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# Hitachi Allergy Testing Instrument Cleared
- URL: https://www.fdaweb.com/hitachi-allergy-testing-instrument-cleared/
- Published: 2019-03-28T12:00:00.000Z
- Updated: 2026-09-15T01:16:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143733

FDA has cleared a Hitachi Chemical Diagnostics 510(k) for its new high capacity allergy testing instrument, Optigen AP 3600\. The device delivers increased throughput and “true walk-away time” compared with its current device, the company says, adding that it can process up to 100 panels, or as many as 3,600 individual allergen results, in a day.

The assay platform also provides medical professionals with a front-line screening approach for panel allergy diagnosis, Hitachi says. It features an on-board operating system; bi-directional (laboratory information system interface; and internal barcode scanners for sample and result identification. “An internal controller, traceable to an international standard, automatically verifies instrument performance prior to each sample analysis, greatly reducing preanalytical process times,” Hitachi says.