BIOSTREP A-DIRECT STREP A ANTIGEN TEST

• K Number: K983386
• Device Name: BIOSTREP A-DIRECT STREP A ANTIGEN TEST
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 1998-11-25 ( 60 days)
• Product Code: GTY
• Regulation Number: 866.3740
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The BioStrep® A is intended for use as an in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called BioStrep® A. While it confirms the device's substantial equivalence and outlines regulatory guidelines, it does not contain any information regarding specific acceptance criteria, study details, or performance metrics for the device. Therefore, I cannot generate the requested information based on the given input.

The document states:

• The device is a "BioStrep® A" intended for the "qualitative detection of group A streptococcal antigen directly from throat swab specimens."
• It's for "in vitro diagnostic product" use in "physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection."
• It refers to a "legally marketed predicate device" for substantial equivalence but does not provide details about that predicate's performance or the specific study comparing the BioStrep® A to it.

To answer your request, I would need a document that describes the clinical performance study, including acceptance criteria (e.g., sensitivity, specificity thresholds), the results of that study, and details about the data collection and analysis.

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.