Streptococcus spp. Nucleic Acid-Based Assay is a diagnostic device that uses molecular techniques, like PCR, to detect the genetic material (nucleic acid) of various Streptococcus species directly from a clinical specimen, allowing for rapid and accurate identification of different types of Streptococcus bacteria present in a patient sample, often used for diagnosing infections caused by Streptococcus bacteria like Group A Streptococcus (S. pyogenes) by targeting specific DNA sequences unique to each species.

Intended Use of Streptococcus Spp. Nucleic Acid-Based Assay

A Streptococcus spp. nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify various Streptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus 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. Class II (special controls). It must include in the device labeling the limitations for culture confirmation of negative specimens, a detailed explanation of results interpretation and acceptance criteria, and details on an end user device training program.

Intended Use:

The Test is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of Streptococcus pyogenes (Group A β-haemolytic Streptococcus, Strep A) bacterial nucleic acid. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections from throat swabs of patients with signs and symptoms of pharyngitis. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

Device Description:

The test is a semi-automated, colorimetric PCR nucleic acid amplification system that detects Streptococcus pyogenes from unprocessed throat swabs. It integrates nucleic acid extraction, PCR nucleic acid amplification technology, and hybridization-based visual detection into a self-contained, automated system.

Test Kit contains:

• sterile swabs for throat collection.
• Strep A Buffer.
• Transfer Pipettes.
• Strep A Test Cassettes.
• Strep A Positive Control Swab.
• Negative Control Swab.
• Instructions for use
• Quick Reference Guide.

System Components

• A reusable processing unit that controls sample fluid movement, PCR amplification, and assay timing.
• Disposable test cassettes — single-use units containing reagents for sample lysis, PCR amplification), internal controls, and lateral flow detection.
• Sterile throat swabs and sample buffer — for collection and elution of clinical specimens.
• Visual readout strip — detection zone with capture probes that generate a colored line indicating presence of target nucleic acid; internal control lines enable result validation.

Performance Testing (Analytical-Nonclinical) for Streptococcus Spp. Nucleic Acid-Based Assay  

• Stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances
• Prozone effect study

Clinical Testing:

No Guidance available for 510k submission