(23 days)
Not Found
No
The description focuses on isothermal nucleic acid amplification technology and fluorescence detection, with no mention of AI or ML in the device operation or result interpretation.
No
The device is an in vitro diagnostic test used to detect and discriminate specific viral and bacterial RNA/DNA, aiding in diagnosis rather than providing therapy.
Yes
This device is explicitly stated as an "in vitro diagnostic test" for detecting and discriminating influenza A and B viral RNA and for the qualitative detection of Streptococcus pyogenes, with the intention to “aid in the rapid diagnosis.” This clearly identifies its purpose as diagnostic.
No
The device description clearly outlines multiple hardware components, including a Sample Receiver, Test Base, Transfer Cartridge, and the Alere™ i Instrument itself, which performs heating, mixing, and detection. The software is part of a larger system that includes physical components for sample handling and analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use/Indications for Use: Both the Alere™ i Influenza A & B and Alere™ i Strep A sections clearly state they are "rapid molecular in vitro diagnostic test[s]".
- Purpose: The tests are designed to detect and discriminate viral or bacterial RNA/DNA in human specimens (nasal and throat swabs) to aid in the diagnosis of specific infections. This is the core function of an in vitro diagnostic device.
- Specimen Type: The tests are performed on biological specimens taken from the human body (nasal and throat swabs).
- Testing Location: While it can be used at the point of care, the description also mentions use in a medical laboratory, which is a common setting for IVD testing.
- Technology: The use of isothermal nucleic acid amplification technology to detect specific genetic material is a common method employed by molecular IVDs.
The description aligns perfectly with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Alere™ i Influenza A & B: The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2012-2013 influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Alere™ i Strep A: Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections. All negative test results should be confirmed by bacterial culture because negative results do not prection with Group A Streptococcus and should not be used as the sole basis for treatment.
Product codes (comma separated list FDA assigned to the subject device)
OOI, OCC, OZE, PGX
Device Description
Alere™ i Influenza A & B is a rapid, instrument-based isothermal tests for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs collected from patients presenting with signs and symptoms of respiratory infection. Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. Both Alere™ i Influenza A & B and Alere™ i Strep A Systems utilize isothermal nucleic acid amplification technology and are comprised of:
- Sample Receiver – single use, disposable containing the elution buffer
- Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
- Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test Base, and
- Alere™ i Instrument – repeat use reader
The reaction tubes in the Alere™ i Influenza A & B Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.
The reaction tubes in the Alere™ i Strep A Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.
Both assays are performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis (for Alere™ i Strep A) and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.
Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal swabs (for Influenza A & B), throat swab specimens (for Strep A)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use, in a medical laboratory or point of care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation studies performed demonstrated that Alere™ i Influenza A & B and Alere™ i Strep A assay functionality remains unchanged due to this change. The results of the software validation studies performed with the Alere™ i Instrument, demonstrate the Alere™ i Influenza A & B and Alere™ i Strep A tests performed on the Alere™ i Instrument containing modified software is substantially equivalent to the current legally marketed device, Alere™ i Influenza A & B and Alere™ i Strep A performed on the Alere™ i Instrument.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2015
ALERE SCARBOROUGH, INC. ANGELA DRYSDALE VP REGULATORY & CLINICAL AFFAIRS-INFECTIOUS DISEASE 10 SOUTHGATE ROAD SCARBOROUGH ME 04074
Re: K151690 Trade/Device Name: Alere™ i Instrument. Alere™ i Influenza A & B, Alere™ i Strep A Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: II Product Code: OOI, OCC, OZE, PGX Dated: June 22, 2015 Received: June 23, 2015
Dear Ms. Drysdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar-S 2015.07.16 13:25:50 -04'00' For
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151690
Device Name Alere™ i Instrument, Alere™ i Influenza A & B, Alere™ i Strep A
Indications for Use (Describe)
Alere™ i Influenza A & B:
The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2012-2013 influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Alere™ i Strep A:
Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
All negative test results should be confirmed by bacterial culture because negative results do not prection with Group A Streptococcus and should not be used as the sole basis for treatment.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K151690
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drysdale (207) 730-5737 (Office) (207) 730-5767 (FAX) angela.drysdale@alere.com (email)
DATE PREPARED
7/14/2015
TRADE NAME
Alere™ i Instrument Alere™ i Influenza A & B Alere ™ i Strep A
COMMON NAME
Alere™ i flu, Alere™ i, Alere™ Influenza A & B Alere™ i Strep, Alere™ i, Alere™ Strep A
REGULATION NAME
Instrumentation for Clinical Multiplex Test Systems (per 21 CFR 862.2570) Respiratory Viral Panel Multiplex Nucleic Acid Assay (per 21 CFR 866.3980) Groups A, C and G Beta Hemolytic Streptococcus Nucleic acid Amplification System (per 21 CFR 866.2680)
CLASSIFICATION
Class II
PRODUCT CODES
001, OCC, OZE, PGX
PANEL Microbiology (83)
PREDICATE DEVICES
Alere™ i Influenza A & B, K141520 Alere ™ i Strep A, K141757
5
DEVICE DESCRIPTION
Alere™ i Influenza A & B is a rapid, instrument-based isothermal tests for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs collected from patients presenting with signs and symptoms of respiratory infection. Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. Both Alere™ i Influenza A & B and Alere™ i Strep A Systems utilize isothermal nucleic acid amplification technology and are comprised of:
- . Sample Receiver – single use, disposable containing the elution buffer
- . Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
- Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test Base, and ●
- Alere™ i Instrument – repeat use reader
The reaction tubes in the Alere™ i Influenza A & B Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.
