Synelisa SM ABS/RNP-SM ABS

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

510(k) Number

K930141 ↗

FDA Product Code

LKP

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Elias U.S.A., Inc. →

• What clinical conditions is this test primarily used to evaluate, and how does it help in diagnosis?

  The Synelisa SM ABS/RNP-SM ABS test is designed to detect and measure anti-Smith (anti-Sm) antibodies in serum or plasma, which are markers associated with connective tissue diseases. It is particularly useful in the evaluation of systemic lupus erythematosus (SLE), a chronic autoimmune condition, helping clinicians identify the presence of these antibodies to support diagnostic or monitoring decisions.

• Is this test kit single-use, and if so, what are the storage requirements?

  Yes, the Synelisa SM ABS/RNP-SM ABS is supplied as a single-use kit, meaning each kit is intended for one test procedure only. Storage is straightforward—it requires refrigeration between 2°C and 8°C, with no additional special conditions needed. This ensures stability and reliability for professional use in CLIA-certified clinical laboratories.

• Who is this test intended for, and what type of facility should use it?

  This test is intended for professional use only in clinical laboratories that meet Clinical Laboratory Improvement Amendments (CLIA) standards. It is designed for in vitro diagnostic use, meaning it should only be performed by trained personnel in accredited settings where proper handling and interpretation of results are ensured.

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

  The Synelisa SM ABS/RNP-SM ABS received FDA 510(k) clearance under the Traditional 510(k) Review pathway, specifically classified as substantially equivalent to a predicate device. This means the device was evaluated by the FDA’s Immunology (IM) advisory committee and deemed comparable to existing, cleared technologies, ensuring it meets established safety and performance standards for clinical use in the U.S.

• Does this kit include components to verify test accuracy, and how does that work?

  Yes, the kit includes both antigen and control components, which are essential for ensuring accurate and reliable test results. The control component helps validate the test procedure by confirming that the reagents are functioning correctly, while the antigen component specifically targets anti-Smith antibodies in the sample, allowing for precise detection and measurement.