Rads
510(k) K011054
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011054 | Date30 Jul 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DIO
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3250
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The RADS is an enzyme immunoassay device designed for the qualitative detection of cocaine and its metabolites in biological specimens. It falls under the category of immunoassay systems, specifically for clinical toxicology applications, enabling rapid screening in laboratory settings.
This device is supplied as a single-use kit and requires no special storage conditions beyond those specified in the manufacturer’s instructions. It is classified as a Class II medical device under FDA regulations (862.3250) and has received FDA 510(k) clearance (K011054) as substantially equivalent to a predicate device. The kit is intended for use in clinical laboratories and adheres to standard immunoassay protocols.
Questions
AI-generated answers, 19 Sep 2026
What types of biological specimens can the RADS detect cocaine and its metabolites in, and how is it used in a clinical setting?
The RADS is designed for the qualitative detection of cocaine and its metabolites in biological specimens, specifically within clinical toxicology applications. It is an enzyme immunoassay device intended for rapid screening in laboratory settings. While the exact specimen types (e.g., urine, blood, saliva) aren’t detailed here, the device follows standard immunoassay protocols typically used for such testing, allowing laboratories to screen patients for cocaine exposure or overdose. It is not a point-of-care test but requires laboratory processing.
Is the RADS device single-use, and if so, does it require any special handling or storage beyond standard laboratory conditions?
Yes, the RADS is supplied as a single-use kit, meaning each kit is intended for one test cycle only. It does not require special storage conditions beyond what the manufacturer specifies in its instructions. This simplifies inventory management and reduces the risk of cross-contamination, as each kit is discarded after use. Standard laboratory storage practices (e.g., controlled temperature, dry environment) should suffice.
What regulatory pathway was followed for the RADS, and how does this affect its use in clinical laboratories?
The RADS received FDA 510(k) clearance (K011054) under the Traditional pathway, demonstrating it is substantially equivalent to a predicate device. This clearance confirms its compliance with FDA standards for Class II medical devices (category 862.3250), which includes enzyme immunoassay systems for clinical toxicology. Clinicians and laboratories can rely on this approval to ensure the device meets regulatory requirements for detecting cocaine and its metabolites in biological specimens, though adherence to manufacturer instructions and laboratory protocols remains critical.
Are there different models or sizes available for the RADS, or is it a standardized kit for all applications?
The provided data does not specify multiple models or sizes for the RADS, implying it is likely offered as a standardized single-use kit for general clinical toxicology use. The device is classified under product code DIO (Diagnostic Immunoassay Systems) and is intended for broad application in detecting cocaine and metabolites. If specific variations (e.g., sensitivity thresholds or specimen types) are needed, they would typically be addressed through manufacturer documentation or additional product lines not referenced here.