(155 days)
Not Found
No
The device description details a traditional immunoassay (line blot) with visual interpretation of bands, and there is no mention of AI/ML in the description, marketing points, or performance studies.
No.
This device is an in vitro diagnostic (IVD) test kit used for the qualitative detection of IgM antibodies to B. burgdorferi, which provides supportive evidence of infection. It does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the qualitative detection of IgM antibodies to B. burgdorferi sensu stricto (B31) in human serum" and "to provide supportive evidence of infection with B. burgdorferi." This directly aligns with the definition of a diagnostic device.
No
The device is a laboratory test kit that uses physical components (nitrocellulose strips, reagents, etc.) to detect antibodies in serum samples. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative detection of IgM antibodies to B. burgdorferi sensu stricto (B31) in human serum." This is a diagnostic test performed on a biological sample (human serum) outside of the body (in vitro).
- Device Description: The description details a laboratory assay involving the incubation of serum samples with antigens on a strip, followed by detection of bound antibodies using an enzyme conjugate and substrate. This is a typical process for an in vitro diagnostic test.
- Performance Studies: The document includes detailed performance studies (Reproducibility, Cross Reactivity, Interfering Substances, Specimen Collection and Handling Conditions, Sensitivity Testing, Analytical Specificity, CDC Reference Panel, Method Comparison) which are standard requirements for demonstrating the performance of an IVD.
- Key Metrics: The document provides key metrics like Sensitivity and Analytical Specificity, which are crucial for evaluating the diagnostic accuracy of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K951709; B. burgdorferi (IgM) Marblot Strip Test System) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit is intended for the qualitative detection of IgM antibodies to B. burgdorferi sensu stricto (B31) in human serum. This test is intended for use in testing human serum samples which have been found positive or equivocal using an ELISA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.
Product codes (comma separated list FDA assigned to the subject device)
LSR
Device Description
The assay requires a total of 70 minutes incubation time. The test uses purified antigens coated on nitrocellulose strips. Serum sample is added to each strip and incubated for 30 minutes. If Borrelia burgdorferi antibodies are present they will bind to the antigens on the strips. Unbound serum is removed by washing the wells three times. An enzyme-conjugated anti-human IgM is then added to each strip and incubated for 30 minutes. It will bind to the any antibody that was attached to the antigen on the strip. The wells are again washed three times followed by a DI water wash to remove any unbound conjugate. After unbound conjugate has been removed by a further washing step, a visualization of the antigenantibody-antibody complex is accomplished by the addition of a substrate which forms blue-violet precipitates at each site (antigen bands). The reaction is stopped by washing the nitrocellulose strip with distilled or deionized water. Depending on the observed band pattern one can interpret the presence or absence of specific IgM antibodies to B. burgdorferi infection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Tests:
Reproducibility: The reproducibility of the assay was done by testing a negative sample, a high negative sample, a low positive sample, and a moderate positive sample in triplicate for five days, twice a day, at three sites with two technicians per site giving a total of 90 data points per sample.
Band Reproducibility:
Negative: 0 significant bands
High Negative: ≤1 significant bands (41-0, 39-0, 23-79)
Low Positive: 2 significant bands (41-86, 39-0, 23-90)
Moderate Positive: 3 significant bands (41-90, 39-90, 23-90)
Sample Reproducibility:
Negative: Band Reproducibility 100% (0/0), Final Interpretation Negative 100% (90/90)
High Negative: Band Reproducibility 87.8% (79/90), Final Interpretation Negative 100% (90/90)
Low Positive: Band Reproducibility 97.8% (176/180), Final Interpretation Positive 95.6% (86/90)
Moderate Positive: Band Reproducibility 100% (270/270), Final Interpretation Positive 100% (90/90)
Cross Reactivity: A cross reactivity study was performed on 215 specimens known to contain potentially cross reactive antibodies to B. burgdorferi.
