(107 days)
Not Found
No
The device description details a lateral flow immunoassay based on chemical reactions and visual interpretation of lines, with no mention of computational analysis, algorithms, or learning processes.
No
This device is a diagnostic test for detecting Strep A antigen, not a therapeutic device designed to treat or alleviate a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of Group A Streptococcal infection."
No
The device description clearly outlines a physical, lateral flow immunoassay kit involving reagents, tubes, swabs, and a test strip, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection." This clearly indicates it's used to test a sample taken from the human body to provide information for diagnosis.
- Device Description: The description details a "rapid chromatographic immunoassay" that detects an "antigen directly from a throat swab sample." This describes a test performed in vitro (outside the body) on a biological specimen.
- Mechanism: The mechanism involves chemical reactions between the sample and reagents on a test strip to produce a visible result, which is characteristic of many IVD tests.
- Clinical Performance Study: The document describes a clinical study where the device was compared to bacterial culture using throat swab specimens, which is a standard way to evaluate the performance of an IVD for infectious disease detection.
- Predicate Device: The mention of a predicate device (K992658; Genzyme OSOM® Ultra Strep A Test) which is also an IVD, further supports that this device falls into the same category.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Clearview Advanced™ Strep A test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection.
Product codes (comma separated list FDA assigned to the subject device)
GTY
Device Description
The Clearview Advanced™ Strep A test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen directly from a throat swab sample. To perform the test, Reagent 1 (R1) is added to the extraction tube which is coated with a mixture of conjugate antibodies and a lytic enzyme extraction reagent. The lytic enzyme is mixed with colloidal gold conjugated to rabbit anti-Strep A and a second colloidal gold control coniugate antibody. The reagents are dried onto the bottom of an extraction tube forming a red spot. The extraction/conjugate pellet is resuspended with R1 and the throat swab is added to the extraction tube. The Strep A antigen is extracted from the sample and the swab is removed. The test strip is immediately placed in the extracted sample. If Group A Streptococcus is present in the sample, it will react with the anti-Strep A antibody conjugated to the gold particle. The complex will then be bound by the anti-Strep A capture antibody and a visible red test line will appear, indicating a positive result. To serve as an onboard procedural control, the blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly. If Strep A antigen is not present, or present at very low levels, only a red control line will appear. If the red control line does not appear, or remains blue, the test result is invalid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
multi-center, prospective clinical study conducted in 2008-2009 at five geographically diverse physician office, clinics, and emergency departments within the United States.
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)
Clinical Performance:
The clinical performance of the Clearview Advanced Strep A test was established in a multi-center, prospective clinical study conducted in 2008-2009 at five geographically diverse physician office, clinics, and emergency departments within the United States.
A total of 297 throat swab specimens were evaluated by comparing the Clearview Advanced Strep A test to bacterial culture.
Key results: Sensitivity was 91.5% (95% Cl 85.0% to 95.3%) and specificity was 95.0% (95% Cl 90.7% to 97.3%).
Analytical Sensitivity (Limit of Detection):
The limit of detection (LOD) was determined by evaluating different concentrations of Group A Streptococcus.
The detection limit of the Clearview Advanced Strep A test was determined to be 1x10^4 organisms/test.
Analytical Specificity (Cross-Reactivity):
38 commensal and pathogenic microorganisms including bacteria, viruses and yeast that may be present in the mouth or throat were tested to determine analytical specificity.
All of the tested microorganisms were negative when tested at a concentration of 1x10^6 organisms/test.
Reproducibility:
A blind study was conducted at 3 separate sites using panels of blind coded specimens.
Participants tested each sample multiple times on 5 different days.
No significant difference between runs (5 different days), between sites (3 sites), and between operators (6 operators).
| Sample | Site 1 Detection | Site 2 Detection | Site 3 Detection | Overall Detection |
|---|---|---|---|---|
| Diluent (True Negative) | 0% (0/60) | 0% (0/60) | 0% (0/59)** | 0% (0/179) |
| 1x10^5 (Moderate Positive) | 100% (60/60) | 98% (59/60) | 100% (60/60) | 99% (179/180) |
| 1x10^4 (LOD/C95 Concentration) | 100% (60/60) | 100% (60/60) | 83% (50/60) | 94% (170/180) |
| 3.2x10^3 (Near the cut-off/C50Concentration) | 80% (48/60) | 58% (34/59)* | 10% (6/60) | 49% (88/179) |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity-91.5% (85.0% to 95.3%)
Specificity-95.0% (90.7% to 97.3%)
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.
Genzyme OSOM® Ultra Strep A Test (K992658)
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
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. 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 I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
13
SEP 0 4 2009
SUBMITTER
Binax, Inc. 10 Southgate Rd Scarborough, ME 04074 (207) 730-5824 (Office) (207) 730-5717(Fax)
CONTACT PERSON
Erin E. Kenaley Erin.Kenaley@invmed.com (email)
DATE PREPARED
August 13, 2009
TRADE NAME
Clearview Advanced ™ Strep A Test
COMMON NAME
Rapid Strep A test, Strep A dipstick test
CLASSIFICATION NAME
Antigens, All Groups, Streptococcus Spp. Serological Reagents (GTY) (per 21 CFR 866.3740)
PREDICATE DEVICES
Genzyme OSOM® Ultra Strep A Test (K992658)
DEVICE DESCRIPTION:
The Clearview Advanced™ Strep A test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen directly from a throat swab sample. To perform the test, Reagent 1 (R1) is added to the extraction tube which is coated with a mixture of conjugate antibodies and a lytic enzyme extraction reagent.
