EMIT 2000 Procainamide Calibrators
by Syva Co. 510(k)
Active
510(k) K922914
Overview
The EMIT 2000 Procainamide Calibrators are enzyme immunoassay devices used for the quantitative measurement of procainamide in clinical specimens. They are substantially equivalent to a predicate device and were cleared through the traditional 510(k) pathway.
These calibrators are intended for use in clinical toxicology settings and are supplied as in vitro diagnostic reagents. They are cleared for commercial distribution under FDA 510(k) K922914, with product code LAR and regulation number 862.3320.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922914 | Date24 Aug 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT 2000 Procainamide Calibrator used for?
The EMIT 2000 Procainamide Calibrator is an enzyme immunoassay device intended for the quantitative measurement of procainamide in clinical specimens, used in clinical toxicology settings to support accurate drug level monitoring.
How is the EMIT 2000 Procainamide Calibrator supplied and is it sterile?
The device is supplied as in vitro diagnostic reagents for use in laboratory testing; sterility is not applicable as it is not a surgical or implantable device but a reagent-based assay system.
Is the EMIT 2000 Procainamide Calibrator single-use or reusable?
As an in vitro diagnostic reagent, the calibrator is intended for single-use in each test run to ensure accuracy and prevent cross-contamination, consistent with standard reagent handling practices.
What regulatory pathway was used for the EMIT 2000 Procainamide Calibrator?
The device was cleared through the traditional 510(k) pathway as substantially equivalent to a predicate device, with FDA clearance under K922914 and product code LAR.