(329 days)
Not Found
No
The summary describes standard enzymatic photometric tests for quantitative determination of enzyme activity, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic reagent used to measure enzyme activity in patient samples for diagnostic purposes, not to provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the measurements provided by the reagents are "used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases" for alkaline phosphatase, and "used primarily for the diagnosis and treatment of pancreatitis" for amylase, and "used in the diagnosis and treatment of certain types of liver and heart disease" for aspartate aminotransferase. This clearly indicates a diagnostic purpose. The device also quantifies biomarkers to aid in diagnosis, which is indicative of a diagnostic device.
No
The device description clearly states it is a "reagent cartridge used with the S40 Clinical Analyzer," indicating it is a physical component (reagent) used in conjunction with a hardware analyzer, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for each reagent explicitly states: "For in vitro diagnostic use only."
- Intended Use: The reagents are intended for the quantitative determination of specific analytes (alkaline phosphatase, amylase, and aspartate aminotransferase) in human biological samples (serum or heparin plasma). This is a core function of IVD devices.
- Clinical Purpose: The measurements are used in the diagnosis and treatment of various diseases (liver, bone, parathyroid, intestinal, pancreatitis, heart disease). This indicates a medical purpose for the test results.
- Care Setting: The intended users are clinical laboratories or physician office laboratories, which are typical settings for performing in vitro diagnostic tests.
- Device Description: The device description further clarifies that the reagent cartridges are "intended for quantitative in vitro diagnostic determination" of the analytes.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes
CJI, JFJ, CIT
Device Description
The S-Test alkaline phosphatase (ALP) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALP activity in serum or heparin plasma based on an enzymatic photometric test using p -nitrophenyl phosphate as a substrate.
The S-Test amylase (AMY) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of amylase activity in serum or heparin plasma based on an enzymatic photometric test using 2-chloro-4-nitrophenyl-α-galactopyranosyl maltoside (Gal-G2-CNP) as a substrate.
The S-Test aspartate aminotransferase (AST) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of AST in serum or heparin plasma based on an enzymatic photometric test using L-aspartate and α-ketoglutarate as substrates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Precision:
S-Test ALP: In testing conducted at three ALP levels for 22 days, the within-run CV ranged from 2.2 to 3.5%, and total CV ranged from 5.4 to 5.7%. In precision studies at three separate Physician Office Laboratories (POL) sites and in-house over five days, the within-run CV ranged from 1.5 to 4.4%, and the total CV ranged from 1.5 to 4.9%.
S-Test AMY: In testing at three amylase levels for 22 days, the within-run CV ranged from 1.7 to 2.4%, and total CV ranged from 6.4 to 8.2%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.0 to 6.4%, and the total CV ranged from 1.0 to 6.6%.
S-Test AST: In testing at three AST levels for 22 days, the within-run CV ranged from 0.8 to 2.5%, and total CV ranged from 4.4 to 4.9%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 0.8 to 4.8%, and the total CV ranged from 0.9 to 7.0%.
Accuracy:
S-Test ALP: In the correlation study, 180 samples with ALP values ranging from 28 to 733 U/L were assayed on the S40 Clinical Analyzer using S-Test-ALP reagent and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.997, a standard error estimate of 10.9, a confidence interval slope of 0.929 to 1.009, and a confidence interval intercept of -4.43 to 2.02. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranging from 0.996 to 0.998, standard error estimates of 10.4 to 14.3, confidence interval slopes of 0.963 to 1.011, and confidence interval intercepts of -2.5 to 15.6.
S-Test AMY: In the correlation study, 196 samples with amylase values ranging from 9 to 1461 U/L were assayed on the S40 Clinical Analyzer using S-Test Amylase and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.997, a standard error estimate of 21.0, a confidence interval slope of 0.932 to 1.005, and a confidence interval intercept of 0.56 to 5.81. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparison method, least-squares regression analysis yielded correlation coefficients of 0.997, standard error estimates of 35.6 to 37.0, confidence interval slopes of 0.914 to 0.960, and confidence interval intercepts of -7.4 to 21.6.
S-Test AST: In the correlation study, 177 samples with AST values ranging from 10 to 333 U/L were assayed using S-Test AST and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.998, a standard error estimate of 4.5, a confidence interval slope of 0.986 to 1.042, and confidence interval intercept of -1.75 to 0.09. In patient correlation studies at four separate POL sites over five days using the S40 Clinical Analyzer and a comparison method, least-squares regression analysis yielded correlation coefficients of 0.998, standard error estimates of 6.3 to 6.7, confidence interval slopes of 1.041 to 1.110, and confidence interval intercepts of -7.7 to 4.9.
