(155 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 description, performance studies, or key metrics. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is an in vitro diagnostic test intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections, not to provide therapy or treatment for a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "a rapid, instrument-based, molecular in vitro diagnostic test" and is "intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections."
No
The device description explicitly lists multiple hardware components, including a Sample Receiver, Test Base, Transfer Cartridge, and the Alere™ i Instrument, which is a repeat-use reader providing heating, mixing, and detection.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Intended Use / Indications for Use: Explicitly states it is an "in vitro diagnostic test" and is "intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: Describes the components and process of testing a biological sample (throat swab specimens) outside of the body to detect specific bacterial nucleic acid. This is the core function of an IVD.
- Clinical Study: The performance study compares the device's results to bacterial culture, a standard diagnostic method, further indicating its use in a diagnostic context.
- Key Metrics: The reporting of sensitivity, specificity, PPV, and NPV are standard metrics used to evaluate the performance of diagnostic tests.
N/A
Intended Use / Indications for Use
Alere™ i Strep A 2 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.
Product codes (comma separated list FDA assigned to the subject device)
PGX, OOI
Device Description
Alere™ i Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Streptococus pyogenes Group A Strep from throat swab specimens. The Alere™ i Strep A 2 System utilizes isothermal nucleic acid amplification technology and is 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 Test Base contain the reagents required for Streptococcus pyogenes Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Streptococcus pyggenes, Group A Strep and fluorescently labeled molecular beacons designed to specifically identify the amplified nucleic acid targets. Alere™ i Strep A 2 is 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. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis 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
throat swab specimens
Indicated Patient Age Range
patients of all ages
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
A total of 981 evaluable throat swab specimens, collected from patients of all ages presenting with symptoms of pharyngitis, were evaluated with Alere™ i Strep A 2, in comparison to bacterial culture.
In this study, two (2) throat swabs were collected from each of 981 evaluable patients. One throat swab from each patient was tested with Alere™ i Strep A 2. The other throat swab was sent to a central laboratory for bacterial culture.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL STUDY
The clinical performance of Alere™ i Strep A 2 was established in a multi-center, prospective clinical study conducted at nine (9) US trial sites in 2017.
A total of 981 evaluable throat swab specimens, collected from patients of all ages presenting with symptoms of pharyngitis, were evaluated with Alere™ i Strep A 2, in comparison to bacterial culture.
The study population included 582 (59.3%) female patients and 399 (40.7%) male patients. No performance differences were noted based on age.
In this study, two (2) throat swabs were collected from each of 981 evaluable patients. One throat swab from each patient was tested with Alere™ i Strep A 2. The other throat swab was sent to a central laboratory for bacterial culture.
Alere™ i Strep A 2 performance, including 95% confidence intervals, versus bacterial culture is provided below.
Alere™ i Strep A 2 Performance vs. Culture (All Age Groups Combined)
Total samples: 981
Alere™ i + / Culture +: 195
Alere™ i + / Culture -: 52
Alere™ i - / Culture +: 3
Alere™ i - / Culture -: 731
ANALYTICAL STUDIES
ANALYTICAL SENSITIVITY: Limit of detection (LOD) was determined.
Alere™ i Strep A 2 limit of detection (LOD or C s), defined as the concentration of Group A Strep that produces positive Alere™ i Strep A 2 results approximately 95% of the time, was identified by evaluating different concentrations of Group A Strep in Alere™ i Strep A 2.
- ATCC 12344: 147 (cells/mL of Elution Buffer), 100% Detected
- ATCC 19615: 25 (cells/mL of Elution Buffer), 95% Detected
REACTIVITY TESTING: The following Group A Strep strains were tested and produced positive reactions at or near the stated assay limit of detection of the Alere™ i Strep A 2 test: ATCC12384, ATCC12202, ATCC12203, ATCC12204, ATCC12365, ATCC14289, ATCC49399, ATCC51339, ATCC700294, ATCC12357, ATCC12385 Loomis, ATCC 12385 Type 4, and Z018.
ANALYTICAL SPECIFICITY (CROSS-REACTIVITY): To determine the analytical specificity of Alere™ i Strep A 2, thirty-four (34) commensal and pathogenic microorganisms (33 bacteria and 1 yeast) that may be present in the throat were tested. All of the following microorganisms and yeast produced negative when tested at a minimum concentration of 2.00 x 10^6 cells/mL of elution buffer. In addition, in silico analysis was performed to determine whether there is any significant homology between Alere™ i Strep A 2 target nucleic acid sequence and the genomes of certain upper respiratory tract microorganisms. None of the organisms maintained genomic sequence that was significantly similar.
INTERFERING SUBSTANCES: The following substances, naturally present in throat swab specimens or that may be artificially introduced into the throat, were evaluated with Alere™ i Strep A 2 at various concentrations and were found not to affect test performance (exceptions noted for mucin, saliva, and Listerine Antiseptic Mouthwash).
