Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and Tdm Performance Verifiers I, II and III

• • Ongoing Z-1833-2025 FDA Class II ·initiated 24 Apr 2025

  transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

• • Terminated Z-1887-2017 FDA Class II ·initiated 21 Feb 2017

  Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.

• • Terminated Z-0173-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005

  Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.

510(k) Number

K043386 ↗

FDA Product Code

LEH

Device Class

Class II

Regulation

21 CFR Part 862.3950

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Sofia 2 SARS Antigen+ FIA

  Class II

  FDA 510(k) K254264 Active Cleared 4 Sep 2026

• Sofia Influenza A+B FIA

  Class II

  FDA 510(k) K254262 Active Cleared 4 Sep 2026

• Vitros Immunodiagnostic Products Cortisol Assay

  Class II

  FDA 510(k) K983990 Active Cleared 29 Dec 1998

• Vitros Chemistry Products Caffn Reagent Kit and Tdm Performance Verifiers I, II and III

  Class II

  FDA 510(k) K042520 Active Cleared 30 Nov 2004

• Vitros Immunodiagnostic Products 25-Oh Vitamin D Total Reagent Pack, Vitamin D Total Calibrators

  Class II

  FDA 510(k) K121608 Active Cleared 15 Feb 2013

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