(93 days)
The Wondfo Strep A Rapid Test is a chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens from symptomatic patients to aid in the diagnosis of Group A Streptococcal Infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use, only.
For in vitro diagnostic use For prescription Use only
Wondfo One Step Strep A Swab Test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen directly from a throat swab sample. To perform the test. Reagent 1 (R 1) is added to the extraction tube which is coated with a mixture of conjugate antibodies and a lytic enzyme extraction reagent.
The lytic enzyme is mixed with colloidal gold conjugated to rabbit anti-Strep A and a second colloidal gold control conjugate antibody. The reagents are dried onto the bottom of an extraction tube forming a red spot. The extraction/conjugate pellet is re-suspended with RI and the throat swab is added to the extraction tube. The Strep A antigen is extracted from the sample and the swab is removed. The test strip is immediately placed in the extracted sample.
If Group A Streptococcus is present in the sample, it will react with the anti-Strep A antibody conjugated to the gold particle. The complex will then be bound by the anti-Strep A capture antibody and a visible red test line will appear, indicating a positive result. To serve as an onboard procedural control, the blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly. If Strep A antigen is not present, or present at very low levels, only a red control line will appear. If the red control line does not appear, or remains blue, the test result is invalid.
Acceptance Criteria and Study for Wondfo One Step Strep A Swab Test
This document outlines the acceptance criteria and the performance study for the Wondfo One Step Strep A Swab Test, a chromatographic immunoassay for the qualitative detection of Strep A antigen.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Clinical Sensitivity (All Ages) | - Implied to be clinically acceptable (compared to predicate device's 96.2%) | 95% (95% CI: 88%-98%) |
| Clinical Specificity (All Ages) | - Implied to be clinically acceptable (compared to predicate device's 98.7%) | 98% (95% CI: 96%-99%) |
| Precision (C95 Concentration) | 95.0% detection at C95 concentration | Overall Detection: 95.0% (171/180) |
| Precision (Moderate Positive) | 100% detection | Overall Detection: 100% (180/180) |
| Precision (True Negative) | 0% detection (no false positives) | Overall Detection: 0% (0/180) |
| Analytical Sensitivity (Cut-off) | Defined as the concentration at 95% detection | 1.5 x 10^5 organisms/mL (95.2% detection) |
| Interference | No false positives or false negatives observed with tested substances at specified concentrations | No false positive or false negative results shown at tested concentrations |
| Analytical Specificity (Cross-reactivity) | No cross-reactivity with tested organisms at 1x10^8 organisms/mL | No cross-reactivity found for listed organisms |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study): A total of 349 throat swabs were collected.
- 101 culture-positive specimens.
- 248 culture-negative specimens.
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as samples were "collected from patients exhibiting symptoms of pharyngitis" and then tested by both culture and the Wondfo device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth for the clinical study was established by bacterial culture on sheep blood agar plates. It is a laboratory-based method of detecting bacterial presence, not based on expert interpretation of images or observations.
- Therefore, the concept of "number of experts" and "qualifications of those experts" in the traditional sense of medical image interpretation (e.g., radiologists) is not applicable here. The culture results are considered the objective ground truth.
4. Adjudication Method for the Test Set
- The ground truth was established by bacterial culture. This is an objective laboratory method, and thus, an adjudication method for reconciling differing results between experts is not applicable. The culture result is a definitive positive or negative.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly done. This study assesses the performance of a diagnostic device (rapid test) against a gold standard (bacterial culture), not how human readers improve with or without AI assistance.
- The document does not mention any AI component or human-in-the-loop assistance in the context of improving human reader performance.
6. Standalone Performance Study
- Yes, a standalone study was done. The entire clinical performance section (Section 10.3) details the performance of the Wondfo One Step Strep A Swab Test as an algorithm/device only, without human-in-the-loop performance being a variable. The rapid test results were directly compared to the bacterial culture results.
7. Type of Ground Truth Used
- The primary ground truth used for the clinical study was bacterial culture.
- For the analytical performance studies (precision, cut-off, interference, specificity), the ground truth was established using known concentrations of inactivated Streptococcus pyogenes or other specified organisms/substances.