Tick-borne relapsing fever / Rickettsial Diseases (23 samples): 1 (4%) positive
Treponemal Infections (12 samples): 0 (0%) positive
Ehrlichiosis (20 samples): 1 (5%) positive
Babesiosis (20 samples): 2 (10%) positive
Leptospirosis (1 sample): 0 (0%) positive
Parvovirus B19 (9 samples): 0 (0%) positive
Epstein-Barr Virus (11 samples): 0 (0%) positive
Cytomegalovirus (32 samples): 0 (0%) positive
H. pylori (12 samples): 0 (0%) positive
Fibromyalgia (10 samples): 0 (0%) positive
Rheumatoid Arthritis (12 samples): 0 (0%) positive
Herpes Simplex Virus (16 samples): 0 (0%) positive
Varicella Zoster Virus (12 samples): 0 (0%) positive
Autoimmune Disease (25 samples): 0 (0%) positive
Interfering Substances: Evaluated high levels of hemoglobin (2 g/l), bilirubin (342 µmol/l), cholesterol (13 mmol/l), and intralipids (37 mmol/l) on six sera (two positive, one low positive, one high negative, and two negatives). No interference detected.
Specimen Collection and Handling Conditions: Samples gave consistent results after 2-8ºC for at least 168 hours, room temperature for up to 8 hours, and up to 10 freeze and thaw cycles.
Clinical Testing:
Sensitivity Testing: A sensitivity study was performed on 100 clinically characterized samples obtained from Allen C. Steere, MD at the Massachusetts General Hospital.
Early (40 samples): Line Blot Sensitivity 87.5% (35/40) [73.2%-95.8%], Commercially Available Device Sensitivity 77.5% (31/40) [61.6%-89.2%]
Disseminated (20 samples): Line Blot Sensitivity 95.0% (19/20) [75.1%-99.9%], Commercially Available Device Sensitivity 85% (17/20) [62.1%-96.8%]
Late (40 samples): Line Blot Sensitivity 27.5% (11/40) [14.6%-43.9%], Commercially Available Device Sensitivity 22.5% (9/40) [10.8%-38.5%]
Analytical Specificity (endemic & non-endemic): Testing of 234 asymptomatic samples from both endemic and non-endemic regions was performed.
Endemic (115 samples): 0 positive, Analytical Specificity 100%
Non-endemic (119 samples): 0 positive, Analytical Specificity 100%
CDC Reference Panel: A standard panel of positive and negative specimens provided by the Center of Disease Control (CDC) for Lyme disease detection was tested.
Healthy (5 samples): GSD Line Blot % Agreement 100% (5/5), Commercially Available Device % Agreement 100% (5/5)
Early (0-2 months) (15 samples): GSD Line Blot % Agreement 86.7% (13/15), Commercially Available Device % Agreement 73.3% (11/15)
Intermediate (3-12 months) (13 samples): GSD Line Blot % Agreement 92.3% (12/13), Commercially Available Device % Agreement 84.6% (11/13)
Late (>1year) (7 samples): GSD Line Blot % Agreement 57.1% (4/7), Commercially Available Device % Agreement 57.1% (4/7)
Method Comparison: The performance was determined by conducting a prospective clinical study at three different geographic sites (Pennsylvania, North Carolina, and California) in the U.S. Patient samples were tested by an anti-B. burgdorferi total antibody ELISA test first and the resulting equivocal and positive specimens were tested on the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot test and a commercially available B. burgdorferi IgM Blot test.
Positive Percent Agreement = 99.4% (154/155) [95% CI: 96.5-100%]
Negative Percent Agreement = 99.4% (154/155) [95% CI: 96.5-100%]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: Early 87.5%, Disseminated 95.0%, Late 27.5%
Analytical Specificity: 100%
Positive Percent Agreement = 99.4%
Negative Percent Agreement = 99.4%
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.
B. burgdorferi (IgM) Marblot Strip Test System (Distributed by Trinity Biotech) (K951709)
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
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
2012
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
| 1) Submitter's Name: | Gold Standard Diagnostics |
|---|---|
| Address: | 2851 Spafford St. Davis, CA. 95618 |
| Phone Number: | 530-759-8000 |
| Contact Person: | Napoleon Monce |
| Date: | May 27, 2012 |
-
- Product and Trade Name: Borrelia burgdorferi IgM B31 Line Blot Test Kit Common Name or Classification Name: Borrelia burgdorferi IgM Western blot
Product Code: LSR
- Product and Trade Name: Borrelia burgdorferi IgM B31 Line Blot Test Kit Common Name or Classification Name: Borrelia burgdorferi IgM Western blot
3) Legally marketed device to which the submitter claims equivalence B. burgdorferi (IgM) Marblot Strip Test System (Distributed by Trinity Biotech) (K951709).
