(210 days)
Not Found
No
The device description details a lateral flow immunoassay based on antibody-antigen reactions and visual interpretation of color lines. There is no mention of AI/ML terms, image processing, or data training/testing sets related to algorithmic performance.
No.
This device is designed to detect the presence of Strep A antigen to aid in diagnosis, not to treat or directly manage a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of Group A Streptococcus bacterial infection." This clearly indicates its role in the diagnostic process.
No
The device description clearly outlines a physical, lateral flow immunoassay test strip that uses antibodies and chemical reactions to detect Strep A antigen. This involves hardware components (the strip itself, reagents) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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." This involves testing a sample taken from the body (in vitro) to provide information for diagnosis.
- Device Description: The description details a "rapid chromatographic immunoassy" that detects an antigen from a "throat swab specimen." This is a classic description of an in vitro diagnostic test.
- Specimen Type: It uses a "throat swab specimen," which is a biological sample taken from the body.
- Purpose: The purpose is to "aid in the diagnosis" of a bacterial infection.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes (Group A B-hemolytic 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 preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
Product codes (comma separated list FDA assigned to the subject device)
GTY
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.
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
Prescription Use
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)
Analytical Performance
- Precision/Reproducibility: A test panel consisting of a true negative sample (diluent only), a low negative sample (3.6x10^2 CFU/mL), a moderate positive sample (1.8x10^4 CFU/mL) and a LoD sample (7.2x10^3 CFU/mL) were tested. Three lots of the device were used. The study was performed in two runs per day for 5 different days at three different sites. Six professional operators (two operators at each site) participated. Each operator tested two runs per day at each concentration with three lots of Healgen Strep A Rapid Test Strip (Throat Swab), making a total of 30 determinations by each operator at each concentration.
- Results:
- True negative sample (Diluent only): 0% (0/180) overall positive detection.
- Moderate positive sample, 1.8x10^4 CFU/mL: 100% (180/180) overall positive detection.
- LoD sample, 7.2x10^3 CFU/mL: 95.6% (172/180) overall positive detection.
- Low negative sample, 3.6x10^3 CFU/mL: 44.4% (80/180) overall positive detection.
- Conclusion: No significant differences in test results between different users, sites, and lots on different days. Results are reproducible with good precision.
- Results:
- Linearity: Not applicable.
- Stability: Stable at 4-30°C for 24 months based on real-time stability determination at both 4°C and 30°C.
- LoD (Limit of Detection):
- Clinical Matrix: The LoD was established using limiting dilutions of Streptococcus pyogenes and tested by spiking with clinical matrix. A concentrated stock (3.6 x 10^7 CFU/mL) of inactivated S. pyogenes ATCC 19615 was serially diluted in saline solution. 5 uL of each contrived dilution sample was pipetted onto negative throat swab clinical matrix for testing. Each dilution was tested by seven operators with three lots of Healgen Strep A Rapid Test Strip (Throat Swab), for a total of 21 results for each dilution.
- Results: LoD determined to be 7.2x10^3 CFU/mL when 5 uL of sample was pipetted onto a negative clinical matrix (equivalent to 360 bacteria on the swab), with 95.2% detection (20/21).
- Saline Solution: The LoD was also examined by using limiting dilutions of S. pyogenes ATCC 19615 in saline and pipetting 50 uL of each dilution with equivalent bacterial amounts as those used with the clinical matrix onto a swab.
- Results: LoD determined to be 7.2x10^3 CFU/mL when 50 µL of sample was pipetted onto a swab (equivalent to 360 bacteria on the swab), with 95.2% detection (20/21). This is consistent with the LoD established using negative throat swab clinical matrix.
- Clinical Matrix: The LoD was established using limiting dilutions of Streptococcus pyogenes and tested by spiking with clinical matrix. A concentrated stock (3.6 x 10^7 CFU/mL) of inactivated S. pyogenes ATCC 19615 was serially diluted in saline solution. 5 uL of each contrived dilution sample was pipetted onto negative throat swab clinical matrix for testing. Each dilution was tested by seven operators with three lots of Healgen Strep A Rapid Test Strip (Throat Swab), for a total of 21 results for each dilution.
