(274 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, intended use, or performance studies.
No.
Explanation: This device is an in vitro diagnostic test for detecting Streptococcus pyogenes, which aids in diagnosis. It does not provide treatment or directly interact with the patient in a therapeutic manner.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines multiple hardware components including a Sample Receiver, Test Base, Transfer Cartridge, and the Alere™ i Instrument (a repeat use reader). While software is involved in processing results, it is an integral part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Alere™ i Strep A is a "molecular in vitro diagnostic test".
- Nature of the Test: The device performs a test on a biological sample (throat swab specimens) in vitro (outside of the body) to detect the presence of a specific substance (Streptococcus pyogenes bacterial nucleic acid) to aid in diagnosis. This is the core definition of an in vitro diagnostic device.
- Device Description: The description details the components and process of performing the test on the collected sample, further confirming its function as an IVD.
N/A
Intended Use / Indications for Use
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 preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
Product codes
PGX, OOI
Device Description
Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. The Alere™ i Strep A 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 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. Alere™ i Strep A 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 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 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
all ages
Intended User / Care Setting
Not Found
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
CLINICAL STUDY
The clinical performance of Alere™ i Strep A was established in a multi-center, prospective clinical study conducted at 8 US trial sites in 2014.
A total of 481 evaluable throat swab specimens, collected from patients of all ages presenting with symptoms of pharyngitis, were evaluated with Alere™ i Strep A, and compared to bacterial culture. Sixty-two percent (62%) of the population tested was female and 38% was male.
In this study, two (2) throat swabs were collected from each of 481 patients. One throat swab from each patient was tested with Alere™ i Strep A. The other throat swab was sent to a laboratory for bacterial culture.
Key Metrics
Sensitivity: 141/147 = 95.9% (95% CI = 91.4% 98.1%)
Specificity: 316/334 = 94.6% (95% CI = 91.6%, 96.6%)
Positive Predictive Value = 141/159 = 88.7% (82.8%, 92.7%
Negative Predictive Value = 316/322 = 98.1% (96.0%, 99.1%)
a Of the 18 samples positive by Alere™ i Strep A and negative by bacterial culture, 13 were also positive for Group A Strep by a laboratory developed real-time PCR assay and © of the 6 samples negative by Alere™ i Strep A and positive by bacterial culture, 4 samples were also negative for Group A Strep by a laboratory developed real-time PCR assay.
During the prospective clinical study, the initial invalid rate (before repeat testing per the product instructions) was 4.8% (24/495) (95% Cl: 3.3%, 7.1%). After repeat testing per the product instructions, the invalid rate was 2.8% (14/495) (95% CI: 1.7%, 4.8%).
Predicate Device(s)
Lyra Direct Strep Assay, K133883
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ALERE SCARBOROUGH, INC ANGELA DRYSDALE VP, REGULATORY & CLINICAL AFFAIRS 10 SOUTHGATE ROAD SCARBOROUGH ME 04074
March 31, 2015
Re: K141757
Trade/Device Name: Alere i Strep A Regulation Number: 21 CFR 866.2680 Regulation Name: Streptococcus spp. Nucleic Acid-Based Assay Regulatory Class: II Product Code: PGX, OOI Dated: March 9, 2015 Received: March 10, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Uwe Scherf -S for
Sally 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
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Indications for Use
510(k) Number (if known) K141757
Device Name Alere™ i Strep A
Indications for Use (Describe)
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) |
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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: K141757
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
3/26/2015
TRADE NAME
Alere™ i Strep A
COMMON NAME
Alere™ i Strep, Alere™ i, Alere™ Strep A
CLASSIFICATION NAME
Groups A, C and G Beta Hemolytic Streptococcus Nucleic acid Amplification System (per 21 CFR 866.2680) Real Time Nucleic Acid Amplification System (per 21 CFR 862.2570)
CLASSIFICATION Class II
PRODUCT CODE PGX, 00I
PANEL Microbiology (83)
PREDICATE DEVICE Lyra Direct Strep Assay, K133883
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DEVICE DESCRIPTION
Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. The Alere™ i Strep A 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 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. Alere™ i Strep A 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 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 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 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 pharvngitis. 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 Streptoccus and should not be used as the sole basis for treatment.
TECHNOLOGICAL CHARACTERISTICS
Alere™ i Strep A and the predicate device, Lyra Direct Strep Assay, 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 Group A Strep nucleic acid.
