Ion Torrent A30320

• FDA PMA P160045 decided 22 Jun 2017 Active
• FDA GUDID UDI-DI 10190302000888 listed 28 Jun 2018 Listed

• 4 recalls, same reason

  • Terminated Z-1706-2020 FDA Class II ·initiated 16 Mar 2020
  • Terminated Z-1705-2020 FDA Class II ·initiated 16 Mar 2020
  • Terminated Z-1707-2020 FDA Class II ·initiated 16 Mar 2020
  • Terminated Z-1704-2020 FDA Class II ·initiated 16 Mar 2020

  Extended Expiration Date prior to clearance

• • Terminated Z-1480-2018 FDA Class II ·initiated 8 Feb 2018

  The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.

• • Terminated Z-1279-2018 FDA Class II ·initiated 4 Dec 2017

  The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.

1. 22 Jun 2017 Approved FDA PMA P160045
2. 4 Dec 2017 Recall initiated FDA recalls Z-1279-2018
3. 8 Feb 2018 Recall initiated FDA recalls Z-1480-2018
4. 28 Jun 2018 Listed FDA GUDID 10190302000888
5. 16 Mar 2020 Recall initiated FDA recalls Z-1706-2020
6. 16 Mar 2020 Recall initiated FDA recalls Z-1705-2020
7. 16 Mar 2020 Recall initiated FDA recalls Z-1707-2020
8. 16 Mar 2020 Recall initiated FDA recalls Z-1704-2020

Trade name

Ion Torrent

Generic name

PCR/NAT negative control IVD

Model / reference

A30320

Primary DI / UDI-DI

10190302000888

PMA number

P160045 ↗

FDA product code

PQP

GMDN term

PCR/NAT negative control IVD

Device class

Class III

GUDID distribution status

In Commercial Distribution

Category: PCR/NAT negative control IVD

Other devices filed under FDA product code PQP (Next generation sequencing oncology panel, somatic or germline variant detection system).

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• PGDx elio tissue complete CDx by Personal Genome Diagnostics, Inc.
• ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) by Pillar Biosciences
• Guardant360 Liquid CDx by Guardant Health, Inc.
• Oncomine Dx Express Test by Life Technologies Corporation
• xT CDx by Tempus Labs, Inc.
• Signatera CDx by Natera, Inc.
• Praxis Extended RAS Panel by Illumina, Inc.
• Guardant360 CDx by Guardant Health, Inc.

• Oncomine ™ Dx Express Test

  Class II

  FDA 510(k) K260827 Active Cleared 15 Oct 2026

• Oncomine™ Dx Express Test DNA Control A50834

  Class III

  FDA PMA P240040 Active Approved 2 Jul 2025 GUDID on market

• Oncomine™ Dx Express Test RNA Control A50835

  Class III

  FDA PMA P240040 Active Approved 2 Jul 2025 GUDID on market

• Oncomine™ Dx Express Test NTC Control A50836

  Class III

  FDA PMA P240040 Active Approved 2 Jul 2025 GUDID on market

See all devices from Life Technologies Limited →