- Interference: Potentially interfering substances (blood, mucus, saliva, and various medications for sore throat) were tested. Each substance was diluted and split into two aliquots: one spiked with S. pyogenes to a final concentration of 1.44 x 10^4 CFU/ml (2xLoD), and the second containing no bacteria. These aliquots were tested with three batches of the device by three laboratory assistants.
- Results: Neither false positive nor false negative results were shown at the tested concentrations.
- Analytical Specificity (Cross-reactivity): Cross-reactivity was evaluated for organisms commonly found in the respiratory tract. Tested by three lots of the device, with three professional users.
- Results: No cross-reactivity was found for the tested organisms at the specified concentrations.
Clinical Studies
- Study Type: Clinical study comparing Healgen Strep A Rapid Test Strip (Throat Swab) with culture studies.
- Sample Size: 368 subjects.
- Key Results:
- Overall Sensitivity: 97.1% (200/206).
- Overall Specificity: 99.4% (161/162).
- Age group performance:
- 0-5 years: Sensitivity 97.4% (74/76), Specificity 98.1% (52/53).
- 5+-21 years: Sensitivity 96.7% (119/123), Specificity 100% (88/88).
- 21+ years: Sensitivity 100% (7/7), Specificity 100% (21/21).
- No statistical differences in performance between age groups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Clinical Sensitivity: 97.1% (95% CI: 93.7%-98.8%)
- Clinical Specificity: 99.4% (95% CI: 96.2%-100.0%)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2022
Healgen Scientific, LLC % Joe Shia Director LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, Maryland 20877
Re: K212623
Trade/Device Name: Healgen Strep A Rapid Test Strip (Throat Swab) Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus Spp. Serological Reagents Regulatory Class: Class I Product Code: GTY Dated: August 16, 2021 Received: August 18, 2021
Dear Joe Shia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar. Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212623
Device Name Strep A Rapid Test Strip (Throat Swab)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) SUMMARY | ||
|---|---|---|
| K212623 | ||
| 1. | Date: | March 7, 2022 |
| 2. | Submitter: | HEALGEN SCIENTIFIC LLC |
| 5213 Maple St | ||
| Bellaire, TX77401 | ||
| 3. | Contact person: | Joe Shia |
| LSI International Inc. | ||
| 504 East Diamond Ave. | ||
| Gaithersburg, MD 20877 | ||
| Telephone: 240-505-7880 | ||
| Email:shiajl@yahoo.com | ||
| 4. | Device Name: | Healgen Strep A Rapid Test Strip (Throat Swab) |
Class I
| Product Code | CFR # | Panel |
|---|---|---|
| GTY | 866.3740 streptococcus spp serological reagents | Microbiology |
-
- Predicate Devices: K133343 Wondfo Strep A Rapid Test Guangzhou Wondfo Biotech Co., Ltd.
Class:
- Predicate Devices: K133343 Wondfo Strep A Rapid Test Guangzhou Wondfo Biotech Co., Ltd.
6. Intended Use/Indications for Use
The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes (Group A B-hemolytic 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 preclude infection 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.
- Device Description
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
4
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.
-
- Substantial Equivalence Information
A summary comparison of features of the Healgen Strep A Rapid Test Strip (Throat Swab) and the predicate device is provided in Table 1.
- Substantial Equivalence Information
| Similarities | ||
|---|---|---|
| Item | Device | Predicate (K133343) |
| Intended Use | For the qualitative detection | |
| of group A streptococcal | ||
| antigen directly from throat | ||
| swabs. | Same | |
| Specimen | Throat swab | Same |
| Assay technical | Immunochromatographic | Same |
| Control Antibodies | Goat polyclonal anti-Rabbit IgG | Same |
| Test Antibody | Rabbit Polyclonal Anti-Strep A | Same |
| Indication for Use | Prescription Use | Same |
| Differences | ||
| Item | Device | Predicate (K133343) |
| Test format | Strip | Cassette |
| Analytical sensitivity | $7.2×10^3$ CFU/mL | 1.5 x $10^5$ organisms/mL |
| Clinical Sensitivity | 97.1%: 95% CI (93.7-98.8%) | 95%: 95% CI (88-98%) |
| Clinical Specificity | 99.4%: 95% CI (96.2-100.0%) | 98%: 95% CI (96-99%) |
| Results Reading Time | 5 minutes | 10 minutes |
-
- Test Principle
Group A Streptococcus reacts with the antibody conjugated to the gold particle. The complex is then bound by the anti-Strep A capture antibody and a visible red test line appears, indicating a positive result. To serve as an onboard procedural control line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly.
