Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a lateral flow immunoassay based on chemical reactions and visual interpretation of lines, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) test for detecting Strep A antigen; it provides diagnostic information, but does not directly treat or prevent a disease.

Diagnostic

Yes
The device is described as aiding in the diagnosis of Group A Streptococcal Infection, and it detects a Strep A antigen from throat swab specimens from symptomatic patients, which are characteristics of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, lateral flow immunoassay kit involving reagents, extraction tubes, swabs, and test strips. This is a hardware-based in vitro diagnostic device, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is 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." This clearly indicates a diagnostic purpose.
"For in vitro diagnostic use": This phrase is explicitly stated in the "Intended Use / Indications for Use" section, which is a direct confirmation of its IVD status.
Sample Type: The device uses "throat swab specimens," which are biological samples taken from the human body for analysis outside of the body (in vitro).
Detection of Analyte: It detects "Strep A antigen," which is a specific biological marker related to a disease.
Aid in Diagnosis: The test is intended to "aid in the diagnosis" of Group A Streptococcal Infection, which is a key function of an IVD.
Professional and Laboratory Use: While not a definitive requirement for all IVDs, the intended user and setting (professional and laboratory) are consistent with the use of diagnostic tests.

All of these factors align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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. For in vitro diagnostic use For prescription Use only

Product codes (comma separated list FDA assigned to the subject device)

GTY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Throat

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional and laboratory 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, moderate positive, cut-off, and low negative sample was tested. Three lots of the device were used. Study performed at two runs per day for 5 days at three different sites by six professional operators (two operators per site). Total of 30 determinations by each operator at each concentration.
Results:
- Diluent (true negative): 0% (0/180) detection overall
- 2.3x10^6 organisms/mL (moderate positive): 100% (180/180) detection overall
- 1.5x10^5 organisms/mL (C95 concentration): 95.0% (171/180) detection overall
- 0.4x10^5 organisms/mL (low negative sample): 43.9% (79/180) detection overall
Conclusion: No significant differences in test results between users, sites, or lots in different days. Results are reproducible with good precision.
Stability: Stable at 4-30°C for 18 months based on accelerated stability study at 50°C and real-time stability determination at 4℃ and 30℃.
Cut-off: Inactivated Streptococcus pyogenes (ATCC #20159) was serially diluted. Each dilution tested by seven operators with three batches of Wondfo One Step Strep A Swab Test. Total of 21 determinations per dilution.
Results:
- 2.3x10^6 organisms/mL: 100% detection (21 positive, 0 negative)
- 1.5x10^5 organisms/mL: 95.2% detection (20 positive, 1 negative)
- 0.8x10^5 organisms/mL: 76.2% detection (16 positive, 5 negative)
- 0.4x10^5 organisms/mL: 47.6% detection (10 positive, 11 negative)
- 1x10^3 organisms/mL: 0% detection (0 positive, 18 negative)
Conclusion: The assay cut-off is 1.5x10^5 organisms/mL.
Interference: Potentially interfering substances (blood, mucus, saliva, medications) were tested. Aliquots were spiked with S. pyogenes (2.3 x 10^6 organisms/ml) or contained no bacteria. Tested with three batches by three laboratory assistants.
Conclusion: Neither false positive nor false negative results shown at the concentrations listed. Agar did not interfere with performance (100% agreement with culture).
Analytical Specificity (Cross-reactivity): Organisms likely to be found in the respiratory tract were tested at 1x10^8 organisms/mL concentration. Tested by three lots by three professional users.
Conclusion: No cross-reactivity found for the tested organisms at the specified concentration.
Comparison Studies: Not applicable.
Clinical Studies:
A total of 349 throat swabs from patients with pharyngitis symptoms were collected. Each swab was cultured on a sheep blood agar plate and also tested by the Wondfo One Step Strep A Swab Test. Of the 349 specimens, 248 were culture-negative and 101 were culture-positive.
Clinical Performance Characteristics (ALL AGES):
- Wondfo positive, Culture positive: 96
- Wondfo positive, Culture negative: 4
- Wondfo negative, Culture positive: 5
- Wondfo negative, Culture negative: 244
Age-specific results:
- 0-5 years: Sensitivity 84% (95% CI: 60%-96%), Specificity 100% (95% CI: 87%-100%)
- 5-21 years: Sensitivity 97% (95% CI: 88%-99%), Specificity 98% (95% CI: 93%-99%)
- 21+ years: Sensitivity 100% (95% CI: 80%-100%), Specificity 99% (95% CI: 92%-100%)
Overall Results: Overall Clinical Sensitivity is 95% (95% CI: 88%-98%). Overall clinical specificity is 98% (95% CI: 96%-99%).
Conclusion: No statistical differences in performance between age groups.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Overall Clinical Sensitivity is 95%. The overall clinical specificity is 98%.

