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EMIT-ST Serum Phenobarbital Calibrator

by Syva Co. 510(k)

Active United States

510(k) K811622

Overview

The EMIT-ST Serum Phenobarbital Calibrator is a drug-specific calibrator designed for use with the EMIT (Enzyme-Multiplied Immunoassay Technique) system. It provides standardized reference values for phenobarbital assays in serum samples, ensuring accurate quantitative measurement of drug concentrations in clinical toxicology testing.

This calibrator is intended for in vitro diagnostic use within clinical toxicology laboratories. Supplied as a single-use reagent, it requires no special storage conditions beyond refrigeration and is classified under FDA product code DLJ. The device received a Substantially Equivalent (SESE) determination under FDA 510(k) clearance K811622, dated June 25, 1981, and falls under regulation 862.3200.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811622 Date25 Jun 1981ClearedStatusActive

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
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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

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Questions

  • What is the primary purpose of the EMIT-ST Serum Phenobarbital Calibrator in a clinical toxicology lab?

    The EMIT-ST Serum Phenobarbital Calibrator is designed to provide standardized reference values for phenobarbital assays in serum samples. It ensures accurate quantitative measurement of phenobarbital concentrations, which is critical for reliable clinical toxicology testing, particularly in cases involving drug monitoring or overdose evaluation.

  • How should the EMIT-ST Serum Phenobarbital Calibrator be stored, and is it intended for single-use?

    The calibrator requires no special storage conditions beyond refrigeration, making it easy to maintain. It is supplied as a single-use reagent, meaning each unit is intended for one assay to ensure accuracy and prevent cross-contamination.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    The EMIT-ST Serum Phenobarbital Calibrator received a Substantially Equivalent (SESE) determination under the FDA’s 510(k) clearance process (K811622), dated June 25, 1981. This classification means the device was deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for in vitro diagnostic use in clinical toxicology laboratories.

  • Is this calibrator compatible with any specific diagnostic system, and what type of samples does it analyze?

    The EMIT-ST Serum Phenobarbital Calibrator is specifically designed for use with the EMIT (Enzyme-Multiplied Immunoassay Technique) system, a widely used method in clinical toxicology. It is intended for serum samples only, providing precise calibration for phenobarbital assays to support accurate drug concentration measurements.