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DEVICE COMPARISON
| Parameter | Alere™ i Strep A | Lyra Direct Strep Assay (K133883) |
|---|---|---|
| FDA Product Code | PGX, OOI | Same |
| Assay Target | Streptococcus pyogenes | Streptococcus pyogenes , pyogenic Group C and G |
| ß-hemolytic Streptococcus | ||
| Intended Use | 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 preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment, | The Lyra Direct Strep Assay is a Real-Time PCR in vitro diagnostic test for the qualitative detection and differentiation of Group A ß-hemolytic Streptococcus ( Streptococcus pyogenes ) and pyogenic Group C and G ß-hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The assay does not differentiate between pyogenic Groups C and G ß-hemolytic Streptococcus . | |
| All negative test results should be confirmed by bacterial culture, because negative results do not preclude Group A, C or G Strep infection and should not be used as the sole basis for treatment. | ||
| The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use. | ||
| Instrumentation | Alere™ i Instrument | ABI 7500 Fast DX Thermocycler |
| Assay Information | ||
| Sample Type | Throat Swab | Same |
| Target Analyte | Group A Streptococcus | |
| ( Streptococcus pyogenes ) | Group A Streptococcus ( Streptococcus pyogenes ) | |
| Groups C and G Streptococcus | ||
| Technology | Isothermal nucleic acid amplification | Multiplex Real-time PCR |
| Internal Control | Yes | Same |
| Result | Automated | Same |
| Interpretation | ||
| Assay Result | Qualitative | Same |
| Time to Result | 106 cells/mL of Elution Buffer 2One false-positive result obtained a >108 cells/mL of Elution Buffer |
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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 at the concentrations listed below and were found not to affect test nerformance.
| Substance | Concentration |
|---|---|
| Whole Blood | 5% (v/v) |
| Mucin | 0.016% (w/v) |
| Human Saliva | 10% (v/v) |
| Ibuprophen | 15.4 mg/mL |
| Acetaminophen | 19.4 mg/mL |
| Acetylsalicylic acid | 12.4 mg/mL |
| Albuterol | 0.5 mg/mL |
| Diphenhydramine HCL | 2.7 mg/mL |
| Cepacol® Sore Throat Lozenges - cherry | 20% (w/v) |
| Sucrets® Sore Throat & Cough - cherry | 20% (w/v) |
| Halls Plus® - Honey Lemon | 20% (w/v) |
| ACT® Total Care - Fresh Mint | 20% (v/v) |
| Cepacol® Mouthwash | 20% (v/v) |
| Listerine® Antiseptic Mouthwash - Original | 20% (v/v) |
| Crest® Complete Multi-Benefit Whitening + | |
| Deep Clean Toothpaste | 0.16% (w/v) |
| Zicam® Oral Mist - arctic mint | 20% (v/v) |
| Chloraseptic® Max Sore Throat Relief + | |
| Coating Action - wild berry | 20% (v/v) |
| Contact Cold & Flu Tablets - Night | 20% (w/v) |
| Robitussin® Maximum Strength Nighttime | |
| Cough DM | 20% (v/v) |
| Tylenol® Cold Multi-Symptom Liquid | 20% (v/v) |
| Children's Dimetapp® Cough & Cold | 20% (v/v) |
When Mucin was tested at a concentration of 2%, 0.4%, and 0.08%, false negative results were observed.
When Crest® Complete Multi-Benefit Whitening + Deep Clean Toothpaste were tested at 20% and 4% invalid results were observed. Additionally, false negative results were observed when tested at a concentration of 0.8%.
REPRODUCIBILITY
A reproducibility study of Alere™ i Strep A was conducted by operators from 3 sites using panels of blind coded specimens containing negative (below the limit of detection), low positive (~3X limit of detection), and moderate positive (~19X 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 Strep A moderate positive and low positive samples were 100% (90/90) and 91.1% (82/90). All of the negative samples (90) generated negative test results as did 94.4% (85/90) high negative samples. There were a total of 5 invalid results on initial testing (5/360 samples; 1.4%). There were no significant differences within run (replicates tested by one operator'), between run (5 different days), between sites (3 sites), or between operators (6 operators).
The results of the analytical and clinical studies performed with Alere™ i Strep A support the determination of substantial equivalence in accordance with the stated intended use and device labeling.