(308 days)
Not Found
No
The device description details a standard ELISA assay which relies on biochemical reactions and spectrophotometric measurement, not AI/ML. There is no mention of AI/ML in the document, and the performance studies describe traditional analytical and clinical comparisons.
No
This device is an in vitro diagnostic test kit intended for the qualitative detection of IgA antibodies to H. pylori in human serum. It is used to aid in diagnosis, not to provide therapy or treatment.
Yes
This device is intended for the qualitative detection of IgA antibodies to H. pylori in human serum to aid in the diagnosis of H. pylori, which clearly indicates a diagnostic purpose.
No
The device description clearly outlines a laboratory-based ELISA test kit involving physical reagents, incubation steps, washing, and spectrophotometric measurement, indicating it is a hardware-based diagnostic assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of IgA antibodies to H. pylori in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a medical condition (H. pylori infection).
- Device Description: The description details a laboratory-based assay using reagents and a spectrophotometer to analyze the serum sample. This is characteristic of an in vitro diagnostic test.
- Anatomical Site: The sample is "human serum," which is a biological specimen taken from a patient.
- Performance Studies: The performance studies involve testing human serum samples and comparing the results to other commercially available ELISA assays, which are also IVDs.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Helicobacter pylori (H. pylori) ELISA IgA test kit is intended for the qualitative detection of IgA antibodies to H. pylori in human serum in the adult population. This test is intended as a second test to aid in the diagnosis of H. pylori in patients with gastrointestinal symptoms, in conjunction with clinical findings. It should be performed and interpreted with another assay for detection of IgG antibodies to H. pylori.
Product codes (comma separated list FDA assigned to the subject device)
LYR
Device Description
The assay requires a total of 90 minutes incubation time. The test uses purified antigen coated on microtiter wells. Serum is added to each well and incubated for 30 minutes at 37°C. If H. pylori IgA antibodies are present they will bind to the antigen in the well. Unbound serum is removed by washing the wells three times. An HRP-conjugated anti-human IgA is then added to each well and incubated for 30 minutes at 37°C. If H. pylori antibody is present, it will bind to the antibody attached to the antigen on the wells are again washed three times to remove any unbound conjugate. A TMB substrate is added to each well and incubated for 30 minutes at 37°C. If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, Stop Solution and the color intensity is measured the reaction is stopped with a spectrophotometrically.
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
adult population
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
The performance of the Gold Standard Diagnostics H. pylori ELISA IgA assay was determined by conducting a correlation study using 625 samples being routinely tested for H. pylori. The samples were tested on both the Gold Standard Diagnostics H. pylori ELISA IgA assay and a commercially available ELISA assay (Micro Detect Inc. K003794) as the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
Intra and inter assay precision was calculated using six patient sera (four positives and two negatives) at three different sites.
Reproducibility was performed by testing three samples (high negative, low positive, moderate positive) in triplicate for five days, twice a day, at three sites with two technicians per site.
Cross Reactivity: An adsorption study evaluated cross reactivity with H. pylori, Candida albicans, E. coli, Borrelia burgdorferi, Clostridium spp., Campylobacter, Bacillus, Enterobacter, Pseudomonas, Haemophilus Influenza, and Proteus. Mean percent inhibition for H. pylori was 96%, and 0.8% to 10.9% with other organisms, indicating no significant analytical specificity effects.
Interfering Substance: Evaluated the effect of high levels of hemoglobin, bilirubin, cholesterol, and triglycerides on samples at the assay cutoff (9-11 units) in triplicate. No interference was noted.
Clinical Comparison:
A correlation study of 625 samples comparing the Gold Standard Diagnostics H. pylori ELISA IgA assay to Micro Detect Inc. K003794. Discrepant samples were further tested on Inova QUANTA Lite™ H. pylori IgA ELISA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Nonclinical tests:
Intra-Assay CV: Site 1: 2.5% - 7.1%, Site 2: 4.8% - 7.9%, Site 3: 5.3% - 12.2%
Inter-Assay CV: 6.4% - 13.7%
Reproducibility: CV varied by site and technician, ranging from 4.1% to 18.0%.
