Easy-Test EMIT Ethosuximide Item 16647

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

Full name

Easy-Test Emit(R) Ethosuximide (Eths) Item 16647

510(k) Number

K881607 ↗

FDA Product Code

DLF

Device Class

Class II

Regulation

21 CFR Part 862.3380

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Em Diagnostic Systems, Inc. →

• What clinical setting is this device intended for, and how does it differ from general lab tests?

  The Easy-Test EMIT Ethosuximide is specifically designed for clinical toxicology applications, meaning it is used to detect ethosuximide levels in biological specimens—typically to monitor overdose, poisoning, or therapeutic drug levels in patients. Unlike general lab tests that measure routine biomarkers, this device is tailored for toxicology labs or clinical settings where ethosuximide screening is critical, such as emergency departments or specialized toxicology units.

• Is this test single-use, and if so, why is that important for my lab?

  Yes, the Easy-Test EMIT Ethosuximide is supplied as a single-use diagnostic test, meaning each device is intended for one test only. This design minimizes cross-contamination risk, reduces the need for reprocessing, and aligns with best practices for qualitative immunoassays in toxicology, where accuracy and traceability are paramount. Single-use also simplifies inventory management and disposal protocols.

• What does the FDA’s classification as a Class II device mean for my lab’s use of this test?

  The FDA’s classification of this device as Class II under product code DLF indicates it has undergone a 510(k) premarket notification review (with clearance K881607) to demonstrate substantial equivalence to a legally marketed predicate device. For your lab, this means the device has met FDA standards for safety and effectiveness in clinical toxicology, but it must still be used within its intended purpose—qualitative detection of ethosuximide—and adheres to standard laboratory practices for immunoassays.

• How would I determine if this test is compatible with the biological specimens my lab commonly tests?

  The device is designed for qualitative detection of ethosuximide in biological specimens, though the exact specimen types (e.g., urine, serum, whole blood) aren’t detailed in the data. For compatibility, confirm with the manufacturer whether your lab’s typical specimens (e.g., urine for drug screening) are supported. Since it’s an enzyme immunoassay (EMIT), it’s generally optimized for liquid samples, but always verify against your lab’s standard operating procedures to ensure accuracy.