The lytic enzyme is mixed with colloidal gold conjugated to rabbit anti-Strep A and a second colloidal gold control coniugate antibody. The reagents are dried onto the bottom of an extraction tube forming a red spot. The extraction/conjugate pellet is resuspended with R1 and the throat swab is added to the extraction tube. The Strep A antigen is extracted from the sample and the swab is removed. The test strip is immediately placed in the extracted sample. If Group A Streptococcus is present in the sample, it will react with the anti-Strep A antibody conjugated to the gold particle. The complex will then be bound by the anti-Strep A capture antibody and a visible red test line will appear, indicating a positive result. To serve as an onboard procedural control, the blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly. If Strep A antigen is not present, or present at very low levels, only a red control line will appear. If the red control line does not appear, or remains blue, the test result is invalid.
1
INTENDED USE
The Clearview Advanced Strep A test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection.
TECHNOLOGICAL CHARACTERISTICS
The Clearview Advanced Strep A test and the Genzyme OSOM Ultra Test utilize similar lateral flow immunochromatographic technology. Both tests are rapid immunoassays that employ specific antibodies immobilized onto a solid phase to capture and visualize Group A Streptococcal antigens.
PERFORMANCE SUMMARY
Clinical Performance
The clinical performance of the Clearview Advanced Strep A test was established in a multi-center, prospective clinical study conducted in 2008-2009 at five geographically diverse physician office, clinics, and emergency departments within the United States.
A total of 297 throat swab specimens were evaluated by comparing the Clearview Advanced Strep A test to bacterial culture. In this study, sensitivity was 91.5% (95% Cl 85.0% to 95.3%) and specificity was 95.0% (95% Cl 90.7% to 97.3%).
| Bacterial Culture Results | |||
|---|---|---|---|
| Positive | Negative | ||
| Clearview Advanced Strep A | Positive | 107 | 9 |
| Test Results | Negative | 10 | 170 |
| Total | 117 | 179 |
denotes 95% Confidence Interval Sensitivity-91.5% (85.0% to 95.3%)* Specificity-95.0% (90.7% to 97.3%)*
Analytical Sensitivity (Limit of Detection)
The Clearview Advanced Strep A test limit of detection (LOD), defined as the concentration of Group A Streptococcus bacteria that produces positive Clearview Advanced Strep A test results approximately 95% of the time, was identified by evaluating different concentrations of Group A Streptococcus in the Clearview Advanced. Strep A test. The detection limit of the Clearview Advanced Strep A test was determined to be 1x104 organisms/test.
Analytical Specificity (Cross-Reactivity)
To determine the analytical specificity of the Clearview Advanced Strep A test, 38 commensal and pathogenic microorganisms including bacteria, viruses and yeast that may be present in the mouth or throat were tested. All of the following microorganisms were negative when tested at a concentration of 1x10° organisms/test.
Streptococcus salivarius Haemophilus parainfluenzae. Streptococcus Group B Neisseria subflava Proteus vulgaris Arcanobacterium haemolyticum Haemophilus influenzae Streptococcus Group C Pseudomonas aeruginos Streptococcus Group F Bordetella pertussis Klebsiella pneumoniae
2
Streptococcus Group G. Streptococcus anginosus Streptococcus mitis Streptococcus mutans Streptococcus oralis Streptococcus pneumoniae Streptococcus sanguis
Candida albicans Corynebacterium diphtheriae Enterococcus faecalis Enterococcus faecium. Escherichia coli Fusobacterium necrophorum. Haemophilus parahaemolyticus
Moraxella catarrhalis Moraxella lacunata Neisseria gonormoeae Neisseria lactamica Neisseria meningitides Neisseria mucosa Neisseria sicca
Serratia marcescens. Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Yersinia enterocolitica
Reproducibility
A blind study of the Clearview Advanced Strep A test was conducted at 3 separate sites using panels of blind coded specimens. Participants tested each sample multiple times on 5 different days, with no significant difference between runs (5 different days), between sites (3 sites), and between operators (6 operators). The results are presented below:
| Sample | Site 1
Detection | Site 2
Detection | Site 3
Detection | Overall
Detection |
|-------------------------------------------------|---------------------|---------------------|---------------------|----------------------|
| Diluent (True Negative) | 0% (0/60) | 0% (0/60) | 0% (0/59)** | 0% (0/179) |
| 1x105 (Moderate Positive) | 100% (60/60) | 98% (59/60) | 100% (60/60) | 99% (179/180) |
| 1x104 (LOD/C95 Concentration) | 100% (60/60) | 100% (60/60) | 83% (50/60) | 94% (170/180) |
| 3.2x103 (Near the cut-off/C50
Concentration) | 80% (48/60) | 58% (34/59)* | 10% (6/60) | 49% (88/179) |
2 invalid results excluded from the data analysis
Signed Angela Lupdale Date 8/14/09
Angela Drysdale Sr. Manager of Clinical Affairs
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Erin E. Kenalev Clinical Affairs Specialist Binax, Inc. 10 Southgate Road Scarborough, ME 04074
Re: K091489
Trade/Device Name: Clearview Advanced TM Strep A Test Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. exo-enzyme reagents Regulatory Class: Class I Product Code: GTY Dated: August 13, 2009 Received: August 19, 2009
Dear Ms. Kenaley:
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.
SEP 0 4 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
4
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Say cazino
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K091489
Device Name: Clearview Advanced™ Strep A Test
Indication For Use:
The Clearview Advanced™ Strep A test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection.
Prescription Use ਮ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Freddie Leach
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K691489
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