Cx(TM) Barbiturates(BARB) Reagent for Synchron CX Syst

• • Terminated Z-1799-2020 FDA Class II ·initiated 12 Jun 2019

  The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.

510(k) Number

K944075 ↗

FDA Product Code

DIS

Device Class

Class II

Regulation

21 CFR Part 862.3150

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Beckman Instruments, Inc. →

• What clinical setting is this reagent intended for, and how does it function?

  The CX(TM) Barbiturates (BARB) Reagent is designed specifically for clinical toxicology settings, where barbiturate drug detection is critical. It functions as an enzyme immunoassay within the Synchron CX system, enabling quantitative measurement of barbiturate concentrations in patient samples. This makes it ideal for laboratories analyzing drug levels in cases of overdose, poisoning, or routine toxicology screening.

• How is the reagent supplied, and is it reusable?

  The reagent is supplied as a single-use cartridge containing 250 tests, meaning each cartridge is intended for one-time use in the Synchron CX system. This design ensures consistency and reduces the risk of cross-contamination, which is particularly important in toxicology testing where accuracy is paramount.

• Are there specific storage instructions provided for this reagent?

  The provided data does not include explicit storage conditions for the CX(TM) Barbiturates Reagent. However, since it is a single-use cartridge for clinical diagnostic use, it should be stored according to standard laboratory protocols for immunoassay reagents—typically in a cool, dry place, protected from light and extreme temperatures. Always verify the manufacturer’s latest guidelines for optimal performance.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  The CX(TM) Barbiturates Reagent was cleared through the FDA’s 510(k) Traditional pathway, demonstrating substantial equivalence to a predicate device. It is classified under FDA regulation 862.3150 as a Class II device, which requires special controls due to its role in quantitative clinical toxicology testing. The clearance was granted by the FDA’s TX (Toxicology) Advisory Committee in 1994.