- Test Principle
-
- Performance Characteristics
-
- Analytical Performance
- a. Precision/Reproducibility
A test panel consists of a true negative sample (diluent only), a low negative sample (3.6x102 CFU/mL), a moderate positive sample (1.8×10* CFU /mL) and a LoD sample (7.2×103 CFU/mL) were tested. Three lots
5
of the device are used. The study is performed at two runs per day in 5 different days at three different sites. Six professional operators who don't know the sample number code participated in the study (two operators at each site). Each operator tests two runs per day at each concentration with three lots of Healgen Strep A Rapid Test Strip (Throat Swab). A total of 30 determinations by each operator at each concentration are made. The obtained results are shown in the following table.
| Results | Positive Agreement % (Positive/Total tested) | | | Overall Positive
Detection |
|-----------------------------------------------------|----------------------------------------------|--------------|--------------|-------------------------------|
| Samples | Site A | Site B | Site C | |
| True negative sample
(Diluent only) | 0%(0/60) | 0%(0/60) | 0%(0/60) | 0%(0/180) |
| Moderate positive sample,
$1.8\times10^4$ CFU/mL | 100%(60/60) | 100%(60/60) | 100%(60/60) | 100%(180/180) |
| LoD sample,
$7.2\times10^3$ CFU/mL | 98.3%(59/60) | 93.3%(56/60) | 95.0%(57/60) | 95.6%(172/180) |
| Low negative sample,
$3.6\times10^3$ CFU/mL | 48.3%(29/60) | 43.3%(26/60) | 41.7%(25/60) | 44.4%(80/180) |
It's concluded that there are no significant differences of the test results obtained between different users, different sites and different lots in different days. The obtained results are reproducible in good precision.
- b.Linearity
- Not applicable
- c. Stability
Stable at 4-30°C for 24 months based on real time stability determination at both 4°C and 30°C.
d. LoD
The limit of detection (LoD) for the Healgen Strep A Rapid Test Strip was established using limiting dilutions of Streptococcus pyogenes and tested by spiking with clinical matrix. A concentrated stock (3.6 × 107 CFU/mL) of inactivated S. pyogenes ATCC 19615 was serially diluted in saline solution. 5 uL of each contrived dilution sample was pipetted onto negative throat swab clinical matrix for testing. Each dilution was tested by seven operators with three lots of Healgen Strep A Rapid Test Strip (Throat Swab), for a total of 21 results for each dilution. The test results are shown in the following table.
| Table: Determining Limit of Detection (LoD) for Healgen Strep A Rapid Test in clinicalmatrix | |||
|---|---|---|---|
| Dilutions | Number of bacteria loaded*
(5 uL per swab) | Positive/Tested | % Detection |
|----------------|-----------------------------------------------|-----------------|-------------|
| 1.8×105 CFU/mL | 900 | 21/21 | 100% |
| 7.2×104 CFU/mL | 360 | 20/21 | 95.2% |
| 3.6×104 CFU/mL | 180 | 12/21 | 57.6% |
| 1.8×104 CFU/mL | 90 | 1/21 | 4.8% |
| 4.5×103 CFU/mL | 23 | 0/21 | 0% |
*Calculated values based on dilution and volume of sample loaded on the swab per test.
6
The LoD was determined to be 7.2×10* CFU/mL when 5 uL of sample was pipetted onto a negative clinical matrix (equivalent to 360 bacteria on the swab).
The LoD for the Healgen Strep A Rapid Test Strip was also examined by using limiting dilutions of S. pyogenes ATCC 19615 in saline and pipetting 50 uL of each dilution with equivalent bacterial amounts as those used with the clinical matrix onto a swab.
| Dilutions | Number of bacteria loaded*
(50 µL per swab) | Positive/Tested | % Detection |
|----------------|------------------------------------------------|-----------------|-------------|
| 1.8×104 CFU/mL | 900 | 21/21 | 100% |
| 7.2×103 CFU/mL | 360 | 20/21 | 95.2% |
| 3.6×103 CFU/mL | 180 | 11/21 | 47.6% |
| 1.8×103 CFU/mL | 90 | 1/21 | 4.8% |
| 4.5×103 CFU/mL | 23 | 0/21 | 0% |
Table: Determining Detection of Limit (LoD) for Healgen Strep A Rapid Test in Saline Solution
*Calculated values based on dilution and volume of sample loaded on the swab per test.
