(31 days)
No
The description focuses on capillary electrophoresis and visual evaluation of electrophoregrams, with no mention of AI or ML.
No.
The device is for in vitro diagnostic use, specifically for detecting and characterizing monoclonal proteins in human serum, and does not directly treat or prevent a disease.
Yes
The device is designed for the detection and characterization of monoclonal proteins in human serum, which is used to indicate a gammopathy. This falls under the definition of a diagnostic device as it provides information for the diagnosis of a medical condition.
No
The device description explicitly details hardware components (MINICAP and MINICAP FLEX-PIERCING instruments, capillaries, detection at 200 nm) and physical processes (capillary electrophoresis, mixing with antisera, high voltage separation). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Purpose: The device is designed for the detection and characterization of monoclonal proteins in human serum, which is a diagnostic test performed outside of the body (in vitro).
- Method: It uses capillary electrophoresis to analyze components of a biological sample (human serum).
- Clinical Relevance: The results are used to identify and characterize monoclonal proteins, which are indicative of gammopathies, a type of blood disorder.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The MINICAP and MINICAP FLEX-PIERCING instruments perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains. respectively.
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins.
For In Vitro Diagnostic Use.
Product codes
CFF, DFH, DEH, CEF
Device Description
The MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoresis mobility in an alkaline buffer. The separation occurs according to the electrolyte pH and electro-osmotic flow. In capillary electrophoresis abnormal fractions in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones are always suspected of being monoclonal proteins, paraproteins, monoclonal immunoglobulins) and therefore an indication of a gammopathy. The MINICAP FLEX-PIERCING instrument has 2 capillaries functioning in parallel. A sample dilution is prepared and injected simultaneously by aspiration at the anodic end of the 2 capillaries.
The Immunotyping procedure follows the steps in which the sample is mixed with an ELP solution (reference pattern), specific antisera gamma ( IgG), mu (IgM) heavy chains and free/bound Kappa and Lambda light chains.
A high voltage protein separation is then performed and direct detection of the proteins at 200 nm at the cathodic end of the capillary. The capillaries are then washed and prepared for the next analysis. The superimposition of the antisera patterns with the ELP pattern allows for the visualization of the disappearance and /or the decrease of the monoclonal fraction on the antiserum pattern and to indicate a gammopathy.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
- Ig A, L: Alpha Lambda, 2.7 Concentration (g/dL), 25 Detection Limit (mg/dL)
- Ig G, K: Gamma Kappa, 2.9 Concentration (g/dL), 25 Detection Limit (mg/dL)
- Ig M, K: Mu Kappa, 1.7 Concentration (g/dL), 25 Detection Limit (mg/dL)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
SEBIA INC. C/O MS. KAREN ANDERSON DIRECTOR OF TECHNICAL AND QUALITY ASSURANCE SUITE 400, 1705 CORPORATE DRIVE NORCROSS GA 30093
Re: K143483
Trade/Device Name: MINICAP Immunotyping Using the MINICAP and the MINICAP FLEX-PIERCING Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: CFF, DFH, DEH, CEF Dated: December 8, 2014 Received: December 9, 2014
Dear Ms. Anderson:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Leonthena R. Carrington -A
Leonthena Carrington, MS, MBA, MT(ASCP) Director (Acting) Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143483
Device Name
MINICAP IMMUNOTYPING USING THE MINICAP AND THE MINICAP FLEX-PIERCING
Indications for Use (Describe)
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The MINICAP and MINICAP FLEX-PIERCING instruments perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains. respectively.
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins.
For In Vitro Diagnostic Use.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
SPECIAL 510k SUMMARY
Purpose for Submission
Sebia hereby submits this Special 510k to provide notification of the modification to our MINICAP IMMUNUNOTYPING procedure. The MINICAP IMMUNOTYPING reagent kit was originally cleared for use with the MINICAP instrument, K082388 April 14, 2009.
This modification includes a new instrument family member, MINICAP FLEX-PIERCING.
Modifications to the test system include:
- New instrument family member MINICAP FLEX-PIERCING instrument using the MINICAP ● IMMUNOTYPING procedure.