4) Description of the device:
The assay requires a total of 70 minutes incubation time. The test uses purified antigens coated on nitrocellulose strips. Serum sample is added to each strip and incubated for 30 minutes. If Borrelia burgdorferi antibodies are present they will bind to the antigens on the strips. Unbound serum is removed by washing the wells three times. An enzyme-conjugated anti-human IgM is then added to each strip and incubated for 30 minutes. It will bind to the any antibody that was attached to the antigen on the strip. The wells are again washed three times followed by a DI water wash to remove any unbound conjugate. After unbound conjugate has been removed by a further washing step, a visualization of the antigenantibody-antibody complex is accomplished by the addition of a substrate which forms blue-violet precipitates at each site (antigen bands). The reaction is stopped by washing the nitrocellulose strip with distilled or deionized water. Depending on the observed band pattern one can interpret the presence or absence of specific IgM antibodies to B. burgdorferi infection.
5) Intended use of the device
The Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit is intended for the qualitative detection of IgM antibodies to B. burgdorferi sensu stricto (B31) in human serum. This test is intended for use in testing human serum samples which have been found positive or equivocal using an ELISA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.
6) Comparison with the predicate device
The Gold Standard Diagnostics Borrelia Burgdorferi B31 IgM Line Blot Test Kit was compared to a commercially marketed kit by Trinity Biotech the B. burgdorferi (IgM) Marblot Strip Test System
2.1
1
(K951709). Both kits have the same intended use and use the same methodology. Below are tables comparing the reagents and the procedures of the two devices.
| Gold Standard Diagnostics B. burgdorferi
B31 IgM Line Blot Test Kit | Trinity Biotech B. burgdorferi (IgM)
Marblot Strip Test |
|------------------------------------------------------------------------|------------------------------------------------------------|
| Antigen coated nitrocellulose strips | Antigen coated nitrocellulose strips |
| IgM Conjugate - 100x | IgM Conjugate - 10x |
| Substrate – BCIP/NBT | Substrate |
| IgM Positive Control | IgM Band Locator Control |
| IgM Cutoff Control | IgM Weak Reactive Control |
| IgM Negative Control | IgM Negative Control . |
| Diluent/Wash Concentrate - 10x | Diluent/Wash Concentrate - 10x |
Table 1: Reagent Comparison
Table 2: Procedure Comparison
| Gold Standard Diagnostics B. burgdorferi
B31 IgM Line Blot Test Kit | Trinity Biotech B. burgdorferi (IgM)
Marblot Strip Test |
|-------------------------------------------------------------------------------|------------------------------------------------------------|
| Dilute Samples 1:101 in Diluent/Wash | Dilute Samples 1:101 in Diluent/Wash |
| Add 15ul of Samples | Add 20ul of Samples |
| Incubate for 30 minutes while rocking | Incubate for 30 minutes while rocking |
| Wash three times with reconstituted | Wash three times with reconstituted |
| Diluent/Wash Solution | Diluent/Wash Solution |
| Add 1.5ml of reconstituted Conjugate | Add 2ml of reconstituted Conjugate |
| Incubate for 30 minutes while rocking | Incubate for 15 minutes while rocking |
| Wash three times with reconstituted | Wash three times with reconstituted |
| Diluent/Wash Solution | Diluent/Wash Solution |
| Wash one time with DI water | Wash one time with DI water |
| Add 1.5ml of Substrate | Add 2ml of Substrate |
| Incubate for 10 minutes ± 3 minutes while rocking | Incubate for 4-12 minutes while rocking |
| Wash three times with 1.5ml DI water | Wash three times with 2.0ml DI water |
6(b1) Nonclinical Tests:
. Reproducibility
The reproducibility of the assay was done by testing a negative sample, a high negative sample, a low positive sample, and a moderate positive sample in triplicate for five days, twice a day, at three sites with two technicians per site giving a total of 90 data points per sample. Results of band reproducibility and sample reproducibility are shown below:
2
Band Reproducibility
| Sample/kDa | 41 | 39 | 23 | Number
of Bands |
|----------------------|----|----|----|----------------------------|
| Negative | 0 | 0 | 0 | 0
significant
bands |
| High
Negative | 0 | 0 | 79 | ≤1
significant
bands |
| Low
Positive | 86 | 0 | 90 | 2
significant
bands |
| Moderate
Positive | 90 | 90 | 90 | 3
significant
bands |
Sample Reproducibility
| Final Interpretation | |||
|---|---|---|---|
| Band Reproducibility | Positive | Negative | |
| Sample | |||
| Negative | 100% (0/0) | 100% (90/90) | |
| High Negative | 87.8% (79/90) | 100% (90/90) | |
| Low Positive* | 97.8% (176/180) | 95.6% (86/90) | |
| Moderate Positive | 100% (270/270) | 100% (90/90) |
- A low positive sample is expected to yield a positivity of 95%.
