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FDA PMA

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

PMA Number: P000012 · 2016-08-04

ApplicantRoche Molecular Systems, Inc.
Decision Date2016-08-04
PMA NumberP000012
Product CodeMZP
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA Premarket Approval (PMA) on 2016-08-04 under PMA number P000012. The device is classified under FDA product code MZP. It was reviewed by the MI advisory panel. This device is classified as Class II by the FDA. Class III devices subject to special controls, in addition to general controls. These devices typically require premarket notification (510(k)). PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of M. It is regulated under 21 CFR Part 8. 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 Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is a medical device that received FDA Premarket Approval (PMA) on 2016-08-04. It is manufactured by Roche Molecular Systems, Inc.. The PMA number is P000012.

When did Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus receive FDA PMA approval?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus received FDA PMA approval on 2016-08-04, under approval number P000012.

What company makes Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is manufactured by Roche Molecular 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 Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

The FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is MZP.

What FDA device class is Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is classified as Class II by the FDA.

Related Clinical Trials

NCT06099795 Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 RECRUITING NCT03112044 Lung Transplant HCV, Pilot Study ACTIVE_NOT_RECRUITING NCT05333679 Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) COMPLETED NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT06877026 FibroScan-Reproducibility and Repeatability Study COMPLETED NCT05188573 EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients WITHDRAWN

Related PubMed Literature

PMID: 40706113 RNA aptamer-packaged virus-like particles for label-free, rapid, and on-site fluorescence detection of malachite green in aquatic products. Biosensors & bioelectronics (2025) PMID: 40246728 [Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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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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