(154 days)
Not Found
No
The description details a lateral flow immunoassay read by a system reader, which is a standard method for rapid antigen detection. There is no mention of AI, ML, or image processing that would suggest the use of such technologies for interpretation or analysis. The performance studies and metrics are typical for a diagnostic test and do not indicate AI/ML involvement.
No
This device is a diagnostic tool used to detect Group A Streptococcus antigen. It aids in diagnosis but does not directly treat or prevent a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used... as an aid in the diagnosis of Group A Strep."
No
The device description clearly states it is a "qualitative, lateral flow immunoassay" and uses an "Assay device" and a "BD Veritor™ System Reader," indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it's for the "direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients." This is a diagnostic test performed on a biological sample (throat swab) outside of the body (in vitro).
- Device Description: It describes a "qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab." Immunoassays performed on biological samples are a common type of IVD.
- Clinical Studies: The document details clinical studies evaluating the performance of the device using patient specimens, which is a requirement for IVD devices.
- Key Metrics: Sensitivity and Specificity are provided, which are standard performance metrics for diagnostic tests.
- Predicate Device: A predicate device (Clearview Advanced™ Strep A Test) is mentioned, which is common in regulatory submissions for IVDs.
All of these characteristics align with the definition and typical features of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Veritor" System for Rapid Detection of Group A Strep test is a rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients. It is intended to be used in conjunction with the BD Veritor™ System Reader as an aid in the diagnosis of Group A Strep. 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 BD Veritor System for rapid detection of Group A Strep test is intended for use in point-of-care or laboratory settings.
Product codes (comma separated list FDA assigned to the subject device)
GTY
Device Description
The BD Veritor™ System for rapid detection of Group A Strep is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the Assay device. During testing, the processed throat swab specimen reacts with an antibody to Strep A that is conjugated onto detector particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and is captured by the line of antibody on the membrane. A positive result for Strep A is determined by the BD Veritor ™ System Reader when antigen-conjugate is deposited at the Test "T" position and the Control "C" position on the BD Veritor™ System Strep A assay device.
Mentions image processing
An opto-electronic reader determines the line intensity at each of the spatially-defined test and control line positions, interprets the results using the scoring algorithm, and reports a positive, negative, or invalid result on the LCD screen based on pre-set thresholds.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Throat swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care or laboratory settings.
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)
Clinical Studies:
Performance characteristics for the BD Veritor™ System for Rapid Detection of Group A Strep were established in a multi-center clinical trial conducted at one clinical laboratory site and four POC sites during the 2011-2012 respiratory season. A total of 796 prospectively collected specimens were evaluated using the BD Veritor™ System for Rapid Detection of Group A Strep and bacterial culture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 96.6% (92.3%, 98.6%)
Specificity: 95.5% (93.6%, 96.9%)
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.
Clearview Advanced™ Strep A Test K091489
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.
0
BD Veritor The System for Rapid Detection of Group A Strep
K1227/8
510(k) SUMMARY
FEB 0 6 2013
BECTON, DICKINSON AND COMPANY SUBMITTED BY: 10865 Road to the Cure, Suite 200 San Diego, CA 92121 Phone: 858-795-7890 Fax: 858-812-8505 Gregory Payne
CONTACT NAME: DATE PREPARED: January 31, 2013
DEVICE TRADE NAME: BD Veritor™ System for Rapid Detection of Group A Strep
DEVICE COMMON NAME: Streptococcus spp. serological reagents
21 CFR § 866.3740 DEVICE CLASSIFICATION:
PREDICATE DEVICES: Clearview Advanced™ Strep A Test
INTENDED USE:
The BD Veritor" System for Rapid Detection of Group A Strep test is a rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients. It is intended to be used in conjunction with the BD Veritor™ System Reader as an aid in the diagnosis of Group A Strep. 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 BD Veritor System for rapid detection of Group A Strep test is intended for use in point-of-care or laboratory settings.
DEVICE DESCRIPTION:
The BD Veritor™ System for rapid detection of Group A Strep is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the Assay device. During testing, the processed throat swab specimen reacts with an antibody to Strep A that is conjugated onto detector particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and is captured by the line of antibody on the membrane. A positive result for Strep A is determined by the BD Veritor ™ System Reader when antigen-conjugate is deposited at the Test "T" position and the Control "C" position on the BD Veritor™ System Strep A assay device.