A full description of the differences and similarities between performance of the MINICAP IMMUNOTYPING procedure using the MINICAP and MINICAP FLEX-PIERCING instruments is described below.
The MINICAP FLEX-PIERCING analyzer is a new member of the MINICAP family of analyzers and will use the same reagents as cleared with the MINICAP IMMUNOTYPING device.
The devices have the same intended use, detection and characterization of monoclonal proteins (immunotyping) in human serum using capillary electrophoresis.
Both devices are based on the same principles and technique following the process of:
- Each serum sample is mixed with the individual antisera that are specific aqainst .. gamma ( IgG), alpha ( IgA), mu ( IgM) heavy chains and kappa and lambda ( free and bound) light chains.
- The proteins are separated in silica capillaries and directly detected by their absorbance ii. at 200 nm
- The electrophorograms are evaluated to detect the presence of specific reactions with iii. the suspected monoclonal proteins using PHORESIS software.
The MINICAP FLEX-PIERCING instrument was 510(k) cleared for an alternant assay MINICAP Hb A1c that has similar technical characteristic and the same software but a different sample matrix. The MINICAP Hb A1c was cleared under K133344, March 28, 2014
In accordance with the FDA policies, with this new application of the MINICAP IMMUNOTYPING assay using the MINICAP FLEX-PIERCING instrument, new labeling was added to the package insert. Sebia is following the FDA guidance to demonstrate the equivalence to the original reagent and instrument performance by using the Special 510(k) notification process.
The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied. The results indicate that the intended use, qualitative interpretation of the patterns were found substantially equivalent to the original device. The results demonstrate that the risk analysis demonstrates no adverse effects on the qualitative results obtained.
4
The Objectives of the modification was to:
- Enable the MINICAP IMMUNOTYPING procedure to be run on another instrument (i) family member the MINICAP FLEX-PIERCING instrument was adapted for capped tube whole blood testing for MINICAP HbA1c technique and was cleared as K133344, March 28, 2014.
This objective was achieved by demonstrating the modifications that were adapted for the capped tube whole blood testing for MINICAP HbA1c testing at 415 nm did not affect the performance of the MINICAP IMMUNOTYPING procedure that uses serum and testing at 200 nm using uncapped tubes.
Acceptance criteria for the modified device were predetermined as follows:
-
- The same intended use claim as the unmodified device
-
- Substantial equivalency to the predicate device for the detection and characterization of the monocloncal proteins (immunotyping) in human serum.
-
- Performance characteristics within predetermined criteria.
Completed detailed sets of data are on file at Sebia manufacturing
Device Name and Classification
Proprietary name: MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING
Common name : Monoclonal Immunoglobulins by Capillary Electrophoresis
Classification: Class II
Product Regulation 21 CFR Part 866.5510 Immunoglobulins (A, G, M, D, E) Immunoglobulin test system 21 CFR Part 866.5550 Immunoglobulin (light chain specific) immunoglobulin test system 21 CFR Part 862.1630 Electrophoretic, Protein Fractionation
Product Code: CFF- Immunoelectrophoretic, Immunoglobulines ( G, A, M) DFH- Kappa. Antigen. Antiserum Control DEH- Lambda, Antigen, Antiserum Control CEF- Electrophoreic, Protein Fractionation
Establishment Registration: Sebia is registration with the FDA is 8023024
5
Device Description
The MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoresis mobility in an alkaline buffer. The separation occurs according to the electrolyte pH and electro-osmotic flow. In capillary electrophoresis abnormal fractions in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones are always suspected of being monoclonal proteins, paraproteins, monoclonal immunoglobulins) and therefore an indication of a gammopathy. The MINICAP FLEX-PIERCING instrument has 2 capillaries functioning in parallel. A sample dilution is prepared and injected simultaneously by aspiration at the anodic end of the 2 capillaries.
The Immunotyping procedure follows the steps in which the sample is mixed with an ELP solution (reference pattern), specific antisera gamma ( IgG), mu (IgM) heavy chains and free/bound Kappa and Lambda light chains.
