FDA product code PLS: Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

PLS is the FDA product code for immunohistochemistry assay, antibody, programmed death-ligand 1. It is a Class III device, reviewed by the Pathology panel. Devices under PLS reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 2 recalls for PLS devices, 1 initiated in the last five years.

Definition

The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.

Classification

Recalls for PLS devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-18.

Frequently asked questions

What is FDA product code PLS?

PLS is the FDA product code for immunohistochemistry assay, antibody, programmed death-ligand 1. It is a Class III device, reviewed by the Pathology panel.

What device class is PLS?

Class III. Typical premarket route: PMA.

Have PLS devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2022-11-18.

Next steps

• Run an FDA pathway report with predicate devices for product code PLS
• Run a recall and safety report across every PLS manufacturer
• Watch product code PLS for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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