8. Sample Size for the Training Set
- The document does not provide information on a specific training set or its sample size. This is a rapid diagnostic test, not a machine learning algorithm that typically requires a distinct training phase. All listed performance characteristics studies (analytical and clinical) appear to be validation or test sets for the finished device.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned for a machine learning model, the method for establishing its ground truth is not applicable in this context. The established ground truth for the analytical and clinical studies were bacterial culture and known concentrations of organisms/substances.
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510(k) SUMMARY
| 1. Date: | January 15, 2014 | JAN 31 2014 | ||
|---|---|---|---|---|
| 2. Submitter: | Guangzhou Wondfo Biotech Co., Ltd.South China University of TechnologyGuangzhou, P.R. China 510641 | |||
| 3. Contact person: | Joe ShiaLSI International Inc.504 East Diamond Ave., Suite FGaithersburg, MD 20878Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com | |||
| 4. Device Name: | Wondfo One Step Strep A Swab Test |
- Class:
Class I
| ProductCode | CFR # | Panel |
|---|---|---|
| GTY | 866.3740 Streptococcus spp. serologicalreagents | 83 Microbiology |
-
- Predicate Devices:
K040708 Status First Strep A Princeton Biomedtech Co.
- Predicate Devices:
-
- Intended Use/Indications for Use
The Wondfo Strep A Rapid Test is a chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens from symptomatic patients to aid in the diagnosis of Group A Streptococcal Infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use, only.
- Intended Use/Indications for Use
For in vitro diagnostic use For prescription Use only
{1}------------------------------------------------
7. Device Description
Wondfo One Step Strep A Swab Test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen directly from a throat swab sample. To perform the test. Reagent 1 (R 1) is added to the extraction tube which is coated with a mixture of conjugate antibodies and a lytic enzyme extraction reagent.
The lytic enzyme is mixed with colloidal gold conjugated to rabbit anti-Strep A and a second colloidal gold control conjugate antibody. The reagents are dried onto the bottom of an extraction tube forming a red spot. The extraction/conjugate pellet is re-suspended with RI and the throat swab is added to the extraction tube. The Strep A antigen is extracted from the sample and the swab is removed. The test strip is immediately placed in the extracted sample.
If Group A Streptococcus is present in the sample, it will react with the anti-Strep A antibody conjugated to the gold particle. The complex will then be bound by the anti-Strep A capture antibody and a visible red test line will appear, indicating a positive result. To serve as an onboard procedural control, the blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly. If Strep A antigen is not present, or present at very low levels, only a red control line will appear. If the red control line does not appear, or remains blue, the test result is invalid.
-
- Substantial Equivalence Information
A summary comparison of features of the Wondfo One Step Strep A Swab Test and the predicate device is provided in Table 1.
- Substantial Equivalence Information
| Similarities | ||||
|---|---|---|---|---|
| Item. | Device (K133343) | Predicate (K040708) | ||
| Intended Use | For the qualitative detectionof group A streptococcalantigen directly from throatswabs. | Same | ||
| Specimen | Throat swab | Same | ||
| Assay technical | Immunochromatographic | Same | ||
| Test Antibody | Rabbit Polyclonal Anti-Strep A | Same | ||
| Analytical sensitivity | 1.5 x 105 organisms/mL | Same | ||
| Indication for Use | Prescription Use | Same |
7
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| Differences | ||
|---|---|---|
| Item | Device (K133343) | Predicate (K040708) |
| Control Antibodies | Goat polyclonal anti-Strep A | Rabbit polyclonal anti-Strep A |
| Clinical Sensitivity | 95%: 95% CI (88-98%) | 96.2%: 95% CI (95-98.9%) |
| Clinical Specificity | 98%: 95% CI (96-99%) | 98.7%: 95% CI (98-100%) |
| Wait Time for ResultsRead | 10 minutes | 5 minutes |
| Extraction Method | Extraction performed in atest tube and transferred to testdevice | Extraction performedwithin extraction wells in thetest device |
9. Test Principle
Group A Streptococcus reacts with the anti-Strep A 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, a blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly.
