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

Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge

Name: Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Brand: Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge

Catalogue number 20-006-024, listed by Luminex Corporation, United States, under Respiratory Virus Panel Nucleic Acid Assay System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

8recalls on this code

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 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Listed by	Luminex Corporation, 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	Contract manufacturer, Remanufacturer, Complaint-file establishment, Manufacturer
510(k)	K143653
Record published	2019-12-05
Record revised	2023-12-18 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Catalogue number	Size	Status
20-006-024		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Panther Fusion®	Hologic, Inc.	4
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

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
K161220	2016-08-02

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Luminex Corporation	510(k) number	2020-10-30	Class II	Device Design	Potential for a false-negative result.	38,990
Luminex Corporation	510(k) number	2018-12-10	Class II	Component design/selection	No results/incorrect results due to failure of the hybridization heater.	1 system

Recalls

6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-10-30	Class II	Device Design	Potential for a false-negative result.	24,338
2020-10-30	Class II	Device Design	Potential for a false-negative result.	36,416
2020-10-30	Class II	Device Design	Potential for a false-negative result.	165
2020-10-30	Class II	Device Design	Potential for a false-negative result.	17,110
2020-10-30	Class II	Device Design	Potential for a false-negative result.	1,261
2013-10-10	Class II	Nonconforming Material/Component	Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.	780 units	2015-06-16

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.