Sensitivity:
S-Test ALP: The detection limit was 20 U/L.
S-Test AMY: The detection limit was 8 U/L.
S-Test AST: The detection limit was 8 U/L.
Key Metrics
Not Found
Predicate Device(s)
ACE plus ISE/ Clinical Chemistry System (K931786), Olympus AU640 Clinical Chemistry Analyzer (K961274), Piccolo® xpress Chemistry Analyzer (K942782)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
510(k) SUMMARY
JUN 2 6 2008
| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Dennis Taschek
Phone: 973-852-0177
Fax: 973-852-0237 |
| Date Summary
Prepared: | June 19, 2008 | |
| Device: | Trade Name: | S-Test ALP; S-Test AMY; S-Test AST Reagent
cartridge
(21 C.F.R. § 862.1050, Product code CJI; 21
C.F.R. § 862.1070, Product code JFJ; 21 C.F.R.
§ 862.1100, Product code CIT) |
| | Classification: | Class II |
| | Common/Classification
Name: | Alkaline phosphatase; amylase; aspartate
aminotransferase test systems |
| Predicate
Devices | Manufacturers for analyzer/reagent system predicates are: | |
| | 1. | ACE plus ISE/ Clinical Chemistry System |
| | | ACE Alkaline Phosphatase Reagent (K931786) |
| | | ACE Amylase Reagent (K931786) |
| | | ACE Aspartate Aminotransferase Reagent (K931786) |
| | 2. | Olympus AU640 Clinical Chemistry Analyzer |
| | | Alkaline Phosphatase Reagent (K961274) |
| | | Amylase Reagent (K961274) |
| | | Aspartate Aminotransferase Reagent (K961274) |
| | 3. | Piccolo® xpress Chemistry Analyzer |
| | | Alkaline Phosphatase Reagent (K942782) |
| | | Amylase Reagent (K942782) |
| | | Aspartate Aminotransferase Reagent (K942782) |
| Device Description: | The S-Test alkaline phosphatase (ALP) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALP activity in serum or heparin plasma based on an enzymatic photometric test using p -nitrophenyl phosphate as a substrate. | |
| | The S-Test amylase (AMY) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of amylase activity in serum or heparin plasma based on an enzymatic photometric test using 2-chloro-4-nitrophenyl-α-galactopyranosyl maltoside (Gal-G2-CNP) as a substrate. | |
| | The S-Test aspartate aminotransferase (AST) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of AST in serum or heparin plasma based on an enzymatic photometric test using L-aspartate and α-ketoglutarate as substrates. | |
| Intended Use: | The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| | The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| | The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| Technological
Characteristics: | The S-Test ALP is a bi-reagent cartridge. Reagent 1 is ethyl amino ethanol
buffer and magnesium chloride. Reagent 2 is p-nitrophenyl phosphate (46
mmol/L).
The S-Test AMY is a bi-reagent cartridge. Reagent 1 contains: sodium
chloride, calcium chloride, and Good's buffer (pH 6.0). Reagent 2 contains: α-
2-chloro-4-nitrophenyl galactopyranosyl maltoside, potassium thiocyanate, and
Good's buffer (pH 6.0).
The S-Test AST reagent is a bi-reagent cartridge. Reagent 1 contains:
nicotinamide-adenine dinucleotide (reduced form), malate dehydrogenase
(derived from Thermus), 2-amino-2-hydroxymethyl-1,3-propanediol buffer
(pH 7.8, 30°C), and L-aspartic acid. Reagent 2 contains: L-aspartic acid, α-
ketoglutaric acid, and 2-amino-2-hydroxymethyl-1,3-propanediol buffer (pH
7.8, 30°C). | |
| Performance
Data: | Performance data on the S-Test ALP, S-Test AMY, and S-Test AST, and
included precision, accuracy, and sensitivity data.
S-Test ALP
Precision: In testing conducted at three ALP levels for 22 days, the within-run
CV ranged from 2.2 to 3.5%, and total CV ranged from 5.4 to 5.7%. In
precision studies at three separate Physician Office Laboratories (POL) sites
and in-house over five days, the within-run CV ranged from 1.5 to 4.4%, and
the total CV ranged from 1.5 to 4.9%.
Accuracy: In the correlation study, 180 samples with ALP values ranging
from 28 to 733 U/L were assayed on the S40 Clinical Analyzer using S-Test-
ALP reagent and a comparison method. Least-squares regression analysis
yielded a correlation coefficient of 0.997, a standard error estimate of 10.9, a
confidence interval slope of 0.929 to 1.009, and a confidence interval intercept
of -4.43 to 2.02. In patient correlation studies at four separate POL sites using
the S40 Clinical Analyzer and a comparative method, least-squares regression
analysis yielded correlation coefficients ranging from 0.996 to 0.998, standard
error estimates of 10.4 to 14.3, confidence interval slopes of 0.963 to 1.011,
and confidence interval intercepts of -2.5 to 15.6.