Cross Reactivity: Mean percent inhibition for H. pylori was 96%, for other organisms ranged from 0.8% to 10.9%.
Interfering Substances: Hemoglobin: 9% inhibition, Bilirubin: 7% inhibition, Cholesterol: 0% inhibition, Triglyceride: -32% inhibition.
Limit of Detection (LoD): LoD was determined at an OD value of 0.558 and unit value of 11.3, with 95.8% positivity (24 replicates) for the 3.3 fold diluted positive sample.
Clinical Comparison:
Percent positive agreement: 94.5% (C.I. 76.0% - 100%)
Percent negative agreement: 93.8% (C.I. 88.8% - 99.5%)
Overall agreement: 94.0% (C.I. 85.9% - 100%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo for Gold Standard Diagnostics. The logo is in black and white and features the company name in a bold, sans-serif font. To the right of the logo is the number K110899. Below the logo is the date FEB - 1 2012.
510(k) Summary of Safety and Effectiveness
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.
-
- Submitter's Name: Gold Standard Diagnostics 2851 Spafford St. Davis, CA. 95618 Address: Phone Number: 530-759-8000 Contact Person: Napoleon Monce September 20, 2011 Date:
-
- Product and Trade Name: Helicobacter pylori IgA ELISA
Common Name or Classification Name: Campylobacter pylori
Product Code: LYR
3) Legally marketed device to which the submitter claims equivalence:
Micro Detect, Inc. Pylori Detect IgA ELISA for the qualitative detection of IgA antibodies against H. pylori in human serum. The test is intended as an aid in the diagnosis of infection by H. pylori in patients with gastrointestinal symptoms. K003794.
4) Description of the device:
The assay requires a total of 90 minutes incubation time. The test uses purified antigen coated on microtiter wells. Serum is added to each well and incubated for 30 minutes at 37°C. If H. pylori IgA antibodies are present they will bind to the antigen in the well. Unbound serum is removed by washing the wells three times. An HRP-conjugated anti-human IgA is then added to each well and incubated for 30 minutes at 37°C. If H. pylori antibody is present, it will bind to the antibody attached to the antigen on the wells are again washed three times to remove any unbound conjugate. A TMB substrate is added to each well and incubated for 30 minutes at 37°C. If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, Stop Solution and the color intensity is measured the reaction is stopped with a spectrophotometrically.
5) Intended use of the device:
The Helicobacter pylori (H. pylori) ELISA IgA test kit is intended for the qualitative detection of IgA antibodies to H, pylori in human serum in the adult population. This test is intended as a second test to aid in the diagnosis of H. pylori in patients with gastrointestinal symptoms, in conjunction with
1
clinical findings. It should be performed and interpreted with another assay for detection of IgG antibodies to H. pylori.
6) Comparison with the predicate device:
The Gold Standard Diagnostics H. pylori ELISA IgA Test Kit was compared to a commercially marketed kit by Micro Detect, Inc. the Pylori Detect IgA (K003794) catalog number HpKi-A. Both kits have the same intended use and use the same methodology. Below are tables comparing the reagents provided, the procedures, and their performances.