10. Performance Characteristics
-
- Analytical Performance
- a. Precision/Reproducibility
A test panel consists of a true negative sample (diluent only), a moderate positive sample (2.3×106 organisms /mL), a cut-off sample (1.5×105 organisms /mL, C95 concentration, approximately positive 95% of the time), and a low negative sample (0.4x10 organisms /mL) were tested. Three lots 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 Wondfo One Step Strep A Swab Test. A total of 30 determinations by each operator at each concentration are made. The obtained results are shown in the following table.
| Results | Site A detection | Site B detection | Site C detection | OverallDetection |
|---|---|---|---|---|
| Samples | ||||
| Diluent (true negative) | 0% (0/60) | 0% (0/60) | 0% (0/60) | 0% (0/180) |
| $2.3\times10^6$ (moderate positive) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (180/180) |
| $1.5\times10^5$ (C95 concentration) | 98.3% (59/60) | 95.0% (57/60) | 91.9% (55/60) | 95.0% (171/180) |
| $0.4x10^5$ (low negativesample) | 43.3% (26/60) | 55.0% (33/60) | 33.3% (20/60) | 43.9% (79/180) |
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It is 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 18 months based on the accelerated stability study at 50°C and real time stability determination at both 4℃ and 30℃.
- d. Cut-off
A concentrated stock (2.3x107 organisms/mL) of inactivated Streptococcus pyogenes (ATCC #20159) is serially diluted in the solution of extraction reagents. Each dilution is tested by seven operators with three batches of Wondfo One Step Strep A Swab Test respectively. A total of 21 determinations at each dilution were made. The test results are shown in the following table.
| Levels (organisms /mL) | $2.3x10^6$ | $1.5x10^5$ | $0.8x10^5$ | $0.4x10^5$ | $1x10^3$ |
|---|---|---|---|---|---|
| Positive # | 21 | 20 | 16 | 10 | 0 |
| Negative # | 0 | 1 | 5 | 11 | 18 |
| % Detection | 100 | 95.2 | 76.2 | 47.6 | 0 |
The assay cut-off of Wondfo One Step Strep A Swab Test is 1.5x105 organisms/mL.
- 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 Wondfo One Step Strep A Swab Test. Each potentially interfering substance was diluted and splitted into two aliquots. One aliquot was spiked with S. pyogenes to a final concentration of 2.3 x 10° organisms/ml. The second aliquot contained no bacteria. These aliquot samples were tested by three batches of Wondfo One Step Strep A Swab Test. Three laboratory assistants with relevant experience performed the test. The obtained results are shown in the following table.
| Substance | ConcentrationTested | 2.3×106 CFU/mLS. pyogenes Specimen | S. pyogenesNegative Specimen | ||||
|---|---|---|---|---|---|---|---|
| Lot I | Lot II | Lot III | Lot I | Lot II | Lot III | ||
| Mucin (BovineSubmaxillary Gland, typeI-S) | 60 µg/mL | + | + | + | - | - | - |
| Blood (human), EDTAanticoagulated | 2% (vol/vol) | + | + | + | - | - | - |
| OTC Mouthwashes | |||||||
| Listerine Antiseptic | 20%(vol/vol) | + | + | + | - | - | - |
| Listerine Cool Mint | 20%(vol/vol) | + | + | + | - | - | - |
| Crest Pro-Health CleanNight Mint | 20%(vol/vol) | + | + | + | - | - | - |
| OTC Lozenges | |||||||
| Sucrets Complete (CoolCitrus) | 10%(vol/vol) | + | + | + | - | - | - |
| Halls Cherry Mentholyptus | 10%(vol/vol) | + | + | + | - | - | - |
| Halls Plus Mentholyptus | 10%(vol/vol) | + | + | + | - | - | - |
| Cepacol Cherry Sore Throat | 10%(vol/vol) | + | + | + | - | - | - |
| OTC Throat Sprays | |||||||
| Cepacol Dual Relief | 20%(vol/vol) | + | + | + | - | - | - |
| Chloraseptic Max | 20%(vol/vol) | + | + | + | - | - | - |
| OTC Cough Syrups | |||||||
| Tylenol Cough and SoreThroat | 10%(vol/vol) | + | + | + | - | - | - |
| Tussin (Guaifenesin Syrup)Rite | 0.1%(vol/vol) | + | + | + | - | - | - |
| Robitussin (GuaifenesinSyrup) | 1%(vol/vol) | + | + | + | - | - | - |
| Robitussin Nighttime Cough | 10%(vol/vol) | + | + | + | - | - | - |
| Children's Dimetapp CoughPlus | 10%(vol/vol) | + | + | + | - | - | - |
| Children's Dimetapp DMElixir | 10%(vol/vol) | + | + | + | - | - | - |
| Active Ingredients | |||||||
| Acetaminophen (Tylenol) | 10mg/mL | + | + | + | - | - | - |
| Brompheniramine Maleate | 5mg/mL | + | + | + | - | - | - |
| Chlorpheniramine Maleate | 5mg/mL | + | + | + | - | - | - |
| Dextromethorphan HBr | 5mg/mL | + | + | + | - | - | - |
| Diphenhydramine HCI | 5mg/mL | + | + | + | - | - | - |
| Doxylamine Succinate | 1mg/mL | + | + | + | - | - | - |
| Guaifenesin (GuaiacolGlyceryl) | 20mg/mL | + | + | + | - | - | - |
| Ibuprofen (Advil) | 10mg/mL | + | + | + | - | - | - |
| Phenylephrine HCI | 5mg/mL | + | + | + | - | - | - |
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Neither false positive nor false negative results are shown in the Wondfo One Step Strep A Swab Test at the concentrations listed.