BD Diagnostic Systems Becton, Dickinson and Company
1
DEVICE COMPARISON:
The BD Veritor™ System for Rapid Detection of Group A Strep was compared to the Clearview Advanced™ Strep A test K091489.
| Product Feature | BD Veritor™ System for Rapid Detection of Group A Strep | Binax Clearview Advanced Strep A test K091489 |
|---|---|---|
| Intended Use | The BD Veritor™ System for Rapid Detection of Group A Strep test is a rapid chromatographic immunoassay for the direct and qualitative detection of group A Streptococcus antigen from throat swab specimens of symptomatic patients to aid in diagnosis of Group A Streptococcus infection. It is intended to be used in conjunction with the BD Veritor™ System Reader as an aid in the diagnosis of Group A Streptococcal infection. | The Binax Clearview Advanced™ Strep A test is a rapid chromatographic immunoassay for the qualitative detection of group A Streptococcus antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection. |
| Specimen Types | Throat swabs | Throat swabs |
| Assay Technology | Immunochromatographic | Immunochromatographic |
| Detection Format | An opto-electronic reader determines the line intensity at each of the spatially-defined test and control line positions, interprets the results using the scoring algorithm, and reports a positive, negative, or invalid result on the LCD screen based on pre-set thresholds. | Visual determination of presence or absence of pink-to-red Test Line and the appearance of a blue Procedural Control Line on the test strip indicate the presence of Group A Streptococcal antigen. |
| Qualitative or Quantitative | Qualitative | Qualitative |
| Product | ||
| Feature | BD Veritor™ System for | |
| Rapid Detection of Group A | ||
| Strep | Binax Clearview | |
| Advanced Strep A | ||
| test K091489 | ||
| Total Assay Time | Approximately 5 minutes | Less than 5 minutes |
| Control format | • Kit Strep A positive control swab | |
| • Kit Strep A negative control swab | ||
| • Internal control lines | • Kit Strep A positive control swab | |
| • Kit Strep A negative control swab | ||
| Detection of | ||
| Group A Strep | Test will indicate the | |
| presence of both viable and | ||
| non-viable group A | ||
| Streptococcus bacteria | Test will indicate the | |
| presence of both | ||
| viable and non-viable | ||
| group A | ||
| Streptococcus | ||
| bacteria |
· ·
2
SUMMARY OF PERFORMANCE DATA:
Analytical Sensitivity
The limit of detection for Streptococcus pyogenes was established with the BD Veritor" System for Rapid Detection of Group A Strep test. The limit of detection (LOD) is defined as the lowest concentration that produces an approximate 95% positive reaction when tested with 60 replicates.
| STRAIN | LOD
(CFU/mL) | Results | %
Positivity |
|--------|-----------------|-------------------|-----------------|
| 12384 | $1 \times 10^5$ | 57/60
Positive | 95.0% |
| 19615 | $5 \times 10^4$ | 58/60
Positive | 96.7% |
| 25663 | $2 \times 10^5$ | 57/60
Positive | 95.0% |
Analytical Specificity
The reactivity of various Streptococcal strains was determined with the BD Veritor" System for Rapid Detection of Group A Strep test. Lancefield Groups A, B, C, D, F and G were tested at 1X109 CFU/mL in triplicate and yielded negative results.
3
Various microorganisms (including bacteria and yeasts) that might be found in specimens
were evaluated for potential cross reactivity with the BD Veritor " System for Rapid Detection of Group A Strep test.
