Healgen Strep A Rapid Test Strip (Throat Swab)

• K Number: K212623
• Device Name: Healgen Strep A Rapid Test Strip (Throat Swab)
• Manufacturer: Healgen Scientific, LLC
• Date Cleared: 2022-03-16 ( 210 days)
• Product Code: GTY
• Regulation Number: 866.3740
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: K133343

Intended Use

The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassy for the qualitative detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus, Strep A) antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection.

All negative test results should be confirmed by bacterial culture because negative results do not prection with Group A Streptococcus and should not be used as the sole basis for treatment.

Device Description

Healgen Strep A Rapid Test Strip (Throat Swab) is a qualitative, lateral flow immunoassay for the detection of Strep A antigen directly from a throat swab sample.

In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Healgen Strep A Rapid Test Strip (Throat Swab):

1. Table of Acceptance Criteria and Reported Device Performance

Device Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Analytical Performance
Precision/Reproducibility	Results should be reproducible across different users, sites, lots, and days.	Overall Positive Detection:

• True negative sample: 0% (0/180)
• Moderate positive sample (1.8x10^4 CFU/mL): 100% (180/180)
• LoD sample (7.2x10^3 CFU/mL): 95.6% (172/180)
• Low negative sample (3.6x10^3 CFU/mL): 44.4% (80/180)
  (Concluded: No significant differences between users, sites, lots, and days; results are reproducible with good precision.) |
  | Limit of Detection (LoD) | The LoD should be clearly established for both clinical matrix and saline solution. | LoD in clinical matrix: 7.2x10^3 CFU/mL (equivalent to 360 bacteria on the swab) based on 95.2% detection (20/21) at 7.2x10^4 CFU/mL.
  LoD in saline solution: 7.2x10^3 CFU/mL (equivalent to 360 bacteria on the swab) based on 95.2% detection (20/21) at 7.2x10^3 CFU/mL. |
  | Interference | No false positive or false negative results with common interfering substances (blood, mucus, saliva, medications). | No false positive or false negative results observed with various interfering substances (blood, mucin, OTC mouthwashes, lozenges, throat sprays, cough syrups, active ingredients such as acetaminophen, ibuprofen, etc.) at tested concentrations (e.g., 20% vol/vol for liquids, 5mg/mL for solids). |
  | Analytical Specificity | No cross-reactivity with other common respiratory tract organisms (bacteria and viruses). | No cross-reactivity found for a comprehensive list of organisms (e.g., Arcanobacterium haemolyticum, Bordetella pertussis, Candida albicans, Enterococcus faecalis, Escherichia coli, various Streptococcus species, Adenovirus, Cytomegalovirus, HSV, etc.) at tested concentrations. |
  | Clinical Performance | | |
  | Clinical Sensitivity | Performance comparable to the legally marketed predicate device (Predicate: 95% CI (88-98%)). | Overall Clinical Sensitivity: 97.1% (200/206) with 95% CI (93.7-98.8%)
• Age 0-5: 97.4% (74/76)
• Age 5-21: 96.7% (119/123)
• Age 21+: 100% (7/7)
  (No statistical differences between age groups.) |
  | Clinical Specificity | Performance comparable to the legally marketed predicate device (Predicate: 98% CI (96-99%)). | Overall Clinical Specificity: 99.4% (161/162) with 95% CI (96.2-100.0%)
• Age 0-5: 98.1% (52/53)
• Age 5-21: 100% (88/88)
• Age 21+: 100% (21/21)
  (No statistical differences between age groups.) |
  | Consistency | Performance across different age groups should be consistent. | No statistical differences in performance between age groups. |

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • Clinical Study: 368 subjects (206 culture-positive, 162 culture-negative).
  • Analytical Precision: 180 determinations per sample type (60 determinations per site across 3 sites).
  • Analytical LoD: 21 results per dilution (7 operators x 3 lots).
  • Analytical Interference: Multiple tests across 3 lots for each interfering substance, for both positive and negative specimens.
  • Analytical Specificity (Cross-reactivity): Multiple tests across 3 lots for each organism by 3 professional users.
• Data Provenance:
  • The document does not explicitly state the country of origin for the clinical data.
  • The clinical study appears to be prospective/concurrent as it describes testing "subjects...exhibiting symptoms of pharyngitis by both the Healgen Strep A Rapid Test Strip (Throat Swab) and the culture studies." This implies collection of samples and testing using both methods at the time of study.
  • The analytical studies (precision, LoD, interference, specificity) were laboratory-based, performed internally or by designated personnel.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Clinical Study Ground Truth: The ground truth for the clinical study was established by bacterial culture. The document implies that the culture results were considered the reference standard. It does not explicitly state the number of experts or their qualifications involved in performing or interpreting these cultures. However, bacterial culture is a standard clinical laboratory method typically performed by trained medical technologists or microbiologists.
• Analytical Studies:
  • Precision/Reproducibility: 6 professional operators (2 at each of 3 sites) participated. Their specific qualifications are not detailed beyond "professional operators."
  • LoD: 7 operators performed the testing. Their specific qualifications are not detailed beyond "operators."
  • Interference: 3 laboratory assistants with relevant experience performed the test.
  • Analytical Specificity: 3 professional users performed the test.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• The document does not describe an adjudication method (like 2+1 or 3+1) for establishing the ground truth in the clinical study. The reference standard (bacterial culture) appears to have been used directly.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done in the context of AI assistance. This device is a manual rapid diagnostic test strip, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here. The "operators" or "users" in the analytical studies are performing the manual test according to instructions.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the device is a manual rapid test strip, not an algorithm or AI-driven system. It does not operate without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the clinical study was bacterial culture, which is considered the gold standard for diagnosing Group A Streptococcus bacterial infection.
• For the analytical studies (LoD, interference, specificity), the ground truth was based on known concentrations of target analytes (S. pyogenes) or known presence/absence of interfering/cross-reacting organisms.

8. The sample size for the training set

• The document does not mention a training set in the context of machine learning or AI. This is a traditional rapid diagnostic test, not a learning algorithm. The "training" of the device refers to its manufacturing and validation process, not data-driven machine learning.

9. How the ground truth for the training set was established

• This question is not applicable as there is no mention or indication of a "training set" for an AI or machine learning model in this submission.

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.