Table 1: Reagent Comparison
| Gold Standard Diagnostics H. pylori
| ELISA IgA Test Kit | Micro Detect Inc. Pylori Detect IgA |
|---|---|
| Antigen coated Microtiter Plate – 96 wells | Antigen coated Microtiter Plate – 96 wells |
| Wash Solution - 20x | Diluent/Wash Concentrate -- 25x |
| Diluent - Ready to Use | Diluent/Wash Concentrate - 25x |
| IgA Conjugate – Anti Human HRP | IgA Conjugate - Anti Human Peroxidase |
| Substrate - Tetramethylbenzidine (TMB) | Substrate - Tetramethylbenzidine (TMB) |
| Stop Solution - Acid mixture | Stop Solution - Sulfuric Acid |
| H. pylori IgA Positive Control | H. pylori IgA Positive Control |
| H. pylori IgA Cutoff Control | H. pylori IgA Calibrator |
| H. pylori IgA Negative Control | H. pylori IgA Negative Control |
Table 2: Procedure Comparison
| Gold Standard Diagnostics H. pylori
| ELISA IgA Test Kit | Micro Detect Inc. Pylori Detect IgA |
|---|---|
| Dilute Samples 1:101 in Diluent | Dilute Samples 1:101 in reconstituted |
| Diluent/Wash | |
| Add 100ul of Samples and Controls | Add 100ul of Samples and Controls |
| Incubate for 30 minutes at 37°C | Incubate for 20 minutes at Room |
| Temperature |
2
| Wash four times with reconstituted Wash
Solution | Wash three times with reconstituted Wash
Solution |
|-----------------------------------------------------|------------------------------------------------------|
| Add 100ul of Conjugate | Add 100ul of Conjugate |
| Incubate for 30 minutes at 37°C | Incubate for 20 minutes at Room
Temperature |
| Wash four times with reconstituted Wash
Solution | Wash three times with reconstituted Wash
Solution |
| Add 100ul of Substrate | Add 100ul of Substrate |
| Incubate for 30 minutes at 37°C | Incubate for 15 minutes at Room
Temperature |
| Add 50ul of Stop Solution | Add 100ul of Stop Solution |
| Read with Spectrophotometer at 450nm | Read with Spectrophotometer at 450nm |
6(b1) Nonclinical tests:
The intra and inter assay precision was calculated by running six patient sera (four positives and two negatives) at three different sites. The results are summarized in the table below:
| Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | ||
|---|---|---|---|---|---|---|---|
| Site 1 | Ave: | 0.945 | 0.803 | 0.860 | 0.498 | 0.091 | 0.115 |
| SD: | 0.024 | 0.034 | 0.039 | 0.025 | 0.006 | 0.008 | |
| Intra-Assay | CV: | 2.5% | 4.2% | 4.5% | 5.0% | 6.3% | 7.1% |
| Site 2 | Ave: | 1.030 | 0.737 | 0.716 | 0.579 | 0.091 | 0.137 |
| SD: | 0.060 | 0.057 | 0.041 | 0.046 | 0.004 | 0.009 | |
| Intra-Assay | CV: | 5.9% | 7.7% | 5.7% | 7.9% | 4.8% | 6.9% |
| Site 3 | Ave: | 0.996 | 0.667 | 0.768 | 0.579 | 0.091 | 0.151 |
| SD: | 0.108 | 0.035 | 0.057 | 0.042 | 0.010 | 0.009 | |
| Intra-Assay | CV: | 10.8% | 5.3% | 7.4% | 7.3% | 12.2% | 6.1% |
| Ave: | 0.964 | 0.770 | 0.812 | 0.527 | 0.090 | 0.126 | |
| Inter-Assay | SD: | 0.062 | 0.063 | 0.074 | 0.049 | 0.007 | 0.017 |
| CV: | 6.4% | 8.1% | 9.1% | 9.4% | 7.4% | 13.7% |
3
Reproducibility:
The reproducibility of the assay was done by testing three samples in triplicate (a high negative, low positive and a moderate positive) for five days, twice a day, at three sites with two technicians per site. The results are summarized in the table below:
| 5 Day Average: | Sample 1 | Sample 2 | Sample 3 | ||
|---|---|---|---|---|---|
| Site 1 | Tech 1 | OD: | 0.614 | 0.724 | 1.545 |
| SD: | 0.045 | 0.066 | 0.091 | ||
| CV: | 7.3% | 9.1% | 5.9% | ||
| Site 1 | Tech 2 | OD: | 0.588 | 0.717 | 1.494 |
