Easy-Test Salicylate (Sal) #16691

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K873425 ↗

FDA Product Code

DKJ

Device Class

Class II

Regulation

21 CFR Part 862.3830

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the Easy-Test Salicylate (Sal) #16691 used for in clinical settings?

  The Easy-Test Salicylate (Sal) #16691 is a colorimetric device designed for the qualitative detection of salicylate levels in biological samples. It provides a rapid visual assessment by producing a color change proportional to salicylate concentration, making it useful in clinical toxicology laboratories for identifying the presence or absence of salicylates in patient samples.

• Is the Easy-Test Salicylate (Sal) #16691 intended for single-use or repeated use?

  The device is explicitly labeled as a single-use diagnostic test, meaning each unit is intended for one-time use only. This ensures accuracy and prevents cross-contamination in clinical toxicology testing.

• What regulatory pathway was followed for FDA clearance of this device?

  The Easy-Test Salicylate (Sal) #16691 received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device under product code DKJ (regulatory number 862.3830). The submission was reviewed by the Clinical Toxicology Advisory Committee and determined to be substantially equivalent to a predicate device.

• Are there any specific storage instructions provided for this device?

  The available data does not specify storage conditions for the Easy-Test Salicylate (Sal) #16691. Clinicians should refer to the manufacturer’s instructions or contact Em Diagnostic Systems for proper storage guidance to maintain test integrity.

• How does the device indicate the presence of salicylates, and what type of samples can it analyze?

  The device works via colorimetric detection, meaning it changes color in proportion to salicylate concentration in biological samples. While the exact sample types (e.g., urine, serum) are not detailed, its clinical toxicology indication suggests it is designed for rapid qualitative screening in settings where salicylate poisoning or overdose may be suspected.