Sensitivity: The detection limit was 20 U/L.
S-Test AMY
Precision: In testing at three amylase levels for 22 days, the within-run CV
ranged from 1.7 to 2.4%, and total CV ranged from 6.4 to 8.2%. In precision
studies at three separate POL sites and in-house over five days, the within-run
CV ranged from 1.0 to 6.4%, and the total CV ranged from 1.0 to 6.6%
Accuracy: In the correlation study, 196 samples with amylase values ranging
from 9 to 1461 U/L were assayed on the S40 Clinical Analyzer using S-Test
Amylase and a comparison method. Least-squares regression analysis yielded | |
| a correlation coefficient of 0.997, a standard error estimate of 21.0, a
confidence interval slope of 0.932 to 1.005, and a confidence interval intercept
of 0.56 to 5.81. In patient correlation studies at four separate POL sites using
the S40 Clinical Analyzer and a comparison method, least-squares regression
analysis yielded correlation coefficients of 0.997, standard error estimates of
35.6 to 37.0, confidence interval slopes of 0.914 to 0.960, and confidence
interval intercepts of -7.4 to 21.6. | | |
| Sensitivity: The detection limit was 8 U/L.
S-Test AST | | |
| Precision: In testing at three AST levels for 22 days, the within-run CV ranged
from 0.8 to 2.5%, and total CV ranged from 4.4 to 4.9%. In precision studies
at three separate POL sites and in-house over five days, the within-run CV
ranged from 0.8 to 4.8%, and the total CV ranged from 0.9 to 7.0%. | | |
| Accuracy: In the correlation study, 177 samples with AST values ranging
from 10 to 333 U/L were assayed using S-Test AST and a comparison method.
Least-squares regression analysis yielded a correlation coefficient of 0.998, a
standard error estimate of 4.5, a confidence interval slope of 0.986 to 1.042,
and confidence interval intercept of -1.75 to 0.09. In patient correlation studies
at four separate POL sites over five days using the S40 Clinical Analyzer and a
comparison method, least-squares regression analysis yielded correlation
coefficients of 0.998, standard error estimates of 6.3 to 6.7, confidence interval
slopes of 1.041 to 1.110, and confidence interval intercepts of -7.7 to 4.9. | | |
| Sensitivity: The detection limit was 8 U/L. | | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also
indicate substantial equivalence to the predicate devices. | |
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 6 2008
Alfa Wassermann Diagnostic Technologies, Inc. c/o Mr. Daivd Slavin Vice President. Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
Rc: K072142
Trade/Device Name: S Test Alkaline Phosphatase (ALP) Reagent cartridge, S Test Amylase (AMY) Reagent cartridge and S Test Aspartate Aminotransferase (AST) Reagent cartridge Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline Phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CKF, CIJ, CIT Dated: June 16, 2008 Received: June 17, 2008
Dear Mr. Slavin
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072142
S40 Clinical Analyzer S-Test ALP S-Test AMY S-Test AST
Indications for Use
510(k) Number K072142 (if known):
Device Name: S-Test Alkaline Phosphatase (ALP)
The S-Test Alkaline Phosphatase Reagent is intended for the quantitative Indications for Use: determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
SAN A. pedini
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K079149
June 3, 2008
CONFIDENTIAL
7
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072142
S40 Clinical Analyzer S-Test ALP S-Test AMY S-Test AST
Indications for Use
510(k) Number K072142 (if known):
Device Name: S-Test Amylase (AMY)
Indications for Use: The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
LAVP acting
CONFIDENTIAL
Office of In Vitro Diagnostic
Device Evaluation and Safety
L 518/49
June 3, 2008
8
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072142
S40 Clinical Analyzer S-Test ALP S-Test AMY S-Test AST
Indications for Use
| 510(k) Number
| (if known): | K072142 |
|---|---|
| Device Name: | S-Test Aspartate Aminotransferase (AST) |
| Indications for Use: | The S-Test Aspartate Aminotransferase Reagent is intended for the |
| quantitative determination of aspartate aminotransferase activity in serum | |
| or heparin plasma using the S40 Clinical Analyzer. Aspartate | |
| aminotransferase measurements are used in the diagnosis and treatment of | |
| certain types of liver and heart disease. This test is intended for use in | |
| clinical laboratories or physician office laboratories. For in vitro | |
| diagnostic use only. |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED |
|---|
| --------------------------------------------------------------------------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
luation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
June 3, 2008
CONFIDENTIAL