The LoD was determined to be 7.2×103 CFU/mL when 50 µL of sample was pipetted onto a swab (equivalent to 360 bacteria on the swab) which is consistent with the LoD established using negative throat swab clinical matrix.
e. Interference
The potentially interfering substances of blood, mucus, saliva, and medications used to relieve a sore throat, such as over-the-counter cough drops, lozenges, cough syrups, throat sprays, mouth wash etc. were tested with Healgen Strep A Rapid Test Strip (Throat Swab). Each potentially interfering substance was diluted and splitted into two aliquot was spiked with S. pyogenes to a final concentration of 1.44 x 104 CFU/ml. The second aliquot contained no bacteria. These aliquot samples were tested by three batches of Healgen Strep A Rapid Test Strip (Throat Swab). Three laboratory assistants with relevant experience performed the test. The obtained results are shown in the following table.
| Interfering Substance | Concentration Tested | $1.44 \times 10^4$ CFU/mL S. pyogenes Positive specimen (2×LOD) | S. pyogenes Negative Specimen | ||||
|---|---|---|---|---|---|---|---|
| Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | ||
| Blood (human) | 20% (vol/vol) | + | + | + | - | - | - |
| Mucin | 1mg/mL | + | + | + | - | - | - |
| OTC Mouthwashes | |||||||
| Listerine Antiseptic | 20%(vol/vol) | + | + | + | - | - | - |
| Cool Mint | 20%(vol/vol) | + | + | + | - | - | - |
| Crest Pro-Health Clean Mint | 20%(vol/vol) | + | + | + | - | - | - |
| Crest Pro Health | 20%(vol/vol) | + | + | + | - | - | - |
| Multi Protection Clean Mint | |||||||
| Colgate Total Pro-Shield, | |||||||
| Spearmint | 20%(vol/vol) | + | + | + | - | - | - |
| OTC Lozenges | |||||||
| Sucrets Sore Throat & Cough | |||||||
| Lozenges, Honey Lemon, | 5mg/mL | + | + | + | - | - | - |
| Sucrets Sore Throat | |||||||
| Lozenges Cherry | 5mg/mL | + | + | + | - | - | - |
| Halls Mentho-Lyptus Drops | |||||||
| Cherry | 5mg/mL | + | + | + | - | - | - |
| Halls Cough Suppressant Cherry | |||||||
| Triple Soothing Action | 5mg/mL | + | + | + | - | - | - |
| Cepacol Extra Strength Sore | |||||||
| Throat & Cough Drop Lozenges, | |||||||
| Cherry | 5mg/mL | + | + | + | - | - | - |
| OTC Throat Sprays | |||||||
| Cepacol Dual Relief | 20%(vol/vol) | + | + | + | - | - | - |
| Chloraseptic Max | 20%(vol/vol) | + | + | + | - | - | - |
| OTC Cough Syrups | |||||||
| Tylenol Cough and Sore Throat | 10%(vol/vol) | + | + | + | - | - | - |
| Basic Care Tussin DM, Cough | |||||||
| Suppressant & Expectorant | 10%(vol/vol) | + | + | + | - | - | - |
| Robitussin (Guaifenesin Syrup) | 10%(vol/vol) | + | + | + | - | - | - |
| Robitussin Nighttime Cough | 10%(vol/vol) | + | + | + | - | - | - |
| Children's Dimetapp Cold & Flu | 10%(vol/vol) | + | + | + | - | - | - |
| Children's Dimetapp Cold & | |||||||
| Cough | 10%(vol/vol) | + | + | + | - | - | - |
| Active Ingredients | |||||||
| Acetaminophen (Tylenol) | 5mg/mL | + | + | + | - | - | - |
| Brompheniramine Maleate | 5mg/mL | + | + | + | - | - | - |
| Chlorpheniramine Maleate | 5mg/mL | + | + | + | - | - | - |
| Dextromethorphan HBr | 5mg/mL | + | + | + | - | - | - |
| Diphenhydramine HCI | 5mg/mL | + | + | + | - | - | - |
| Doxylamine Succinate | 5mg/mL | + | + | + | - | - | - |
| Guaifenesin(Guaiacol Glyceryl) | 5mg/mL | + | + | + | - | - | - |
| Ibuprofen (Advil) | 5mg/mL | + | + | + | - | - | - |
| Phenylephrine HCI | 5mg/mL | + | + | + | - | - | - |
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Neither false positive nor false negative results are shown in the Healgen Strep A Rapid Test Strip (Throat Swab) at the concentrations listed.
