Microbiology · 510(k) · 2019
FluChip-8G Influenza A+B Assay
InDevR, Inc.. Cleared by FDA on 22 April 2019 under submission K182513, product code OZE (influenza a and influenza b multiplex nucleic acid assay). What FDA's record says, in FDA's words.
Device record · K182513
- Device. FluChip-8G Influenza A+B AssayDEVICE
- Company. InDevR, Inc.COMPANY
- Decision. 22 April 2019, 510(k), substantially equivalent (traditional review); received 12 September 2018DECISION
- Panel. MicrobiologyPANEL
- Product code. OZE, Influenza A And Influenza B Multiplex Nucleic Acid AssayCODE
- Regulation. 21 CFR 866.3980, Class IIREG
- Source. FDA database entry · decision document (4 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non- seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health […]
The product code's definition, from FDA's classification record. An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5 reports filed against devices carrying product code OZE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
22 March 2025 · Malfunction · ID NOW INFLUENZA A/B 2.0 (24T) · ABBOTT DIAGNOSTICS SCARBOROUGH, INC. · report 1221359-2025-00119
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW INFLUENZA A/B 2.0 ASSAY PERFORMED ON (B)(6) 2025 ON A NASAL SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS PREGNANT AND SHOWING FLU-LIKE SYMPTOMS [FEVER, COUGH, SORE THROAT, CHILLS FOR THREE (3) DAYS, LUNG PAIN, AND PAIN WHEN BREATHING]. DUE TO THE PATIENT¿S FEVER, AND TO RULE OUT PNEUMONIA OR HEART CARDIOPULMONARY, AN X-RAY WAS PERFORMED WHICH SHOWED NO INDICATION OF PNEUMONIA OR HEART CARDIOPULMONARY. THE FOLLOWING DAY, (B)(6) […]
10 March 2025 · Injury · ID NOW INFLUENZA A/B 2.0 (24T) · ABBOTT DIAGNOSTICS SCARBOROUGH, INC. · report 1221359-2025-00087
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW INFLUENZA A/B 2.0 ASSAY PERFORMED ON (B)(6) 2025 ON A NASAL SAMPLE. THE PATIENT WAS SENT HOME WITHOUT TREATMENT. THE PATIENT WAS REPORTED TO HAVE STARTED EXPERIENCING SYMPTOMS THAT DAY, AND THEY WORSENED FOLLOWING THE OFFICE VISIT. FOUR HOURS LATER, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE CONFIRMATION PCR (UNKNOWN PLATFORM) TESTING WAS PERFORMED GENERATING A POSITIVE RESULT. THE PATIENT WAS REPORTED TO BE EXPERIENCING THE […]
1 March 2024 · Malfunction · ID NOW INFLUENZA A/B 2.0 (24T) · ABBOTT DIAGNOSTICS SCARBOROUGH, INC. · report 1221359-2024-00233
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW INFLUENZA A/B ASSAY PERFORMED ON AN UNKNOWN DATE. THE CUSTOMER REPORTED THAT THE PATIENT WAS SENT HOME AND AFTER FEW DAYS HAD A CARDIAC ARREST AT HOME AND DIED. THE POSTMORTEM REPORT CONFIRMED THAT THE PATIENT WAS NOT FLU B POSITIVE. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
13 February 2023 · Malfunction · ACCULA FLU A / FLU B TEST · MESA BIOTECH · report 3013022608-2023-00374
CUSTOMER REPORTED FALSE NEGATIVE. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 866.3980.
10 May 2019 · Malfunction · SEKISUI DIAGNOSTICS SILARIS FLU PCR · MESABIOTECH, INC. · report MW5086579
SEKISUI PRODUCT: SILARIS, REF # 1027 BY MESABIOTECH, INFLUENZA A AND B PCR. THIS PRODUCT PRODUCES ERRONEOUS AND OR NO RESULTS 40% OF THE RUNS, WHEN DIRECTIONS WERE FOLLOWED IN PACKAGE INSERT AND INSTRUCTION MANUAL BY SEKISUI. THIS HAS BEEN REPORTED TO SEKISUI DIAGNOSTICS AND THEY HAVE REPORTED IT TO MESABIOTECH. ALL SEKISUI TEST KITS AND DOCK STATIONS TO RUN THE INFLUENZA A AND B TESTS HAVE BEEN RETURNED TO SEKISUI DIAGNOSTICS. SEKISUI IS AWARE OF THE RESULTING ISSUES WITH THIS MACHINE AND […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OZE, in Microbiology, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
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