDA 510(k) clearance (K990325) as substantially equivalent to a predicate device. The device is supplied as a disposable test kit and must be stored according to manufacturer instructions to maintain integrity.
Frequently asked questions
What types of biological specimens can the QuikStrip DipScan X be used to test for drug presence?
The QuikStrip DipScan X Multidrug Screening Device is designed for qualitative detection of multiple drugs in biological specimens, though the exact specimen types (e.g., urine, blood, saliva) are not explicitly listed in the provided data. It is an enzyme immunoassay system with a dipstick format, commonly used in clinical toxicology for urine testing. Always refer to the manufacturer’s instructions for use for the full list of approved specimen types.
Is the QuikStrip DipScan X Multidrug Screening Device reusable, or is it intended for single-use only?
The device is explicitly described as a single-use disposable test kit. It comes pre-packaged and ready-to-use, eliminating the need for sterilization or reprocessing. This design ensures consistency and reduces the risk of contamination or cross-sample contamination.
How should the QuikStrip DipScan X be stored to maintain its integrity and performance?
The device must be stored according to the manufacturer’s instructions to preserve its integrity. While the exact storage conditions (e.g., temperature, humidity) are not detailed in the provided data, typical enzyme immunoassay devices like this require protection from extreme temperatures, moisture, and direct light. Always check the included packaging or Syntron Bioresearch’s documentation for precise storage guidelines.
What controlled substances or drugs does the QuikStrip DipScan X specifically detect?
The device is designed for the qualitative detection of multiple drugs, including amphetamines and other controlled substances, as noted in the description. The exact list of detectable substances is not provided in the data, but the device’s classification under OpenFDA’s drug categories (e.g., amphetamine, cocaine, opioids) suggests it covers common drugs of abuse. For a complete list, refer to the manufacturer’s instructions or technical documentation.
What is the regulatory pathway for the QuikStrip DipScan X, and how was its equivalence determined?
The QuikStrip DipScan X received FDA 510(k) clearance (K990325) under the Traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device. The decision was made by the FDA’s Texas (TX) Advisory Committee under the Clinical Toxicology specialty, confirming it meets regulatory standards for Class II enzyme immunoassay devices. The clearance number and classification (862.3100) further validate its compliance.
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: Quikstrip Dipscan X Multidrug Screening Device, QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE… - FDA.report, PDF K990325 - Quikstrip Dipscan X Multidrug Screening Device, FDA Browser - Cleared 510 (K) - QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING ..., Quikstrip Dipscan X Multidrug Screening Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990325 | Class II | Active |
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Manufacturer
- Manufacturer
- Syntron Bioresearch, Inc.
Sources (1)
- FDA 510(k) K990325 24 fields · synced Sep 19, 2026