- f. Analytical Specificity
Analytical specificity (cross-reactivity) of Healgen Strep A Rapid Test Strip (Throat Swab) was carried out for organisms likely to be found in the respiratory tract. It was tested by three lots of Healgen Strep A Rapid Test Strip (Throat Swab). Three professional users performed the test. The obtained results are summarized in the following table.
| Test results | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Organisms | Concentration | |||||||||
| Tested | Lot1# | Lot2# | Lot3# | |||||||
| Operator | ||||||||||
| A | Operator | |||||||||
| B | Operator | |||||||||
| C | Operator | |||||||||
| A | Operator | |||||||||
| B | Operator | |||||||||
| C | Operator | |||||||||
| A | Operator | |||||||||
| B | Operator | |||||||||
| C | ||||||||||
| Arcanobacterium | ||||||||||
| haemolyticum | 2.6×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Bordetella pertussis | 7.5×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Candida albicans | 9.5×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Corynebacterium | ||||||||||
| diphtheria | 5.37×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Enterococcus faecalis | 2.3×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Enterococcus faecium | 4.4×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Enterovirus (VR-28 | ||||||||||
| Human | ||||||||||
| Coxsackievirus) | 1.6×108 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Escherichia coli | 1.1×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Fusobacterium | ||||||||||
| necrophorum | 7.3×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Haemophilus | ||||||||||
| parahaemolyticus | 1.3×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Haemophilus influenzae | 4.5×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Haemophilus | ||||||||||
| parainfluenzae | 1.6×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Human | ||||||||||
| metapneumovirus | ||||||||||
| (HMPV-27 A2) | 3.55×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Human coronavirus | ||||||||||
| OC43 | 1.7×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Klebsiella pneumoniae | 3.1×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Legionella pneumophila | 1×104 bacteria/mL | - | - | - | - | - | - | - | - | - |
9
| Lactobacillus sp.
| (Lactobacillus casei) | 6.5×108 CFU/mL | - | - | - | - | - | - | - |
|---|---|---|---|---|---|---|---|---|
| Mycobacterium | ||||||||
| tuberculosis | 1×103 bacteria/mL | - | - | - | - | - | - | - |
| Moraxella lacunata | 1.95×108 CFU/mL | - | - | - | - | - | - | - |
| Moraxella | ||||||||
| (Branhamella) | ||||||||
| catarrhalis | 4.8×108 CFU/mL | - | - | - | - | - | - | - |
| Mycobacterium | ||||||||
| tuberculosis | ||||||||
| (avirulent strain) | 2.3×108 CFU/mL | - | - | - | - | - | - | - |
| Neisseria gonorrhoeae | 3.8×108 CFU/mL | - | - | - | - | - | - | - |
| Neisseria lactamica | 1.19×108 CFU/mL | - | - | - | - | - | - | - |
| Neisseria meningitides | 7.5×108 CFU/mL | - | - | - | - | - | - | - |
| Neisseria mucosa | 3.25×108 CFU/mL | - | - | - | - | - | - | - |
| Neisseria sicca | 8.5×108 CFU/mL | - | - | - | - | - | - | - |
| Neisseria subflava | 3.27×108 CFU/mL | - | - | - | - | - | - | - |
| Proteus vulgaris | 2.9×108 CFU/mL | - | - | - | - | - | - | - |
| Pseudomonas | ||||||||
| aeruginosa | 5.1×108 CFU/mL | - | - | - | - | - | - | - |
| Serratia marcescens | 2.1×108 CFU/mL | - | - | - | - | - | - | - |
| Staphylococcus aureus | 3.2×108 CFU/mL | - | - | - | - | - | - | - |
| Staphylococcus | ||||||||
| epidermidis | 2.1×108 CFU/mL | - | - | - | - | - | - | - |
| Staphylococcus | ||||||||
| marcescens | 1.5×108 CFU/mL | - | - | - | - | - | - | - |
| Staphylococcus | ||||||||
| haemolyticus | 1.58×108 CFU/mL | - | - | - | - | - | - | - |
| Streptococcus agalactiae | ||||||||
| (Group B) | 7.9×107 CFU/mL | - | - | - | - | - | - | - |