A high voltage protein separation is then performed and direct detection of the proteins at 200 nm at the cathodic end of the capillary. The capillaries are then washed and prepared for the next analysis. The superimposition of the antisera patterns with the ELP pattern allows for the visualization of the disappearance and /or the decrease of the monoclonal fraction on the antiserum pattern and to indicate a gammopathy.
Performance Standards
To date, no performance standards exist for this device
Intended Use
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The MINICAP and MINICAP FLEX-PIERCING instruments perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (lg G), alpha (lg A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains, respectively.
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins.
For In Vitro Diagnostic Use.
Predicate device
We claim substantial equivalence to the MINICAP IMMUNOTYPING using the MINICAP instrument cleared as K082388.
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Substantial equivalency Similarities
The table below demonstrates the similarities and differences between the MINICAP IMMUNOTYPING using the MINICAP instrument as compared to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument.
| Feature | Predicate Device K082388
MINICAP IMMUNOTYPING using the MINICAP
Instrument | Modified Device
MINICAP IMMUNOTYPING using
MINICAP FLEX-PIERCING Instrument |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The MINICAP IMMUNOTYPING kit is designed for the
detection and the characterization of monoclonal proteins
( immunotyping) in human serum with the MINICAP System,
SEBIA, for capillary electrophoresis. It is used in conjunction
with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for
protein separation into 6 major fractions in alkaline buffer (pH
9.9).
The MINICAP performs all procedural sequences
automatically to obtain a protein profile for qualitative
analysis. Each serum sample is mixed with individual antisera
that are specific against gamma (IgG), alpha (IgA) and mu
(IgM) heavy chains, and kappa and lambda ( free and bound)
light chains, respectively.
The proteins, separated in silica capillaries are directly
detected bythe absorbance at 200 nm. The
electrophoregrams are evaluated visually to detect the
presence of specific reactions with the suspected monoclonal
proteins.
For In Vitro Diagnostic Use | The MINICAP IMMUNOTYPING kit is
designed for the detection and the
characterization of monoclonal proteins
( immunotyping) in human serum with the
MINICAP and MINICAP FLEX- PIERCING
instruments, SEBIA, for capillary
electrophoresis. It is used in conjunction
with the MINICAP PROTEIN(E) 6 kit,
SEBIA, designed for protein separation into
6 major fractions in alkaline buffer (pH 9.9).
The MINICAP and MINICAP FLEX-
PIERCING instruments perform all
procedural sequences automatically to
obtain a protein profile for qualitative
analysis. Each serum sample is mixed with
individual antisera that are specific against
gamma (IgG), alpha (IgA) and mu (IgM)
heavy chains, and kappa and lambda ( free
and bound) light chains, respectively.
The proteins, separated in silica capillaries
are directly detected by the absorbance at
200 nm. The electrophoregrams are
evaluated visually to detect the presence of
specific reactions with the suspected
monoclonal proteins.
For In Vitro Diagnostic Use |
| Methodology | Capillary electrophoresis | Same |
| Technology | Capillary electrophoretic migration with Immunofixation by
Subtraction( Immunotyping) | Same |
| Absorbance
Wavelength | 200 nm | Same |
| Sample Type | Serum | Same |
| Instrument
Name | MINICAP PN 1230 | MINICAP FLEX-PIERCING PN 1232 |
| Instrument | Image: Blue MINICAP instrument | Image: Green MINICAP FLEX-PIERCING instrument |
| | Blue Cover | Green Cover |
| Instrument
dimensions | 22.6 X 16.2 X 16.9 | 17.3 X 16.3 X 22.8 |
| Probe | Uncapped tubes only | Cap piercing |
| | | |
| Probe Shape
and Coating | Flat, Stainless Steel
Teflon | Pointed, Stainless Steel
slightly modified to enhance the hardiness
of the sample probe (addition of ceramic) |
| Detection | Deuterium lamp, network, U.V detector, optical fibers | Deuterium lamp, LED, network, U.V
detector, optical fibers |
| Lamp | Deuterium lamp | Deuterium lamp with shape changed to
allow space in the instrument for LED lamp
(not used with this technique) |
| Tube
requirement for
Immunotyping | Uncapped | Uncapped |
| Capped and
Uncapped
Tubes (test
dependent) | Not available for capped tubes | Yes |
| Loading of
sample tubes | Sample tubes loaded onto rotating sampler wheel | Same |
| Sampling | Samples taken directly from the tubes (8 to 16 mm in
diameter, 50 to 100 mm high)
or from 1.5 ml microtubes positioned on the primary sample
tubes.