An additional study was performed to investigate the potential of Agar Interference on the performance of the Wondfo One Step Strep A Swab Test. Results showed 100% agreement between culture and rapid test results, suggesting that agar did not interfere
{5}------------------------------------------------
with the performance of the Wondfo Strep A test.
- f. Analytical Specificity
Analytical specificity (cross-reactivity) of Wondfo One Step Strep A Swab Test was carried out for organisms likely to be found in the respiratory tract at 1x108 organisms per mL concentration. It was tested by three lots of Wondfo One Step Strep A Swab Test. Three professional users performed the test. The obtained results are summarized in the following table.
| Results | Lot I | Lot II | Lot III | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Organisms | V.1 | V.2 | V.3 | V.1 | V.2 | V.3 | V.1 | V.2 | V.3 |
| Streptococcus Group B | - | - | - | - | - | - | - | - | - |
| Streptococcus Group C | - | - | - | - | - | - | - | - | - |
| Streptococcus Group F | - | - | - | - | - | - | - | - | - |
| Streptococcus Group G | - | - | - | - | - | - | - | - | - |
| Streptococcus salivarius | - | - | - | - | - | - | - | - | - |
| Streptococcus anginosus. | - | - | - | - | - | - | - | - | - |
| Streptococcus mitis | - | - | - | - | - | - | - | - | - |
| Streptococcus mutans | - | - | - | - | - | - | - | - | - |
| Streptococcus oralis | - | - | - | - | - | - | - | - | - |
| Streptococcus pneumoniae | - | - | - | - | - | - | - | - | - |
| Streptococcus sanguis | - | - | - | - | - | - | - | - | - |
| Arcanobacterium haemolyticum | - | - | - | - | - | - | - | - | - |
| Bordetella pertussis | - | - | - | - | - | - | - | - | - |
| Branhamella catarrhalis | - | - | - | - | - | - | - | - | - |
| Candida albicans | - | - | - | - | - | - | - | - | - |
| Corynebacterium diphtheriae | - | - | - | - | - | - | - | - | - |
| Enterococcus faecalis | - | - | - | - | - | - | - | - | - |
| Enterococcus faecium | - | - | - | - | - | - | - | - | - |
| Escherichia coli | - | - | - | - | - | - | - | - | - |
| Fusobacterium necrophorum | - | - | - | - | - | - | - | - | - |
| Haemophilus parahaemolyticus | - | - | - | - | - | - | - | - | - |
| Haemophilus parainfluenzae | - | - | - | - | - | - | - | - | - |
| Haemophilus influenzae | - | - | - | - | - | - | - | - | - |
| Klebsiella pneumoniae | - | - | - | - | - | - | - | - | - |
| Moraxella catarrhalis | - | - | - | - | - | - | - | - | - |
| Moraxella lacunata | - | - | - | - | - | - | - | - | - |
| Neisseria gonorrhoeae | - | - | - | - | - | - | - | - | - |
| Neisseria lactamica | - | - | - | - | - | - | - | - | - |
| Neisseria meningitides | - | - | - | - | - | - | - | - | - |
| Neisseria mucosa | - | - | - | - | - | - | - | - | - |
| Neisseria sicca | - | - | - | - | - | - | - | - | - |
| Neisseria subflava | - | - | - | - | - | - | - | - | - |
| Proteus vulgaris | - | - | - | - | - | - | - | - | - |
| Results | Lot | l | Lot II | Lot III | |||||
| Organisms | V. 1 | V.2 | V.3 | V. 1 | V.2 | V.3 | V. 1 | V.2 | V.3 |
| Pseudomonas aeruginosa | |||||||||
| Serratia marcescens | |||||||||
| Staphylococcus marcescens | |||||||||
| Staphylococcus aureus | |||||||||
| Staphylococcus epidermidis | |||||||||
| Staphylococcus haemolyticus | |||||||||
| Yersinia enterocolitica | |||||||||
| Lactobacillus sp. (Lactobacillus casei) | |||||||||
| Mycobacterium tuberculosis (avirulent | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | |||||||
| strain) | |||||||||
| Streptococcus sp. (bovis II) Group D | |||||||||
| Adenovirus Type 1 | - | ||||||||
| Denovirus Type II | - | ||||||||
| Cytomegalovirus | - | ||||||||
| Enterovirus (VR-28 Human Coxsackievirus) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||||||||
| Epstein Barr Virus | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||||||||
| HSV Type I MacIntyre strain | |||||||||