| Microorganism Name | Concentration
Tested | Group A Strep. Test
Result |
|---------------------------------------------------------------------------|-------------------------|-------------------------------|
| Arcanobacterium haemolyticum | 1x109 CFU/mL | Negative |
| Bordetella pertussis | 5x108 CFU/mL | Negative |
| Candida albicans | 1x109 CFU/mL | Negative |
| Corynebacterium diphtherium sp
(Corynebacterium sp) | 1x109 CFU/mL | Negative |
| Enterococcus faecalis | 1x109 CFU/mL | Negative |
| Enterococcus faecium | 1x109 CFU/mL | Negative |
| Escherichia coli | 1.5x109 CFU/mL | Negative |
| Fusobacterium necrophorum | 1x109 CFU/mL | Negative |
| Haemophilus influenzae | 1x109 CFU/mL | Negative |
| Haemophilus parahemolyticus | 1.2x105 CFU/mL | Negative |
| Haemophilus parainfluenzae | 1x109 CFU/mL | Negative |
| Klebsiella pneumoniae | 1.5x109 CFU/mL | Negative |
| Lactobacillus sp (Lactobacillus
casei) | 1x109 CFU/mL | Negative |
| Moraxella catarrhalis | 1x109 CFU/mL | Negative |
| Moraxella lacunata | 1x109 CFU/mL | Negative |
| Mycobacterium tuberculosis
avirulent | 5x106 CFU/mL | Negative |
| Neisseria gonorrhoeae | 1x109 CFU/mL | Negative |
| Neisseria lactamica | 1x109 CFU/mL | Negative |
| Neisseria meningitidis | 1x109 CFU/mL | Negative |
| Neisseria mucosa | 1x106 CFU/mL | Negative |
| Neisseria sicca | 1x109 CFU/mL | Negative |
| Neisseria subflava | 1x109 CFU/mL | Negative |
| Proteus vulgaris | 1x109 CFU/mL | Negative |
| Pseudomonas aeruginosa | 1x109 CFU/mL | Negative |
| Serratia marcescens | 1x109 CFU/mL | Negative |
| Staphylococcus aureus | 1x109 CFU/mL | Negative |
| Staphylococcus epidermidis | 1x109 CFU/mL | Negative |
| Staphylococcus haemolyticus | 1x109 CFU/mL | Negative |
| Streptococcus anginosus | 1x109 CFU/mL | Negative |
| Streptococcus mitis | 1x109 CFU/mL | Negative |
| Streptococcus
mutans
ATCC25173 | 3x109 CFU/mL | Negative |
| Staphylococcus oralis | 1x109 CFU/mL | Negative |
| Streptococcus pneumoniae | 1x109 CFU/mL | Negative |
| BD VeritorTM System for Rapid Detection of Group A Strep Cross Reactivity | | |
| Study Results - Bacteria and Yeast | | |
| Microorganism Name | Concentration
Tested | Group A Strep Test
Result |
| Staphylococcus sanguis | 1x109 CFU/mL | Negative |
| Streptococcus sp. Group B | 1x109 CFU/mL | Negative |
| Streptococcus sp. Group C | 1x109 CFU/mL | Negative |
| Streptococcus sp. (bovis II)
Group D | 1x109 CFU/mL | Negative |
| Streptococcus sp. Group F | 1x109 CFU/mL | Negative |
| Streptococcus sp. Group G | 1x109 CFU/mL | Negative |
| Yersinia enterocolitica | 1x109 CFU/mL | Negative |
| Adenovirus Type 1 | 1.6x106 TCID50 /mL | Negative |
| Adenovirus Type 7 | 2.81x105
TCID50/mL | Negative |
| Cytomegalovirus | 8.9x103 TCID50/mL | Negative |
| Enterovirus (VR-28 Human
Coxsackievirus) | 8.9x106TCID50/mL | Negative |
| Epstein Barr Virus | N/A | Negative |
| HSV Type 1 (HF) | 8.89x106
TCID50/mL | Negative |
| Human coronavirus OC43 | 2.81x104
TCID50/mL | Negative |
| Human metapneumovirus
(HMPV-27 A2) | 2.8x106 TCID50/mL | Negative |
| Human parainfluenza | 2.8x106 TCID50/mL | Negative |
| Measles | 1.6x104 TCID50/mL | Negative |
| Mumps virus | 1.6x105 TCID50/mL | Negative |
| Respiratory syncytial virus VR-
26 | 1.6 x 107
TCID50/mL | Negative |
| Rhinovirus | 2.8x106 TCID50/mL | Negative |
Streptococcus salivarius
Negative
1x109 CFU/mL
4
Of the microorganisms tested, none demonstrated cross-reactivity with the BD Veritor™ System for Rapid Detection of Group A Strep test.
Interfering Substances
Various substances were evaluated for potential interference with the BD Veritor™ System for Rapid Detection of Group A Strep test at concentrations comparable to or greater than levels that may be present in patient respiratory samples.
