(159 days)
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No
The device description details a simple immunoassay that relies on visual interpretation of color changes to indicate the presence or absence of the antigen. There is no mention of any computational analysis, algorithms, or learning processes that would suggest the use of AI or ML.
No
This device is an immunoassay for the qualitative detection of group A streptococcal antigen. Its purpose is to aid in diagnosis, not to provide therapy or treatment.
Yes
This device is designed to detect group A streptococcal antigen from throat swab specimens to aid in the diagnosis of diseases caused by group A Streptococcus, which is a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay kit involving reagents, a reaction unit, and visual interpretation of lines, indicating it is a hardware-based diagnostic test, not software-only.
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 group A streptococcal antigen from throat swab specimens" and is used "to aid in the diagnosis of diseases caused by group A Streptococcus." This clearly indicates it's used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a test that analyzes a biological sample (throat swab specimen) using chemical reagents and a reaction unit to detect a specific analyte (group A streptococcal antigen). This is the core function of an in vitro diagnostic device.
- Anatomical Site: The specimen is taken from a human anatomical site (throat).
- Intended User: The test is intended for "health care professionals," "laboratory and professional use," and "Physicians' Office," which are typical settings for IVD use.
The description aligns perfectly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The CARDS Q.S. Strep A/Concise Performance Plus Strep A is a sensitive immunoassay for the qualitative detection of group A streptococcal antigen from throat swab specimens. This test is to be used to aid in the diagnosis of diseases caused by group A Streptococcus. The test is for use by health care professionals.
Product codes
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Device Description
The device, CARDS Q.S. Strep A (also sold under the brand name Concise Performance Plus Strep A), is similar to other FDA-cleared devices used for the qualitative detection of group A streptococcal antigen from throat swab specimens, thereby aiding in the diagnosis of diseases caused by group A Streptococcus.
To perform the test, a throat swab specimen is collected. Antigen is extracted from the swab specimen with Reagents A and B. The extracted sample is added to the Reaction Unit. If the sample contains strep A antigen, a pink vertical line forms in the Read Result Window. This pink vertical line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If strep A antigen is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate a negative result.
As the sample continues to move through the test, the procedural Control Window containing strep A antigen becomes pink. Pink color in the Control Window confirms that the test is functionally active and has been performed correctly. The appearance of blue color in the Test Complete Window indicates the completion of the test. This occurs within approximately 5 minutes of adding the extracted sample to the Reaction Unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
throat swab specimens
Indicated Patient Age Range
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Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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- The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
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- The test was shown to have excellent intra- and inter-assay precision.
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- Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
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- Common bacterial microorganisms and potentially interferring substances were shown not to interfere with the test's performance.
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- A multi-center evaluation of the CARDS Q.S. Strep A/Concise Performance Plus Strep A test was conducted to determine the clinical performance of the test relative to standard culture techniques to establish substantial equivalence.
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- Physicians’ Office studies were conducted to show that office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. These studies were performed at three geographically distinct sites in the United States.
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- Stability studies are underway to establish the shelf-life of the product as well as its optimal storage and shipping conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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XI. SUMMARY OF SAFETY AND EFFECTIVENESS
APR 1 5 1996
Product:
CARDS® Q.S.® Strep A; or Concise® Performance Plus™ Strep A
Distributor:
Pacific Biotech, Incorporated a subsidiary of QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121
Device Classification:
The device, CARDS Q.S. Strep A (also sold under the brand name Concise Performance Plus Strep A), is similar to other FDA-cleared devices used for the qualitative detection of group A streptococcal antigen from throat swab specimens, thereby aiding in the diagnosis of diseases caused by group A Streptococcus. The FDA has proposed that serological tests systems for the identification of group A Streptococcus from clinical specimens be classified as Class I.
Intended Use:
The CARDS Q.S. Strep A/Concise Performance Plus Strep A is a sensitive immunoassay for the qualitative detection of group A streptococcal antigen from throat swab specimens. This test is to be used to aid in the diagnosis of diseases caused by group A Streptococcus. The test is for use by health care professionals.
Physiologic Basis for the Test:
Group A Streptococci are organisms that typically cause illness such as tonsillitis, pharyngitis and scarlet fever. If untreated, these infections can lead to complications such as rheumatic fever and glomerulonephritis.
Principle of the Test:
To perform the test, a throat swab specimen is collected. Antigen is extracted from the swab specimen with Reagents A and B. The extracted sample is added to the Reaction Unit.
1
If the sample contains strep A antigen, a pink vertical line forms in the Read Result Window. This pink vertical line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If strep A antigen is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate a negative result.
As the sample continues to move through the test, the procedural Control Window containing strep A antigen becomes pink. Pink color in the Control Window confirms that the test is functionally active and has been performed correctly. The appearance of blue color in the Test Complete Window indicates the completion of the test. This occurs within approximately 5 minutes of adding the extracted sample to the Reaction Unit.
Safety and Effectiveness:
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for qualitative detection of group A streptococcal antigen. These studies included the following:
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- The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
-
- The test was shown to have excellent intra- and inter-assay precision.
-
- Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
-
- Common bacterial microorganisms and potentially interferring substances were shown not to interfere with the test's performance.
-
- A multi-center evaluation of the CARDS Q.S. Strep A/Concise Performance Plus Strep A test was conducted to determine the clinical performance of the test relative to standard culture techniques to establish substantial equivalence.
2
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- Physicians' Office studies were conducted to show that office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. These studies were performed at three geographically distinct sites in the United States.
-
- Stability studies are underway to establish the shelf-life of the product as well as its optimal storage and shipping conditions.
Conclusion:
These studies demonstrated the substantial equivalence of the CARDS Q.S. Strep A/Concise Performance Plus Strep A to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.