| Human coronavirus OC43 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||||||||
| Human metapneumovirus (hMPV-27 A2) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | |||||||
| Human parainfluenza Type 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---- | |||||||
| Human parainfluenza Type 2 | - | ||||||||
| Human parainfluenza Type 3 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||||||||
| Human parainfluenza Type 4 | - | - | |||||||
| Measles | - | ||||||||
| Mumps virus | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | |||||||
| Respiratory syncytial virus VR-26 | - | ||||||||
| Rhinovirus |
{6}------------------------------------------------
Note: V.1: the first viewer; V.2: the second viewer; V.3: the third viewer.
No cross reactivity was found for the above organisms at the concentration of 1 ×10° organisms/mL.
-
- Comparison Studies
Not applicable
- Comparison Studies
-
- Clinical Studies
A total of 349 throat swabs were collected from patients exhibiting symptoms of pharyngitis. Each swab was rolled onto a sheep blood agar plate for culture tests, and then tested by the Wondfo One Step Strep A Swab Test. Of the 349 total specimens, 248 were found to be negative (-) by culture and 101 were found to be positive (+) by culture. These test results are summarized in the following tables.
- Clinical Studies
{7}------------------------------------------------
Clinical Performance Characteristics
| ALL AGES | |||
|---|---|---|---|
| Wondfo | Culture (+) | Culture (□) | TOTAL |
| + | 96 | 4 | 100 |
| - | 5 | 244 | 249 |
| TOTAL | 101 | 248 | 349 |
| Age | Sensitivity | Sensitivity (95% CI) | Specificity | Specificity (95% CI) |
|---|---|---|---|---|
| 0-5 | 84% | 60%-96% | 100% | 87%-100% |
| 5-21 | 97% | 88%-99% | 98% | 93%-99% |
| 21+ | 100% | 80%-100% | 99% | 92%-100% |
| All | 95% | 88%-98% | 98% | 96%-99% |
There were no statistical differences in the Wondfo One Step Strep A Swab Test performance between the age groups. The overall Clinical Sensitivity is 95%. The overall clinical specificity is 98%.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and clinical study of the device, it iss concluded that Wondfo One Step Strep A Swab Test is substantially equivalent to the predicate.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 31, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Guangzhou Wondfo Biotech Co., Ltd c/o Joe Shia, Consultant LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878
Re: K133343
Trade/Device Name: Wondfo® One Step Strep A Swab Test Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. Serological Reagent Regulatory Class: Class I Product Code: GTY Dated: December 11, 2013 Received: December 13, 2013
Dear Mr. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{9}------------------------------------------------
Page 2 - Mr. Joe Shia
:11:00:00 来源:
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office. of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDeviccs/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe schiert -S for
Sally A. Hojvat. M.Sc.. Ph.D: Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133343
Device Name Wondfo One Step Strep A Swab Test
Indications for Use (Describe)
The Wordfo Strep A Rapid Test is a chromatographic intrumossay for the qualitative detection of Strep A antigen from throal swab specimens from symptomatic patients to aid in the diggiosis of Group A Streptococcal Infection. All negative test results should be confirmed by bacterial culture because negative esults do not prechede Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use, only.
For in vitro diagnostic use
For preseription Use only
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 Subpan C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR CONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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.