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FDA PMA

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

PMA Number: P190031 · 2026-05-15

ApplicantVentana Medical Systems, Inc.
Decision Date2026-05-15
PMA NumberP190031
Product CodeNYQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is a medical device manufactured by Ventana Medical Systems, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-15 under PMA number P190031. The device is classified under FDA product code NYQ. It was reviewed by the PA advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is a medical device that received FDA Premarket Approval (PMA) on 2026-05-15. It is manufactured by Ventana Medical Systems, Inc.. The PMA number is P190031.

When did Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer receive FDA PMA approval?

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer received FDA PMA approval on 2026-05-15, under approval number P190031.

What company makes Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is manufactured by Ventana Medical Systems, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

The FDA product code for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is NYQ.

What FDA device class is Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is classified as Class III by the FDA.

Other Devices by Ventana Medical Systems, Inc.

PMA P990081SYSTEM, TEST, HER-2/NEU, IHC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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