Cross Reactivity
A cross reactivity study was performed on 215 specimens known to contain potentially cross reactive antibodies to B. burgdorferi. Sera from patients with infections and sera from patients with diagnoses that can be confused with the late manifestations of Lyme disease were tested. The results are summarized in the following table:
| Infection / Diagnosis | Number of sera tested | # Positive / (%) |
|---|---|---|
| Tick-borne relapsing fever / | ||
| Rickettsial Diseases | 23 | 1 / (4%) |
| Treponemal Infections | 12 | 0 / (0%) |
| Ehrlichiosis | 20 | 1 / (5%) |
| Babesiosis | 20 | 2 / (10%) |
| Leptospirosis | 1 | 0 / (0%) |
2.3
3
| Parvovirus B19 | 9 | 0 / (0%) |
|---|---|---|
| Epstein-Barr Virus | 11 | 0 / (0%) |
| Cytomegalovirus | 32 | 0 / (0%) |
| H. pylori | 12 | 0 / (0%) |
| Fibromyalgia | 10 | 0 / (0%) |
| Rheumatoid Arthritis | 12 | 0 / (0%) |
| Herpes Simplex Virus | 16 | 0 / (0%) |
| Varicella Zoster Virus | 12 | 0 / (0%) |
| Autoimmune Disease | 25 | 0 / (0%) |
Two of the 20 Babesiosis samples and one each of the 23 Tick-borne relapsing fever / Rickettsial Disease and 20 Ehrlichiosis specimens were positive on the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot Test. These samples were also tested on the predicate device which also gave positive results.
Interfering Substances
The effect of potential interfering substances on samples using the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot Test was evaluated. High levels of hemoglobin, bilirubin, cholesterol and intralipids in serum samples were tested on six sera (two positive, one low positive, one high negative, and two negatives). The recommended concentrations from the guideline "Interference Testing in Clinical Chemistry" from the Clinical and Laboratory Standards Institute were used. The interferents at the concentrations tested did not have any influence on the band pattern. A small variability in band intensity was seen that is in the normal range of deviation and did not change the final interpretation. The results are summarized in the following table:
| Substance | Concentration | Interference |
|---|---|---|
| Hemoglobin | 2 g/l | None detected |
| Bilirubin | 342 µmol/l | None detected |
| Cholesterol | 13 mmol/l | None detected |
| Intralipids | 37 mmol/l | None detected |
Specimen Collection and Handling Conditions
A study was performed to substantiate the specimen storage and handling conditions for the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot Test. Three samples were tested in triplicate after the following storage conditions:
- A) 2-8ºC for 24, 48, 72, 96, 120, 144 and 168 hours.
- B) Room temperature for 2, 6 and 8 hours.
- C) After 1, 5 and 10 freeze and thaw cycles.
4
The samples gave consistent results for all testing parameters above, therefore the specimens can be held at 2-8°C for at least 168 hours or at room temperature for up to 8 hours and withstand up to 10 freeze and thaw cycles.
