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FDA PMA

Prostrate cancer genes nucleic acid amplification test system

PMA Number: P100033 · 2020-07-21

ApplicantGen-Probe Incorporated
Decision Date2020-07-21
PMA NumberP100033
Product CodeOYM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Prostrate cancer genes nucleic acid amplification test system is the device name listed in this FDA PMA record. The listed applicant is Gen-Probe Incorporated. It received FDA Premarket Approval (PMA) on 2020-07-21 under PMA number P100033. The device is classified under FDA product code OYM. 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 valid scientific evidence providing reasonable assurance of safety and effectiveness. 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 Prostrate cancer genes nucleic acid amplification test system?

Prostrate cancer genes nucleic acid amplification test system is a medical device that received FDA Premarket Approval (PMA) on 2020-07-21. The listed applicant is Gen-Probe Incorporated. The PMA number is P100033.

When did Prostrate cancer genes nucleic acid amplification test system receive FDA PMA approval?

Prostrate cancer genes nucleic acid amplification test system received FDA PMA approval on 2020-07-21, under PMA number P100033.

Who is the listed applicant for Prostrate cancer genes nucleic acid amplification test system?

The FDA PMA record lists Gen-Probe Incorporated as the applicant. This does not by itself establish the device manufacturer.

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 valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Prostrate cancer genes nucleic acid amplification test system?

The FDA product code for Prostrate cancer genes nucleic acid amplification test system is OYM.

What FDA device class is Prostrate cancer genes nucleic acid amplification test system?

Prostrate cancer genes nucleic acid amplification test system is classified as Class III by the FDA.

Other records listing Gen-Probe Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P120007Kit, rna detection, human papillomavirusPMA P100042Kit, rna detection, human papillomavirusPMA P020011Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Official Source

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

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