| Substance | Concentration
Tested | Interference
with Group
A Result |
|------------------------------------------|-------------------------|----------------------------------------|
| 4-Acetamidophenol | 10 mg/mL | No |
| Acetylsalicylic acid | 20 mg/mL | No |
| Albuterol | 0.083 mg/mL | No |
| Amantadine | 500 ng/mL | No |
| Ascorbic acid chewable tablets | 5% by weight | No |
| Beclomethasone | 500 ng/mL | No |
| Benzocaine throat spray
(Cepacol) | 5% by volume | No |
| Blood, type A | 2% (v/v) | No |
| Blood, type B | 2% (v/v) | No |
| Blood, type AB | 2% (v/v) | No |
| Blood, type O | 2% (v/v) | No |
| Budesonide | 500 ng/mL | No |
| Chlorpheniramine maleate | 5 mg/mL | No |
| Dexamethasone | 10 mg/mL | No |
| Dextromethorphan (10 mg/mL) | 10 mg/mL | No |
| Dyclonine HCI lozenges
(Sucrets) | 5% w/v | No |
| Diphenhydramine HCI | 5 mg/mL | No |
| Fexofenadine | 500 ng/mL | No |
| FluMist | 1% v/v | No |
| Fluticasone | 500 ng/mL | No |
| Guaiacol Glyceryl Ether | 20 mg/mL | No |
| Ibuprofen | 10 mg/mL | No |
| Loratidine | 100 ng/mL | No |
| Menthol Throat Lozenges | 5% w/v | No |
| Mometasone | 500 ng/mL | No |
| Mouthwash (at 5% by volume)
Listerine | 5% (v/v) | No |
| Mouthwash Scope | 5% v/v | No |
| Mouthwash CVS | 5% v/v | No |
| Mucin, salivary protein, purified | 1 mg/mL | No |
| Nasal Spray | 5% v/v | No |
| Nasal Spray | 5% v/v | No |
| Nasal Spray | 5% v/v | No |
| Oseltamivir | 500 ng/mL | No |
| Oxymetazoline | 0.05 mg/mL | No |
| Phenol throat spray
(Chloraseptic) | 5% v/v | No |
| Phenylephrine | 1 mg/mL | No |
| Pseudoephedrine HCI | 20 mg/mL | No |
| Throat drops: CVS | 5% w/v | No |
| Throat drops: Pedia Care | 5% w/v | No |
| Throat drops: Triaminic | 5% w/v | No |
| Tobramycin | 500 ng/mL | No |
| Triamcinolone | 500 ng/mL | No |
| Zanamivir | 1 mg/mL | No |
| Zicam throat spray (Zn / | 5% v/v | No |
| benzalkonium chloride) | | |
| Zinc Lozenges | 5% w/v | No |
BD Diagnostic Systems Becton, Dickinson and Company ... . . . . . . .
5
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:
6
BD Veritor TM System for Rapid Detection of Group A Strep
Of the substances tested in this study, none exhibited interference when either Group A positive or Group A negative samples were tested with the BD Veritor™ System for Rapid Detection of Group A Strep test.
Media Compatibility
Various types of transport media and culture plate media commonly used in Strep A testing were evaluated for compatibility with the BD Veritor™ System for Rapid Detection of Group A Strep test. The effects of frozen storage of transport media samples on the stability of the antigen were evaluated in this study. The media tested were: Modified Amies, Modified Stuart's, Normal Saline and Phosphate Buffered Saline. The agar tested were Tryptic Sov Agar with 5% Sheep Blood and Selective Strep Agar.
Of the four media tested in this evaluation, all four demonstrated the expected results and met the acceptance criteria for both room temperature and overnight frozen storage conditions. Therefore, these four media are all compatible with the BD Group A Strep test. Although the media were non-interfering, dry swab transport and storage is recommended for testing with the BD Group A Strep test. Storage and transport of Strep A specimens in liquid transport will likely dilute the antigen while streaking on solid culture media may remove some organism from the swab, thus resulting in a lower number of bacteria introduced into the extraction reagent.
No interference was seen with the agar tested.
CLINICAL STUDIES
Performance characteristics for the BD Veritor™ System for Rapid Detection of Group A Strep were established in a multi-center clinical trial conducted at one clinical laboratory site and four POC sites during the 2011-2012 respiratory season. A total of 796 prospectively collected specimens were evaluated using the BD Veritor™ System for Rapid Detection of Group A Strep and bacterial culture. Throat swabs from symptomatic patient were obtained, 51.8% from females and 48.2% were from males. Specimens from patients five years old or younger comprised 39.1% of the total, with 59.3% from patients 6 to 21 years of age and 1,6% from patients 22 years of age or older.
7
The performance of the BD Veritor™ System for Rapid Detection of Group A Strep was determined by comparison to bacterial culture and is presented in the table below.
