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# Boston Cell Standards IHControls Panel Cleared
- URL: https://www.fdaweb.com/boston-cell-standards-ihcontrols-panel-cleared/
- Published: 2022-10-06T12:00:00.000Z
- Updated: 2026-09-14T18:02:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152912

FDA has cleared a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers. IHControls is intended to ensure that all immunohistochemistry (IHC) tests, on all patient samples, are performed correctly, according to the company. “Any variation in the IHC reagents, instrument, or protocol can affect the test result,” it says. “IHControls detect these perturbations in a highly sensitive manner because, for the first time, the control concentration is consistently matched to the assay.”