Solid Phase Simul Trac Vitamin B12

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

510(k) Number

K822728 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What clinical setting is the Solid Phase Simul Trac Vitamin B12 intended for use in?

  This device is specifically designed for use in clinical chemistry laboratories to measure Vitamin B12 levels in patient samples. It employs a solid-phase radioassay technique for precise quantification, ensuring accurate diagnostic results in a controlled laboratory environment.

• Is the Solid Phase Simul Trac Vitamin B12 kit reusable, or is it meant for single-use only?

  The Solid Phase Simul Trac Vitamin B12 is supplied as a single-use diagnostic kit. This design ensures consistency in results and reduces the risk of cross-contamination, which is critical for accurate Vitamin B12 measurements in patient samples.

• What type of regulatory clearance does this device hold, and how does that affect its use?

  This device holds FDA 510(k) clearance under product code CGN, classified under regulation 862.1295, with a decision code of SESE (Substantially Equivalent). This means it has been determined to be substantially equivalent to a legally marketed device in terms of safety and effectiveness, allowing it to be legally marketed and used in clinical chemistry laboratories for measuring Vitamin B12 levels.

• Are there any special storage instructions for the Solid Phase Simul Trac Vitamin B12 kit?

  The Solid Phase Simul Trac Vitamin B12 kit must be stored according to the manufacturer’s instructions to maintain its integrity until use. Proper storage ensures the accuracy and reliability of the assay results, as environmental conditions can affect the stability of the components in the kit.

• Can this device be used in an MRI environment, or is it restricted to non-MRI settings?

  The Solid Phase Simul Trac Vitamin B12 is explicitly designed for use in non-MRI environments. This restriction is likely due to the presence of radioactive materials or other components that could interfere with MRI compatibility, so it should not be used in areas where MRI scans are performed.