NCS RA Latex Test

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K841146 ↗

FDA Product Code

DHR

Device Class

Class II

Regulation

21 CFR Part 866.5775

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Kultsure (Catalogue No. M250)

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• Kultsure (Catalogue No. M240)

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• Kultsure

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  FDA 510(k) K870231 Active Cleared 4 Feb 1987

See all devices from Ncs Diagnostics, Inc. →

• What clinical setting is the NCS RA Latex Test designed for, and how is it used in practice?

  The NCS RA Latex Test is designed for use in clinical immunology settings, specifically within laboratories. It employs latex agglutination technology to qualitatively detect rheumatoid factor (RF) antibodies in human serum or plasma, which are markers associated with rheumatoid arthritis (RA). Clinicians use this single-use reagent kit to help identify the presence of RF, aiding in the diagnosis or monitoring of autoimmune conditions affecting synovial joints.

• Is the NCS RA Latex Test intended for single-use, and if so, what does that mean for handling and storage?

  Yes, the NCS RA Latex Test is supplied as a single-use reagent kit, meaning each kit is designed for one-time use only. This eliminates the need for reprocessing or sterilization between uses. Proper handling follows standard aseptic techniques, and storage conditions—including expiration dates—are detailed in the instructions for use provided with the kit.

• What regulatory pathway was followed for the FDA clearance of the NCS RA Latex Test, and what does that mean for its classification?

  The NCS RA Latex Test received FDA clearance through a 510(k) submission, classified as a Class II medical device under the DHR (Diagnostic, Hematology, Rheumatology) product code. The clearance was granted as substantially equivalent to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously cleared product. This classification reflects its role as an in vitro diagnostic device for qualitative detection of rheumatoid factor.

• How is the test supplied, and are there any special handling requirements beyond standard laboratory practices?

  The NCS RA Latex Test is supplied as a single-use reagent kit, requiring no additional special handling beyond standard aseptic techniques typically used in laboratory settings. The kit is designed for qualitative detection of rheumatoid factor antibodies in human serum or plasma, so no additional preparation or sterilization steps are specified beyond those already in place for in vitro diagnostics.