Skip to content

EMIT Lidocaine Control

by Syva Co. 510(k)

Active United States

510(k) K772167

Overview

The EMIT Lidocaine Control is a drug-specific calibrator designed for use in clinical toxicology assays. It serves as a reference standard to ensure accuracy and consistency in measuring lidocaine concentrations within laboratory testing systems, particularly those utilizing the EMIT (Enzyme Multiplied Immunoassay Technique). This calibrator is categorized under drug-specific calibrators and is intended for use in toxicology and therapeutic drug monitoring applications.

Supplied as a single-use reagent, the EMIT Lidocaine Control is regulated under FDA 510(k) clearance (K772167) and falls under product code DLJ, classified as a Class II device. It is intended for use in clinical laboratory settings and requires adherence to standard laboratory protocols for storage and handling. The device is not sterile and is not intended for direct patient use. No additional regulatory markings or MRI safety considerations are specified.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772167 Date22 Nov 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DLJ
Device Class
Class II
Regulation
21 CFR Part 862.3200
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Syva Co.

See all devices from Syva Co. →

Questions

  • What is the EMIT Lidocaine Control used for?

    The EMIT Lidocaine Control is a drug-specific calibrator designed to ensure accuracy and consistency in measuring lidocaine concentrations within clinical toxicology assays. It is specifically intended for use with the EMIT (Enzyme Multiplied Immunoassay Technique) testing systems, helping laboratories maintain reliable results for therapeutic drug monitoring and toxicology applications.

  • Is the EMIT Lidocaine Control sterile?

    No, the EMIT Lidocaine Control is not sterile. It is supplied as a single-use reagent and is intended for use in laboratory settings only, not for direct patient application. Sterility is not a requirement for this type of calibrator, as it is designed for in vitro diagnostic use.

  • How is the EMIT Lidocaine Control supplied?

    The EMIT Lidocaine Control is supplied as a single-use reagent. This means each unit is intended for one-time use in a laboratory setting, ensuring consistency and preventing cross-contamination between tests. The packaging is designed to maintain the integrity of the calibrator until use.

  • What regulatory approval does the EMIT Lidocaine Control have?

    The EMIT Lidocaine Control is regulated under FDA 510(k) clearance with the clearance number K772167. It is classified as a Class II device under product code DLJ and is intended for use in clinical laboratory settings. The device is not intended for direct patient use.

  • What storage and handling requirements apply to the EMIT Lidocaine Control?

    The EMIT Lidocaine Control must be stored and handled according to standard laboratory protocols. Since it is a single-use reagent, it should be kept in a clean, dry environment away from direct sunlight and extreme temperatures. Always follow manufacturer guidelines for storage to ensure the calibrator remains effective until use.