| Clinical Performance Data | |||
|---|---|---|---|
| Culture | |||
| Veritor | P | N | |
| P | 144 | 29 | 173 |
| N | 5 | 618 | 623 |
| 149 | 647 | 796 |
Specificity: 95.5% (93.6%, 96.9%)
| Culture-Reference | ||||
|---|---|---|---|---|
| Site | ||||
| Code | Veritor | P | N | Total |
| Clinical | ||||
| Site | P | 20 | 2 | 22 |
| N | 0 | 82 | 82 | |
| Total | 20 | 84 | 104 | |
| Reference Method: Culture-Reference | ||||
| Sensitivity: 100% (83.9%, 100%) | ||||
| Specificity: 97.6% (91.7%, 99.3%) | ||||
| POC 1 | P | 54 | 3 | 57 |
| N | 5 | 188 | 193 | |
| Total | 59 | 191 | 250 | |
| Reference Method: Culture-Reference | ||||
| Sensitivity: 91.5% (81.6%, 96.3%) | ||||
| Specificity: 98.4% (95.5%, 99.5%) | ||||
| POC 2 | P | 21 | 9 | 30 |
| N | 0 | 111 | 111 |
BD Diagnostic Systems Becton, Dickinson and Company
8
| Clinical Performance Data - By Site | ||||
|---|---|---|---|---|
| Site | ||||
| Code | Veritor | Culture-Reference | ||
| P | N | Total | ||
| POC 3 | P | 21 | 7 | 28 |
| POC 3 | N | 0 | 106 | 106 |
| Total | 21 | 113 | 134 | |
| Reference Method: Culture-Reference | ||||
| Sensitivity: 100% (84.5%, 100%) | ||||
| Specificity: 93.8% (87.8%, 97.0%) | ||||
| POC 4 | P | 28 | 8 | 36 |
| POC 4 | N | 0 | 131 | 131 |
| Total | 28 | 139 | 167 | |
| Reference Method: Culture-Reference | ||||
| Sensitivity: 100% (87.9%, 100%) | ||||
| Specificity: 94.2% (89.1%, 97.1%) |
Reproducibility
The reproducibility of the BD Veritor™ System for Rapid Detection of Group A Strep was evaluated at one clinical and two POC sites. The panel was composed of 4 simulated Group A Strep samples. These included high negative samples ( i.e. samples containing a very low concentration of Group A Strep), a low positive sample (near the limit of detection), a moderate positive sample and a negative sample. The panel was tested by two operators at each site over five days. The results are summarized below.
| BD Veritor™ Group A Strep Reproducibility | ||||
|---|---|---|---|---|
| Sample | Site 1 | Site 2 | Site 3 | Total |
| High negative | 3.3% (1/30) | 0% (0/30) | 0% (0/30) | 1.1% (1/90) |
| (0.6%, 16.7%) | (0%, 11.3%) | (0%, 11.3%) | (0.2%, 6%) | |
| Low positive | 96.7% (29/30) | 83.3% (25/30) | 93.3% (28/30) | 91.1% (82/90) |
| (83.3%, 99.4%) | (66.4%, 92.7%) | (78.7%, 98.2%) | (83.4%, 95.4%) | |
| Moderate positive | 100% (30/30) | 96.7% (29/30) | 100% (30/30) | 98.9% (89/90) |
| (88.6%, 100%) | (83.3%, 99.4%) | (88.6%, 100%) | (94%, 99.8%) |
9
BD Veritor™ System for Rapid Detection of Group A Strep
| Negative
. | 0% (0/30) | 0% (0/30) | 0% (0/30) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
0% (0/90) |
|---------------|---------------------|----------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1 3%
10%.
l.J | 10%.
11.3%) | 11.3%)
(0%. | (0%, 4.1%) |
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Image /page/10/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is horizontally oriented and centered. To the left of the text is a stylized graphic, possibly a logo, with a series of vertical lines.
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.
February 6, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Becton, Dickinson and Company C/O Gregory Payne Director, Quality Systems and Regulatory Affairs 10865 Road to the Cure, Suite 200 San Diego, CA 92121
Re: K122718
Trade/Device Name: BD Veritor™ System for Rapid Detection of Group A Strep · Regulation Number: 21 CFR 866. 3740 Regulation Name: Streptococcus spp. Serological Reagents Regulatory Class: Class I Product Code: GTY Dated: January 17, 2013 Received: January 23, 2013
Dear Mr. Payne:
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.
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
11
Page 2 - Gregory Payne
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely yours.
Uwe Scherf for
Sally A. Hoivat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
12
BD Veritor" System for Rapid Detection of Group A Strep CONFIDENTIAL AND PROPRIETARY Clinical Laboratory Product
510(k) Number: K122718
Device Name: BD Veritor ™ System for Rapid Detection of Group A Strep
Indications for Use:
The BD Veritor" System for Rapid Detection of Group A Strep test is a rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients. It is intended to be used in conjunction with the BD Veritor"" System Reader as an aid in the diagnosis of Group A Strep. 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 BD Veritor System for rapid detection of Group A Strep test is intended for use in point-of-care or laboratory settings.
Over-the-Counter Use AND/OR Prescription Use V (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
csk Raquel Peat, PhD
Division Sidn-
Office of In Vitro Diagnostics and Radiological Health
K122 718 510(k)