STATUS FIRST STREP A

• K Number: K040708
• Device Name: STATUS FIRST STREP A
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 2004-11-22 ( 249 days)
• Product Code: GTY
• Regulation Number: 866.3740
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: k971349
• Predicate For: K133343

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.

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

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Status First™ Strep A device. Instead, the device's performance is established through substantial equivalence to a legally marketed predicate device, BioSign StrepA (K971349).

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent in intended use, principle, and performance to predicate device (BioSign StrepA, K971349).	"The Status First™ Strep A test is substantially equivalent in intended use, principle and performance to the current BioSign Strep A test."
"The two products are identical and use the same manufacturing processes."	Performance is considered identical to the predicate due to identical product and manufacturing processes, with only a minor difference in the sample extraction step described in the package insert.

2. Sample Size for Test Set and Data Provenance:

   • Test Set Sample Size: Not specified. The document focuses on substantial equivalence based on product identity and manufacturing processes, rather than a new clinical performance study with a distinct test set.
   • Data Provenance: Not applicable for a new clinical performance study. The data provenance would be linked to the predicate device's original studies, which are not detailed here. The 510(k) refers to the predicate device BioSign StrepA, K971349.

3. Number of Experts and Qualifications:

   • Not applicable. The submission focuses on substantial equivalence, not a new clinical study requiring expert ground truth establishment for a test set.

4. Adjudication Method:

   • Not applicable. No new clinical performance study is described with a need for adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done or reported in this 510(k) summary. The submission is for an in-vitro diagnostic device, which typically involves analytical performance studies and comparison to a predicate, not human reader performance studies.

6. Standalone Performance:

   • Yes, in a way. The Status First™ Strep A is a standalone in-vitro diagnostic device. Its performance is implicitly the standalone performance as compared to the predicate device. However, a separate, new standalone performance study (i.e., with new data demonstrating accuracy, sensitivity, and specificity) is not detailed as part of this 510(k) submission. Its standalone performance is considered equivalent to the predicate.

7. Type of Ground Truth Used:

   • Not explicitly stated for Status First™ Strep A in this document, as a new performance study wasn't described. For the predicate device, BioSign StrepA, it would typically involve culture methods as the "gold standard" for diagnosing Group A Streptococcal infection to establish true positive/negative results.

8. Sample Size for Training Set:

   • Not applicable. This 510(k) does not describe an AI/machine learning device with a training set. It's an immunoassay.

9. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no training set for this type of immunoassay device.

Summary

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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:________________________________________________________________________________________________________________________________________________

• 1. Date of Summary: Mar. 16, 2004
• Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone [phone] Fax Contact Person: Jemo Kang, Ph.D. ext. 103
• 3. Device Name Trade Names: Status First™ Strep A FDA Classification Name: Immunoassay, Streptococcus SPP. (Microbiology Classification Device List)
• 4. Identification of legally marketed device to which claims equivalence: BioSign StrepA, K971349
• 5. 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
• 6. 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.
• 7. 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.

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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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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 [phone]. 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 [phone] or [phone] 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

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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 DeviceEvaluation and Safety	Page 1 of 1
510(k)	K040708

Regulation Number and Section

§ 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.