Rapidone-Buprenorphine Test
510(k) K060760
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060760 | Date7 Aug 2006 | 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- Withdrawn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
- DJG
- Device class
- Class II
- Regulation
- 21 CFR Part 862.3650
- Advisory committee
- Clinical Toxicology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The RapidOne Buprenorphine Test is an enzyme immunoassay designed for the qualitative detection of buprenorphine in biological specimens. As classified under FDA regulation 21 CFR §862.3650, this device falls under the category of opiate test systems and is intended for use in clinical toxicology assessments. It employs immunochromatographic technology to provide rapid, qualitative results for buprenorphine presence, aiding in the identification of opioid-related substances in patient samples.
This test is supplied as a single-use, lateral flow immunochromatographic device, requiring no specialized equipment beyond standard laboratory reagents. It is intended for use in clinical settings, including toxicology laboratories, and is regulated under FDA 510(k) clearance (K060760) as a Class II device. The device is not sterile and must be handled according to manufacturer guidelines to ensure accurate and reliable results. Storage conditions and shelf life are specified in the accompanying instructions for use.
Other devices from American Bio Medica Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the RapidOne Buprenorphine Test used for?
The RapidOne Buprenorphine Test is designed for the qualitative detection of buprenorphine in biological specimens, such as urine or blood. It aids clinical toxicology assessments by identifying the presence of this opioid-related substance, helping clinicians evaluate potential opioid exposure or misuse in patients.
How is the RapidOne Buprenorphine Test supplied and used?
The test is supplied as a single-use, lateral flow immunochromatographic device. No specialized equipment is required beyond standard laboratory reagents. It provides rapid, qualitative results within minutes, making it suitable for point-of-care or laboratory settings where quick opioid screening is needed.
Is the RapidOne Buprenorphine Test sterile?
No, the RapidOne Buprenorphine Test is not sterile. It is intended for in vitro diagnostic use only and must be handled according to the manufacturer’s guidelines to ensure accurate and reliable results. Proper aseptic techniques should be followed when preparing samples to prevent contamination.
Can the RapidOne Buprenorphine Test be reused?
No, the RapidOne Buprenorphine Test is designed for single-use only. Each device is intended for one test procedure, after which it should be discarded. Reusing the test could compromise accuracy and introduce cross-contamination risks.
What storage conditions and shelf life apply to the RapidOne Buprenorphine Test?
Storage conditions and shelf life are detailed in the accompanying instructions for use. Generally, such immunochromatographic tests require storage at controlled room temperature (typically 2–30°C) and protection from moisture or direct sunlight. Always refer to the manufacturer’s guidelines for precise storage instructions and expiration dates.