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.

Alere I RSV Control Swab Kit · Respiratory Virus Panel Nucleic Acid Assay System → Immunology & Microbiology

Name: Alere i RSV Control Swab Kit
Brand: Alere i RSV Control Swab Kit

1manufacturer

1catalogue number

5510(k) clearances naming this product 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 Alere i RSV Control Swab Kit
Listed by	Alere Scarborough, 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
510(k)	K161375
Record published	2016-10-28
Record revised	2023-09-12 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Distribution end date	2020-01-28

Catalogue Numbers

Catalogue numbers for Alere i RSV Control Swab Kit
Catalogue number	Size	Status
435-080		Withdrawn

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
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
K173932	2018-01-26
K171792	2017-09-29
K163266	2016-12-21
K161375	2016-08-18
K151464	2015-07-28

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 Alere i RSV Control Swab Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Abbott Diagnostics Scarborough, Inc.	510(k) number	2025-03-04	Class II	Process change control	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.	178056 eaches (147472 US, 31584 OUS)
Abbott Diagnostics Scarborough, Inc.	510(k) number	2025-03-04	Class II	Process change control	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.	442,296 eaches

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.

Alere I RSV Control Swab Kit