What is FDA product code OCC?

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.

Immunology & Microbiology › Serological ReagentsRespiratory Virus Panel Nucleic Acid Assay System

Panther Fusion®

Name: Panther Fusion®
Brand: Panther Fusion®

Panther Fusion AdV/hMPV/RV is a multiplex real-time PCR assay for qualitative detection and differentiation of adenovirus, human metapneumovirus and rhinovirus nucleic acids in…

Registry build 21.09.26

Panther Fusion AdV/hMPV/RV is a multiplex real-time PCR assay for qualitative detection and differentiation of adenovirus, human metapneumovirus and rhinovirus nucleic acids in nasopharyngeal swab specimens. The assay runs on Hologic’s Panther Fusion molecular diagnostic system.

The listed family also includes assay kits, controls and specimen lysis tubes. Those are distinct products supporting the platform workflow; the filed description names the respiratory-virus assay itself.

Listed Item

The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).

Multiplex Testing

The assay uses a single multiplex PCR workflow to identify its three named viral targets from a nasopharyngeal specimen. Its result distinguishes among adenovirus, human metapneumovirus and rhinovirus nucleic acid detection.

The Panther Fusion instrument is the processing platform, while the assay kit supplies test-specific reagents. The family’s controls and lysis tubes are separate consumables, not interchangeable with the assay kit.

1manufacturer

4catalogue numbers in this listing

4510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OCC
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for Panther Fusion®
Listed by	Hologic, Inc., United States
FDA product code	OCC
Device type	Respiratory Virus Panel Nucleic Acid Assay System
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K171963
Record published	2017-11-08
Record revised	2023-12-18 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Panther Fusion®
Catalogue number	Size	Status
FLU A B RSV CTRLS, PANTHER FUSION, IVD		In distribution
SPECIMEN LYSIS TUBES, IVD		In distribution
AMR CTRLS, PANTHER FUSION, IVD		In distribution
AMR KIT, PANTHER FUSION, 96T, IVD		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prodesse	Hologic, Inc.	4
Solana	Diagnostic Hybrids, Inc.	2
Alere™ i Influenza A & B Control Swab Kit	Alere Scarborough, Inc.	1
Silaris RSV Supplemental Pack	Mesa Biotech, Inc.	1
Alere i RSV Control Swab Kit	Alere Scarborough, Inc.	1
ID NOW Influenza A & B 2 Control Swab Kit	Alere Scarborough, Inc.	1
Xpert Xpress Flu/RSV	Cepheid	1
ID NOW Influenza A & B Control Swab Kit	Alere Scarborough, Inc.	1
Simplexa™ Flu A/B & RSV Direct	DiaSorin Molecular LLC	1
Alere™ i Influenza A & B	Alere Scarborough, Inc.	1
Respiratory Virus Plus (RV+) Amplification Tray	Nanosphere, Inc.	1
Accula Flu A / B Test	Mesa Biotech, Inc.	1

Showing 12 of 39. All products under Respiratory Virus Panel Nucleic Acid Assay System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231017	2023-05-05
K172629	2017-12-04
K171963	2017-09-26
K153219	2015-11-20

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Panther Fusion®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Hologic, Inc.	510(k) number	2019-10-10	Class II	Nonconforming Material/Component	Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient	47 kits

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.