FDA product code PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

PQD is the FDA product code for blood specimen collection convenience kit (excludes hiv). It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. Devices under PQD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PQD devices, 1 initiated in the last five years.

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Classification

Recalls for PQD devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-03-16.

Frequently asked questions

What is FDA product code PQD?

PQD is the FDA product code for blood specimen collection convenience kit (excludes hiv). It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.

What device class is PQD?

Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k) exempt.

Have PQD devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-03-16.

Next steps

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