Sample volume: 10 to 20 µL | Same |
| Number of
separation Units | 2 parallel capillaries | Same |
| Sample
identification | Yes, ( Bar code reading of sample tubes) | Same |
| Introduction of
samples into the
automatic
system | Continuous loading on the rotation sampler wheel | Same |
| Migration | Liquid-flow capillary electrophoresis in 2 silica capillary tubes.
Migrations takes place in fully controlled temperature
conditions using a Peltier device. | Same |
| Analysis
throughput | 2 samples/hour | Same |
| Software | PHORESIS | Same |
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8
| ITEMS | PN 2300 | |||||
|---|---|---|---|---|---|---|
| Reagent | ||||||
| Labeling and | ||||||
| composition | Sample diluent (ready to use) | |||||
| Rack with ELP solution and antiserum tubes | ||||||
| ELP solution (ready to use) | ||||||
| Mammalian Immunoglobulins anti-human gamma heavy chains (ready to use) | ||||||
| Mammalian Immunoglobulins anti-human alpha heavy chains (ready to use) | ||||||
| Mammalian Immunoglobulins anti-human mu heavy chains (ready to use) | ||||||
| Mammalian Immunoglobulins anti-human kappa (free and bound) light chains (ready to use) | ||||||
| Mammalian Immunoglobulins anti-human lambda (free and bound) light chains (ready to use) | 6 vials, 4.0 mL each | |||||
| 1 vial, 1.2 mL | ||||||
| 1 vial, 1.2 mL | ||||||
| 1 vial, 1.2 mL | ||||||
| 1 vial, 1.2 mL | ||||||
| 1 vial, 1.2 mL | ||||||
| 1 vial, 1.2 mL | Same | |||||
| Antisera | ||||||
| Specificity | Antibody specificity to heavy chains (IgG, IgA, IgM) and to light chains (Kappa, Lambda) | Same | ||||
| SAMPLE No. | MONOCLONAL COMPONENT | |||||
| TYPE | CONCENTRATION (g/dL) | |||||
| (in the original serum) | DETECTION LIMIT (mg/dL) | |||||
| Sensitivity | 1 | Ig A, L | Alpha | |||
| Lambda | 2.7 | 25 | Same | |||
| 2 | Ig G, K | Gamma | ||||
| Kappa | 2.9 | 25 | ||||
| 3 | Ig M, K | Mu | ||||
| Kappa | 1.7 | 25 | ||||
| Buffer pH | pH 9.9 | Same | ||||
| Serum Sample | ||||||
| volume required | ||||||
| for dilution: | ||||||
| dependants on | ||||||
| the | ||||||
| immunoglobulin | ||||||
| concentration | 2.0 g/dL Ig: 20 µL of serum to make 1:40 dilution | Same | ||||
| Results | Qualitative Interpretation | Same |
Proposed Labeling
The proposed labeling is attached in this submission. It includes:
-
- MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument
-
- MINICAP FLEX-PIERCING Instrument manual
Modifications to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument do not affect the intended use of the device as describe in the labeling, nor alter the fundamental scientific technology of the device. We trust that the information provided with this Special 510K will support the decision of substantial equivalence to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument.
If additional questions or information is required please contact: Karen Anderson, MT (ASCP)
Director of Technical and Quality Assurance Phone 1-800-835-6497 Fax 770 446 8511 or Aigars Brants , Ph,D Scientifc Affairs Officer 1-800-835-6497
Karen Anderson