The reaction tubes in the Alere™ i Strep A Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.
Both assays are performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis (for Alere™ i Strep A) and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.
Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.
INTENDED USE
The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
6
Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimed from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
TECHNOLOGICAL CHARACTERISTICS
Both assays are rapid, instrument-based, molecular in vitro diagnostic tests utilizing isothermal nucleic acid amplification technology for the qualitative detection of influenza A and B viral RNA or Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid.
DEVICE COMPARISON
The purpose of this submission is due to a modification of the software contained on the Alere™ i Instrument, there have been no changes to the Alere™ i Influenza A & B or Alere™ i Strep A tests. To enable launch of the Alere™ i Strep A test on the Alere™ i platform, a modification to the software was required to allow the user to run both the Alere™ i Influenza A & B and Alere™ i Strep A assays on the same instrument.
Alere™ i Influenza A & B incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared Alere™ i Influenza A & B test.
| Parameter | Alere™ i Influenza A & B
(with software modification) | Alere™ i Influenza A & B (K141520) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| FDA Product Code | OCC,OZE, OOI | Same |
| Assay Target | Influenza A, Influenza B | Same |
| Intended Use | The Alere™ i Influenza A & B assay
performed on the Alere™ i Instrument is
a rapid molecular in vitro diagnostic test
utilizing an isothermal nucleic acid
amplification technology for the
qualitative detection and discrimination
of influenza A and B viral RNA in nasal
swabs from patients with signs and
symptoms of respiratory infection. It is
intended for use as an aid in the
differential diagnosis of influenza A and
B viral infections in humans in
conjunction with clinical and
epidemiological risk factors. The assay is
not intended to detect the presence of | Same |
7
| Parameter | Alere™ i Influenza A & B
(with software modification) | Alere™ i Influenza A & B (K141520) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | influenza C virus. | |
| | Negative results do not preclude
influenza virus infection and should not
be used as the sole basis for diagnosis,
treatment or other patient management
decisions. | |
| | Performance characteristics for influenza
A were established during the 2012-
2013 influenza season when influenza
A/H3 and A/H1N1 pandemic were the
predominant influenza A viruses in
circulation. When other influenza A
viruses are emerging, performance
characteristics may vary. | |
| | If infection with a novel influenza A virus
is suspected based on current clinical
and epidemiological screening criteria
recommended by public health
authorities, specimens should be
collected with appropriate infection
control precautions for novel virulent
Influenza viruses and sent to state or
local health department for testing. Viral
culture should not be attempted in these
cases unless a BSL 3+ facility is available
to receive and culture specimens. | |
| Intended Environment
for Use | Professional use, in a medical laboratory
or point of care | Same |
| Instrumentation | Alere™ i Instrument | Same |
| Self-Contained System | Integrated PC, Software, and Touch
Screen Display | Same |
| Automated Assay | Yes. Sample preparation, amplification,
detection, and result interpretation. | Same |
| Assay Information
Sample Type | Nasal Swab | Same |
| Influenza A Viral Target | PB2 segment | Same |
| Influenza B Viral Target | PA segment | Same |
| Technology | Isothermal nucleic acid amplification for
detecting the presence/absence of viral
RNA in clinical specimens | Same |
| Detection Method | Assay uses different reporter dyes for
each target | Same |
| Internal Control | Yes | Same |
| Result Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result | in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes , Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment, | Same |
| Instrumentation | Alere™ i Instrument | Same |
| Assay Information | | |
| Sample Type | Throat Swab | Same |
| Target Analyte | Group A Streptococcus ( Streptococcus pyogenes ) | Same |
| Technology | Isothermal nucleic acid amplification | Same |
| Internal Control | Yes | Same |
| Result Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result |