| Streptococcus | ||||||||
| dysgalactiae (Group C) | 1.43×105CFU/mL | - | - | - | - | - | - | - |
| Streptococcus sp. (bovis | ||||||||
| II) Group D | 5.6×108 CFU/mL | - | - | - | - | - | - | - |
| Streptococcus sp. Strain | 1×106 CFU/mL | - | - | - | - | - | - | - |
10
| H60R (Group F) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Streptococcus anginosus | ||||||||||
| (Group G) | 4.2×107 CFU/mL | - | - | - | - | - | - | - | - | - |
| Streptococcus | ||||||||||
| pneumoniae | 4.2×106 CFU/mL | - | - | - | - | - | - | - | - | - |
| Streptococcus salivarius | 8.7×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Streptococcus mitis | 5.9×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Streptococcus mutans | 4.7×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Streptococcus oralis | 6.4×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Streptococcus sanguis | 1.5×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Yersinia enterocolitica | 2.0×108 CFU/mL | - | - | - | - | - | - | - | - | - |
| Adenovirus Type I | 3.09×108 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Adenovirus Type II | 3.9×107 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Adenovirus 3 | 1.5×108 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Adenovirus 7 | 2.8×106 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Cytomegalovirus | 1.6×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Epstein Barr Virus | 7.85×107 copies/mL | - | - | - | - | - | - | - | - | - |
| HSV Type 1 MacIntyre | ||||||||||
| strain | 1.6×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Human parainfluenza | ||||||||||
| Type 1 | 1.6×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Human parainfluenza | ||||||||||
| Type 2 | 1.6×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Human parainfluenza | ||||||||||
| Type 3 | 1.6×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Human rhinovirus 26 | 5×106 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Measles Virus | 8.9×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Mumps virus | 1.38×107 TCID50/mL | - | - | - | - | - | - | - | - | - |
| Respiratory syncytial | ||||||||||
| virus Type A | 5.5×107 PFU/mL | - | - | - | - | - | - | - | - | - |
| Respiratory syncytial | ||||||||||
| virus Type B | 2.8×105 TCID50/mL | - | - | - | - | - | - | - | - | - |
No cross reactivity was found for the above organisms at the concentrations tested.
11
-
- Comparison Studies
NA
- Comparison Studies
3. Clinical Studies
A total of 368 subjects were tested from patients exhibiting symptoms of pharyngitis by both the Healgen Strep A Rapid Test Strip (Throat Swab) and the culture studies. Of the 368 total subjects, 162 were found to be negative (-) by culture and 206 were found to be positive (+) by culture. These test results are summarized in the following tables.
| ALL AGES | |||
|---|---|---|---|
| Strep A Rapid Test Strip | |||
| (Throat Swab) | Culture Result | Total | |
| + | - | ||
| + | 200 | 1 | 201 |
| - | 6 | 161 | 167 |
| Total | 206 | 162 | 368 |
| Age | Sensitivity | Sensitivity(95%CI) | Specificity | Specificity(95%CI) |
|---|---|---|---|---|
| 0~5 | 97.4% (74/76) | 90.4% - 99.8% | 98.1% (52/53) | 89.1% - 100.0% |
| 5+~21 | 96.7% (119/123) | 91.7% - 99.0% | 100% (88/88) | 95.0% - 100.0% |
| 21+ | 100% (7/7) | 59.6% - 100.0% | 100% (21/21) | 81.8% - 100.0% |
| All | 97.1% (200/206) | 93.7% - 98.8% | 99.4% (161/162) | 96.2% - 100.0% |
There were no statistical differences in the Healgen Strep A Rapid Test Strip (Throat Swab) performance between the age groups. The overall Clinical Sensitivity is 97%. The overall clinical specificity is 99%.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, LoD, interference, specificity and clinical study of the device, it's concluded that Healgen Strep A Rapid Test Strip (Throat Swab) is substantially equivalent to the predicate.