(249 days)
Not Found
No
The summary describes a simple immunoassay (lateral flow test) for detecting Strep A antigen. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies. The description aligns with a traditional in vitro diagnostic test.
No
This device is a qualitative diagnostic test designed to detect the presence of Group A Strep antigen, aiding in diagnosis. It does not provide therapy or treatment.
Yes
The text explicitly states that the device is a "diagnostic test" and its intended use is "to aid in the early diagnosis of Group A Streptococcal infection."
No
The device description clearly states it is an "in vitro, simple, one step immunochromatographic diagnostic test," which is a hardware-based immunoassay, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's an "immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection." This clearly indicates it's used to test a sample taken from the human body (throat swab) in vitro (outside the body) to diagnose a condition.
- Device Description: The description further reinforces this by stating it's an "in vitro, simple, one step immunochromatographic diagnostic test for the rapid, qualitative detection of Group A Streptococcal antigen." The term "in vitro" is a direct indicator of an IVD.
N/A
Intended Use / Indications for Use
Status First™ Strep A is an immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
Product codes (comma separated list FDA assigned to the subject device)
GTY
Device Description
Status First"" Strep A is an in vitro, simple, one step immunochromatographic diagnostic test for the rapid, qualitative detection of Group A Streptococcal antigen
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 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
NOV 2 2 2004
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
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- Date of Summary: Mar. 16, 2004
- Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone 732-274-1000 732-274-1010 Fax Contact Person: Jemo Kang, Ph.D. ext. 103
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- Device Name Trade Names: Status First™ Strep A FDA Classification Name: Immunoassay, Streptococcus SPP. (Microbiology Classification Device List)
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- Identification of legally marketed device to which claims equivalence: BioSign StrepA, K971349
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- Device Description: Status First"" Strep A is an in vitro, simple, one step immunochromatographic diagnostic test for the rapid, qualitative detection of Group A Streptococcal antigen
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- Intended Use: Status First" Strep A is an immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
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- Substantial Equivalence: The Status First" Strep A test is substantially equivalent in intended use, principle and performance to the current BioSign Strep A test. Both assays are in vitro immunochromatographic assays with an intended use as an aid in the early diagnosis of Group A Streptococcal infection.
There is no formulation change associated with the BioSign Strep A labeling change. The two products are identical and use the same manufacturing processes. Only the sample extraction step is different in the package insert.
Conclusion: The device is substantially equivalent to a legally marketed device, K971349.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 2 2004
Jemo Kang, Ph.D. President Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction., NJ 08852-1905
K040708 Re: Trade/Device Name: Status First™ Strep A Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus Spp. Serological Reagents Regulatory Class: Class I Product Code: GTY Dated: October 1, 2004 Received: October 4, 2004
Dear Dr. Kang:
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.
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 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).
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Page 2
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). You may obtain other general information on your responsibilities under the Act 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,
Saqartys
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
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Status First™ Strep A Indications For Use:
Status First™ Strep A is an immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
Prescription Use: (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Device Evaluation (OIVD) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | Page 1 of 1 |
| 510(k) | K040708 |