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.

K040708

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

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.

Summary

0

K133343

510(k) SUMMARY

	1. Date:	January 15, 2014
	2. Submitter:	Guangzhou Wondfo Biotech Co., Ltd.
South China University of Technology
Guangzhou, P.R. China 510641
	3. Contact person:	Joe Shia
LSI International Inc.
504 East Diamond Ave., Suite F
Gaithersburg, MD 20878
Telephone: 240-505-7880
Fax: 301-916-6213
Email:shiajl@yahoo.com
	4. Device Name:	Wondfo One Step Strep A Swab Test

Class:
Class I

| Product

Code	CFR #	Panel
GTY	866.3740 Streptococcus spp. serological
reagents	83 Microbiology

1. Predicate Devices:
  K040708 Status First Strep A Princeton Biomedtech Co.
1. 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.

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.

1. 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.

Similarities
Item.

          | Device ([K133343](https://510k.innolitics.com/search/K133343))                                                                                    | Predicate ([K040708](https://510k.innolitics.com/search/K040708)) |  |  |

7

2

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 Results
Read	10 minutes	5 minutes
Extraction Method	Extraction performed in a
test tube and transferred to test
device	Extraction performed
within extraction wells in the
test 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

1. 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 | Overall
Detection |
|-------------------------------------|------------------|------------------|------------------|----------------------|
| 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 negative
sample) | 43.3% (26/60) | 55.0% (33/60) | 33.3% (20/60) | 43.9% (79/180) |

3

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 Tested | 2.3×106 CFU/mL
S. pyogenes Specimen | Negative Specimen | | |------------------------ | | Mucin (Bovine
Submaxillary Gland, type
I-S) | 60 µg/mL | Blood (human), EDTA
anticoagulated | OTC Mouthwashes | Listerine Antiseptic | Listerine Cool Mint | Crest Pro-Health Clean
Night Mint | OTC Lozenges | Sucrets Complete (Cool
Citrus) | Halls Cherry Mentholyptus | Halls Plus Mentholyptus | Cepacol Cherry Sore Throat | OTC Throat Sprays | Cepacol Dual Relief | Chloraseptic Max | OTC Cough Syrups | Tylenol Cough and Sore
Throat | Tussin (Guaifenesin Syrup)
Rite | Robitussin (Guaifenesin
Syrup) | Robitussin Nighttime Cough | Children's Dimetapp Cough
Plus | Children's Dimetapp DM
Elixir | Active Ingredients | Acetaminophen (Tylenol) | Brompheniramine Maleate | Chlorpheniramine Maleate | Dextromethorphan HBr | Diphenhydramine HCI | Doxylamine Succinate | Guaifenesin (Guaiacol
Glyceryl) | Ibuprofen (Advil) | Phenylephrine HCI | Concentration
| | S. pyogenes
|
---------------------------|-------------------------|-----------------------------------------------|--------|---------|-----------------------------------------|--------|---------|
| | Lot I | Lot II | Lot III | Lot I | Lot II | Lot III |
| + | + | + | - | - | - |
| 2% (vol/vol) | + | + | + | - | - | - |
| | | | | | | |
| 20%(vol/vol) | + | + | + | - | - | - |
| 20%(vol/vol) | + | + | + | - | - | - |
| 20%(vol/vol) | + | + | + | - | - | - |
| | | | | | | |
| 10%(vol/vol) | + | + | + | - | - | - |
| 10%(vol/vol) | + | + | + | - | - | - |
| 10%(vol/vol) | + | + | + | - | - | - |
| 10%(vol/vol) | + | + | + | - | - | - |
| | | | | | | |
| 20%(vol/vol) | + | + | + | - | - | - |
| 20%(vol/vol) | + | + | + | - | - | - |
| | | | | | | |
| 10%(vol/vol) | + | + | + | - | - | - |
| 0.1%(vol/vol) | + | + | + | - | - | - |
| 1%(vol/vol) | + | + | + | - | - | - |
| 10%(vol/vol) | + | + | + | - | - | - |
| 10%(vol/vol) | + | + | + | - | - | - |
| 10%(vol/vol) | + | + | + | - | - | - |
| | | | | | | |
| 10mg/mL | + | + | + | - | - | - |
| 5mg/mL | + | + | + | - | - | - |
| 5mg/mL | + | + | + | - | - | - |
| 5mg/mL | + | + | + | - | - | - |
| 5mg/mL | + | + | + | - | - | - |
| 1mg/mL | + | + | + | - | - | - |
| 20mg/mL | + | + | + | - | - | - |
| 10mg/mL | + | + | + | - | - | - |
| 5mg/mL | + | + | + | - | - | - |

4

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.

1. Comparison Studies
  Not applicable
1. 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.

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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