| SD: | 0.059 | 0.073 | 0.091 | ||
| CV: | 10.1% | 10.2% | 9.8% | ||
| Site 2 | Tech 1 | OD: | 0.594 | 0.704 | 1.546 |
| SD: | 0.034 | 0.045 | 0.082 | ||
| CV: | 5.7% | 6.4% | 5.3% | ||
| Site 2 | Tech 2 | OD: | 0.618 | 0.845 | 1.741 |
| SD: | 0.036 | 0.044 | 0.071 | ||
| CV: | 5.8% | 5.2% | 4.1% | ||
| Site 3 | Tech 1 | OD: | 0.356 | 0.480 | 1.046 |
| SD: | 0.048 | 0.087 | 0.128 | ||
| CV: | 13.4% | 18.0% | 12.2% | ||
| Site 3 | Tech 2 | OD: | 0.478 | 0.636 | 1.323 |
| SD: | 0.086 | 0.110 | 0.148 | ||
| CV: | 18.0% | 17.3% | 11.2% |
Cross Reactivity:
An adsorption study was performed to evaluate any cross reactivity. Briefly, sera with different levels of antibodies to H. pylori were adsorbed with either H. pylori, Candida albicans, E. coli, Borrelia burgdorferi, Clostridium spp., Campylobacter, Bacillus, Enterobacter, Pseudomonas, Haemophilus Influenza, and Proteus. The identity of the bacteria used were identified by the ATCC and confirmed with mass spectrometry. The bacteria were evaluated at a concentration of 10' cfulml or higher.
Sera with different levels of antibodies to H. pylori, were adsorbed with the recommended organisms. The adsorbed samples were compared to the untreated samples and the mean percent inhibition was calculated. The results are summarized in the following table:
| Organism | Concentration
(cfu/ml) | Mean percent
inhibition | Cross
Reactivity |
|----------------------------|---------------------------|----------------------------|---------------------|
| Helicobacter pylori | . | 96% | |
| Candida albicans | 2.40x107 | 0.8% | None |
4
| Escherichia coli | 6.90x107 | 2.4% | None |
|---|---|---|---|
| Borrelia burgdorferi | 1.00x108 | 4.3% | None |
| Clostridium spp. | 1.20x107 | 1.7% | None |
| Campylobacter | 1.50x109 | 3.3% | None |
| Bacillus | 4.40x107 | 10.9% | None |
| Enterobacter | 1.80x108 | 4.1% | None |
| Pseudomonas | 1.45x108 | 3.8% | None |
| Haemophilus | |||
| Influenza | 7.90x107 | 5.8% | None |
| Proteus | 1.40x108 | 3.1% | None |
The mean percent inhibition for H. pylori was 96%, and 0.8% to 10.9% with the other organisms. Overall no effects on the analytical specificity were seen on the Gold Standard Diagnostics H. pylori ELISA IgA assay.
Interfering Substance
The effect of potential interfering substances on samples using the Gold Standard Diagnostics H. pylori ELISA IgA assay was evaluated. High levels of hemoglobin, bilirubin, cholesterol and triglycerides in serum samples were tested at the assay cutoff (9-11 units) in triplicate. The recommended concentrations from the guideline "Interference Testing In Clinical Chemistry" from the Clinical and Laboratory Standards Institute were used (see table below). No interference was noted with any of substances tested and the substances tested did not affect the performance of the Gold Standard Diagnostics H. pylori ELISA IgA assay.
| Substance | Concentration | H. pylori
concentratio
n | Mean Percent
Inhibition |
|--------------|----------------|--------------------------------|----------------------------|
| Hemoglobin | 2 g/L | 9-11 units | 9% |
| Bilirubin | 342 [Mu]mol/L | 9-11 units | 7% |
| Cholesterol | 13 mmol/L | 9-11 units | 0% |
| Triglyceride | 37 mmol/L | 9-11 units | -32% |
5
Leukocytes, intestinal secretions or mucus, fat, and medications used to relieve diarrhea or other gastric symptoms were not tested, therefore, it is not known if these substances will interfere with the assay as they were not evaluated.