REPRODUCIBILITY: A reproducibility study of Alere™ i Strep A 2 was conducted by operators from 3 sites using panels of blind coded specimens containing negative, low positive (~2X the limit of detection), and moderate positive (~3X the limit of detection) Group A Strep bacterial samples. Participants tested multiple samples of each panel member on 5 different days. The percent agreement with expected results for the Group A Strep moderate positive and low positive samples were both 100% (90/90). All of the negative samples (90) generated negative test results. There were no significant differences within run (replicates tested by one operator), between run (five different days), between sites (three sites), or between operators (nine operators).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 195/198 = 98.5% (95% CI = 95.6%, 99.5%)
Specificity: 731/783 = 93.4% (95% CI = 91.4%, 94.9%)
Positive Predictive Value: 195/247 = 78.9% (95% CI = 74.3%, 83.6%)
Negative Predictive Value: 731/734 = 99.6 (95% CI = 98.3%, 99.9%)
Prevalence: 198/981 =20.2% (95% CI = 17.8%, 22.8%)
Initial invalid rate: 0.9% (9/985) (95% Cl: 0.5%, 1.7%)
Invalid rate after repeat testing: 0.4% (4/985) (95% CI: 0.2%, 1.0%)
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.
Alere i Strep A, K141757
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
§ 866.2680
Streptococcus spp. nucleic acid-based assay.(a)
Identification. AStreptococcus spp. nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify variousStreptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.
(3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.
(4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.
(5) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols, as appropriate.
(6) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(8) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 2018
Alere Scarborough, Inc. Danielle Briggeman Regulatory Affairs Specialist 10 Southgate Road Scarborough, Maine 04074
Re: K173653
Trade/Device Name: Alere i Strep A 2. Alere i instrument. Alere i Strep A 2 Control Swab Kit Regulation Number: 21 CFR 866.2680 Regulation Name: Streptococcus spp. nucleic acid-based assay Regulatory Class: Class II Product Code: PGX, OOI Dated: November 21, 2017 Received: November 28, 2017
Dear Danielle Briggeman:
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 Part 801 and Part 809); medical device 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173653
Device Name Alere i Strep A 2
Indications for Use (Describe)
Alere i Strep A 2 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.
| 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) |
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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: K173653
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359
PRIMARY CONTACT PERSON
Danielle Briggeman (207) 730-5750, ext 65925 (Office) (207) 730-5767 (FAX) Danielle.briggeman@alere.com (email)
SECONDARY CONTACT PERSON
Angela Drysdale (207) 415-1393 (Office) (207) 730-5767 (FAX) angela.drysdale@alere.com (email)
DATE PREPARED
May 1, 2018
TRADE NAME
Alere™ i Strep A 2 Alere™ i Instrument Alere™ i Strep A 2 Control Swab Kit
COMMON NAME
Alere™ i Strep 2, Alere™ i
CLASSIFICATION NAME
21 CFR 866.2680 – Streptococcus spp. Nucleic Acid-Based Assay
CLASSIFICATION Class II
PRODUCT CODES PGX, 00I
PANEL Microbiology (83)
PREDICATE DEVICE Alere i Strep A, K141757
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DEVICE DESCRIPTION
Alere™ i Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Streptococus pyogenes Group A Strep from throat swab specimens. The Alere™ i Strep A 2 System utilizes isothermal nucleic acid amplification technology and is 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 Test Base contain the reagents required for Streptococcus pyogenes Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Streptococcus pyggenes, Group A Strep and fluorescently labeled molecular beacons designed to specifically identify the amplified nucleic acid targets. Alere™ i Strep A 2 is 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. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis 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
Alere™ i Strep A 2 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 Streptococus 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 Strep bacterial infections.
TECHNOLOGICAL CHARACTERISTICS
Alere™ i Strep A 2 and the predicate device, Alere™ i Strep A, have the same intended use, indications for use, and utilize similar basic principles of operation. They are both molecular tests for the qualitative detection of Streptococcus pyogenes, Group A Strep nucleic acid.
DEVICE COMPARISON
| Parameter | Alere™ i Strep A 2 | Alere ™ i Strep A (K141757) |
|---|---|---|
| FDA Product Code | PGX, OOI | Same |
| Assay Target | Streptococcus pyogenes (Group A) | Same |
| Intended Use | Alere™ i Strep A 2 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 | 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 |
Alere™ i Strep A 2 was compared to the legally marketed predicate device, the Alere™ i Strep A assay.
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| Parameter | Alere™ i Strep A 2 | Alere ™ i Strep A (K141757) |
|---|---|---|
| Intended Environment for | ||
| Use | patients with signs and symptoms of | |
| pharyngitis. It is intended to aid in the | ||
| rapid diagnosis of Group A | ||
| Streptococcus bacterial infections. | 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. | ||
| 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 | |
| Semi-Automated Assay | Sample preparation, amplification, | |
| detection and result interpretation are | ||
| automated; sample transfer is | ||
| performed manually | Same | |
| Assay Information | ||
| Sample Type | Throat Swab | Same |
| Strep A Target | Streptococcus pyogenes | Same |
| Technology | Isothermal nucleic acid amplification | |
| for detecting the presence/absence of | ||
| bacterial DNA in clinical specimens | Same | |
| Internal Control | Yes | Same |
| Result Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result |