EMIT D.A.U. Propoxyphene Assay
by Syva Co. 510(k)
Active
510(k) K850920
Overview
The EMIT D.A.U. Propoxyphene Assay is an enzyme immunoassay designed for the qualitative detection of propoxyphene in biological specimens. As classified under product code JXN, it falls within the category of toxicology devices, specifically for drugs of abuse testing. This assay leverages enzyme-linked immunoassay technology to identify propoxyphene metabolites, aiding in clinical toxicology evaluations.
This assay is supplied as a reagent kit for in vitro diagnostic use, intended for laboratory settings. It is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. The device was cleared under the FDA’s 510(k) pathway (K850920) as substantially equivalent to a predicate device, with regulatory classification as a Class 2 device under regulation 862.3700. No MRI safety or reusable components are indicated in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850920 | Date2 Apr 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3700
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT D.A.U. Propoxyphene Assay used for?
The EMIT D.A.U. Propoxyphene Assay is an enzyme immunoassay designed specifically for the qualitative detection of propoxyphene and its metabolites in biological specimens, such as urine or serum. It is used in clinical toxicology evaluations to identify propoxyphene presence, aiding in patient assessment for drug exposure or overdose.
How is the EMIT Propoxyphene Assay supplied, and is it reusable?
The assay is supplied as a reagent kit for in vitro diagnostic use, intended exclusively for laboratory settings. It is designed for single-use only, meaning each kit is meant to be used once per test. No sterilization beyond the manufacturer-provided packaging is required, as the kit is pre-sterilized and sealed.
What regulatory pathway was used for FDA clearance of this device?
The EMIT D.A.U. Propoxyphene Assay was cleared under the FDA’s 510(k) pathway, specifically through a traditional review process. It was determined to be substantially equivalent to a predicate device, earning a classification as a Class 2 medical device under regulation 862.3700. This classification reflects its role as a toxicology device for drugs of abuse testing.
Are there multiple models or sizes available for this assay?
The EMIT D.A.U. Propoxyphene Assay is associated with multiple registration numbers, indicating potential variations in batch or lot sizes, but the core assay remains consistent in its design and purpose. These registration numbers do not imply distinct models or sizes but rather reflect regulatory tracking for different production batches or distribution channels. Always refer to the manufacturer’s documentation for specific batch details.
How should the EMIT Propoxyphene Assay be stored?
Storage instructions are not explicitly detailed in the provided data, but standard practice for enzyme immunoassay kits typically requires storage at controlled room temperature (15–30°C) or refrigerated (2–8°C), depending on the manufacturer’s guidelines. The kit should be kept in its original, unopened packaging to maintain sterility and integrity until use. Always consult the included instructions for precise storage recommendations.