Limit of Detection
To determine the Limit of Detection (LoD) for the assay, a pooled positive and a pooled negative sample were tested along with the negative, cutoff and positive controls provided in the kit. Further, the pooled positive sample was diluted up to 4.3 fold. The samples, and dilutions, were then tested 24 times (24 replicates) over several days as described in the Clinical Laboratory Standards Institute CLSI document EP-17. The LoD chosen was one that gave a positive result 95% of the time, was near the cutoff, and gave acceptable precision and accuracy results.
In Summary, the controls supplied in the kit were within their acceptable ranges. The pooled negative sample gave negative results on all 24 replicates giving an average OD value of 0.050 and a corresponding Unit value of 1.1. The pooled positive sample gave positive results on all 24 replicates giving an average OD value of 1.259 and a corresponding Unit value 25.3.
The pooled positive sample was then diluted up to 4.3 fold and each dilution was tested with the assay. The 3.3 fold dilution was positive 95.8% of the time (after 24 replicates), gave acceptable precision and accuracy results, gave an average OD value of 0.558 was close to the average cutoff OD value (0.497) and gave a corresponding unit value of 11.3. Therefore, we can conclude that the LoD of the Gold Standard Diagnostics H. pylori IgA Test can be determined at an OD value of 0.558 and unit value of 11.3.
6(b2): Clinical Comparison:
The performance of the Gold Standard Diagnostics H. pylori ELISA IgA assay was determined by conducting a correlation study using 625 samples being routinely tested for H. pylori. The samples were tested on both the Gold Standard Diagnostics H. pylori ELISA IgA assay and a commercially available ELISA assay (Micro Detect Inc. K003794) as the predicate device. The results are summarized in the following table:
Micro Detect Inc.
| Positive | Equivocal | Negative | ||
|---|---|---|---|---|
| Positive | 121 | 31 | 26 | |
| GSD | Equivocal | 13 | 8 | 23 |
| Negative | 7 | 5 | 394 |
The discrepant samples were further tested on a third assay, the Inova QUANTA Lite™ H. pylori IgA ELISA (which is also commercially available). Of the seven Gold Standard Diagnostics negative samples, Micro Detect Inc. positive samples, the third assay called five samples positive. Of the 26 Gold Standard Diagnostics positive samples, Micro Detect Inc. negative samples, the third assay called two samples borderline, one sample negative and 23 samples positive.
6
The comparison data produced a percent positive agreement of 94.5% (C.1. 76.0% - 100%), a percent negative agreement of 93.8% (C.I. 88.8% - 99.5%), and an overall agreement of 94.0% (C.I. 85.9% -100%).
6(b3) Conclusion:
From the data and comparison above, it is our contention that the Gold Standard Diagnostic H. pylori IgA ELISA test is substantially equivalent to the commercially marketed Micro Detect, Inc. Pylori Detect IgA kit.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a bird or a human figure in motion, composed of flowing lines. The symbol is black, and the text is also in a dark color, set against a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB - 1 2012
Gold Standard Diagnostics C/o Napoleon Monce Director, Product Development 2851 Spafford Street Davis, CA 95618
Re: K110899
Trade/Device Name: Gold Standard Diagnostics Helicobacter pylori IgA Test Kit Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR Dated: January 18, 2012 Received: January 19, 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
8
Page 2 – Mr. Monce
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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,
Sally A. Horvat, 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
9
Indications for Use
510(k) Number (if known): K110899
Device Name: Gold Standard Diagnostics Helicobacter pylori ELISA IgA Test Kit
Indications For Use:
The Helicobacter pylori (H. pylori) ELISA IgA test kit is intended for the qualitative detection of IgA antibodies to H. pylori in human serum in the adult population. This test is intended as a second test to aid in the diagnosis of H. pylori in patients with gastrointestinal symptoms, in conjunction with clinical findings. It should be performed and interpreted with another assay for detection of IgG antibodies to H. pylori.
Prescription Use X (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)
Freddie K. Poole
sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110899
Page 1 of
l . I