8) Clinical Testing
Sensitivity Testing
A sensitivity study was performed on 100 clinically characterized samples obtained from Allen C. Steere, MD at the Massachusetts General Hospital. The samples encompassed early, disseminated, and late stages of Lyme disease. The results are summarized in the following table:
| | Number of
Samples | Line Blot Sensitivity
with 95% CI | Commercially Available
Device Sensitivity with
95% CI |
|--------------|----------------------|--------------------------------------|-------------------------------------------------------------|
| Early | 40 | 87.5% (35/40)
[73.2%-95.8%] | 77.5% (31/40)
[61.6%-89.2%] |
| Disseminated | 20 | 95.0% (19/20)
[75.1%-99.9%] | 85% (17/20)
[62.1%-96.8%] |
| Late | 40 | 27.5% (11/40)
[14.6%-43.9%] | 22.5% (9/40)
[10.8%-38.5%] |
Analytical Specificity (endemic & non-endemic)
For the determination of analytical specificity, testing of 234 asymptomatic samples from both endemic and non-endemic regions was performed. The results are summarized in the following table:
| Region | Number of Samples | Number Positive | Analytical Specificity |
|---|---|---|---|
| Endemic | 115 | 0 | 100% |
| Non-endemic | 119 | 0 | 100% |
CDC Reference Panel
A standard panel of positive and negative specimens provided by the Center of Disease Control (CDC) for Lyme disease detection was tested both on the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot Test and on the predicate device. The results are summarized in the following table:
5
| Stage | Total | GSD Line Blot
% Agreement | Commercially
Available Device
% Agreement |
|-------------------------------|-------|------------------------------|-------------------------------------------------|
| Healthy | 5 | 100% (5/5) | 100% (5/5) |
| Early
(0-2 months) | 15 | 86.7% (13/15) | 73.3% (11/15) |
| Intermediate
(3-12 months) | 13 | 92.3% (12/13) | 84.6% (11/13) |
| Late
(>1year) | 7 | 57.1% (4/7) | 57.1% (4/7) |
Method Comparison
The performance of the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot test was determined by conducting a prospective clinical study at three different geographic sites (Pennsylvania, North Carolina, and California) in the U.S. The patient samples were tested by an anti-B. burgdorferi total antibody ELISA test first and the resulting equivocal and positive specimens were tested on the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot test and a commercially available B. burgdorferi IgM Blot test. The results are summarized in the following table:
| Trinity Biotech IgM Blot | |||
|---|---|---|---|
| Positive | Negative | ||
| Gold Standard Diagnostics | Positive | ||
| IgM Line Blot | Negative |
Positive Percent Agreement = 99.4% (154/155) [95% CI: 96.5-100%] Negative Percent Agreement = 99.4% (154/155) [95% CI: 96.5-100%]
The discrepant samples were tested on a second commercially available assay. On the one Line Blot negative sample that was positive by the predicate, the second assay gave a positive result. Of the one Line Blot positive and predicate negative samples, the second assay called the sample positive.
The 310 samples were also tested by the Gold Standard B. burgdorferi IgG Line Blot test and 36.8% ( 14/310) were found to be positive and 63.2% (196/310) were found to be negative.
9) Conclusion
From the performance data and kit comparison above, it is our conclusion that the Gold Standard Diagnostics B. burgdorferi B31 IgM Line Blot Test Kit is substantially equivalent to the B. burgdorferi (IgM) Marblot Strip Test System (K951709) commercially marketed by Trinity Biotech.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Gold Standard Diagnostics C/O Napoleon Monce Director, Product Development 2851 Spafford St. Davis, CA. 95618
JUN - 1 2012
Re: K113846
Trade/Device Name: Borrelia burgdorferi B31 IgM Line Blot Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: December 28, 2011 Received: March 8, 2012
Dear Mr. Monce:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
7
Page 2 - Napoleon Monce
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 Diagnostic Device Evaluation and Safety 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 Schref for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K113846
Device Name: Borrelia burgdorferi B31 IgM Line Blot Test Kit
Indications For Use:
The Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit is intended for the qualitative detection of IgM antibodies to B. burgdorferi sensu stricto (B31) in human serum. This test is intended for use in testing human serum samples which have been found positive or equivocal using an ELISA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Tuare Felmberg
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(K) 1/2 11 38 4 6
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