DCA VANTAGE, MODEL 5075

K071466 · Siemens Medical Solutions Diagnostics · LCP · Oct 9, 2007 · Hematology

Device Facts

• Record ID: K071466
• Device Name: DCA VANTAGE, MODEL 5075
• Applicant: Siemens Medical Solutions Diagnostics
• Product Code: LCP · Hematology
• Decision Date: Oct 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The DCA Vantage™ is a semi-automated, benchtop system. It is designed to quantitatively measure the percent Hemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The measurement of hemoglobin A1c concentration is recommended for monitoring the longterm glycemic control of persons with diabetes. Testing for microalbuminuria (low concentration of albumin in urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). It is intended for use in both screening for, and monitoring treatment of, microalbuminuria. Measurement of creatinine is used as a calculation basis to adjust the albumin/creatinine ratio result for varying urine concentrations. The reporting of albumin/creatinine ratio is recommended for the early detection of kidney diseases. The DCA Vantage system is for use in laboratories such as: physician office laboratories, clinics, and hospitals. Tests performed using the DCA Vantage™ are intended for in vitro diagnostic use.

Device Story

Device modification of previously cleared system (K951361, K963142); additions include integrated printer, increased data storage, color LCD touch-screen interface, updated mechanical/electrical components, updated housing, and USB/Ethernet connectivity. Device operates as diagnostic/monitoring system; modifications maintain fundamental scientific technology. Used in clinical settings by healthcare professionals; output facilitates clinical decision-making via enhanced data management and interface capabilities.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence demonstrated through design control activities, risk analysis, and verification/validation of modified components.

Technological Characteristics

Spectrophotometer; analyzes intensity of monochromatic light through cartridge optical window. Features: color LCD touch-screen, integrated printer, USB/Ethernet connectivity. Safety standards: EN 60601-1, EN 60601-1-2, EN 55011, FCC Part 15, CAN/CSA C22.2 No. 601.1. Uses same test cartridges as DCA 2000+.

Indications for Use

Indicated for monitoring long-term glycemic control in patients with diabetes (HbA1c) and for screening/monitoring microalbuminuria in patients with insulin-dependent (IDDM) or non-insulin dependent (NIDDM) diabetes mellitus. Also indicated for early detection of kidney disease via albumin/creatinine ratio.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• K951361
• K963142

Submission Summary (Full Text)

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K071466

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.

| Submitter information | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------|--------------|
| Contact person: | Noor Malki<br>Manager, Regulatory Affairs & Compliance | OCT - 9 2007 |
| Address: | Siemens Medical Solutions Diagnostics<br>Point of Care (POC) Products<br>2 Edgewater Drive<br>Norwood, MA 02062 | |
| Phone: | 781-269-3401 | |
| Date summary prepared: | May 25, 2006 | |
| Device Information | | |
| Proprietary Name: | DCA Vantage™ | |
| Common Name: | Test system for hemoglobin A1c, albumin and creatinine | |
| Classification Name: | | |

- Glycosylated Hemoglobin Assay .
- Urinary protein or albumin test system .
- Creatinine test system .

| Predicate Device<br>Element | Predicate (unmodified device) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DCA 2000+ Analyzer |
| Classification Name<br>and<br>Title 21 CFR | Glycosylated Homoglobin Assay $\checkmark$ (864.7470)<br>Urinary Protein or Albumin Test System $\checkmark$ (862.1645)<br>Creatinine Test System (862.1225) |
| 510(k) Numbers | DCA 2000 System for Hemoglobin A1c (K951361) DCA 2000+ Microalbumin / Creatinine Assay (K963142) |
| Manufacturer | Bayer HealthCare LLC (currently Siemens Medical Solutions Diagnostics) |
| Class | I & II |
| Panel | Hematology & Pathology Devices<br>Clinical Chemistry & Clinical Toxicology |
| CLIA Complexity | DCA 2000+ Glycosylated Hemoglobin Assay - Waived<br>DCA 2000+ Microalbumin /Creatinine Assay - Moderate |

#### Predicate Device

Siemens Medical Solutions Diagnostics / Point of Care (POC) Products DCA Vantage™ Special 510(k)

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#### Device Description

The DCA Vantage is a device modification to the previously cleared DCA 2000+. It is a semi-automated, benchtop analyzer designed to quantitatively measure the percent Hemoglobin A1c (HbA1c) in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine.

Identical to the DCA 2000+, all testing takes place at the analyzer. User steps to introduce the sample to the cartridge and the cartridge to the analyzer are unchanged. To perform a test, the user needs to collect test sample in the capillary holder, insert holder into the cartridge, scan cartridge into the barcode track, place cartridge in its compartment, remove the flexible tab and close the door to automatically start the test. Test results are displayed on screen and measurement is completed in 6-7 minutes.

# Statement of Intended Use

The DCA Vantage™ is a semi-automated, benchtop system. It is designed to quantitatively measure the percent Hemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine.

# Summary of Technological Characteristics

Similar to the DCA2000+, the DCA Vantage is a spectrophotometer that analyzes the intensity of monochromatic light directed through the cartridge optical window and reports the results in clinically meaningful units. No calculations are required by the user. When an operator swipes a calibration card, the barcode reader reads the card and the system automatically sets the calibration.

The DCA Vantage operating principle, technical platform, instrument and reagent analytical method, test steps, as well as intended use remain the same as the DCA 2000+. In addition, the DCA Vantage utilizes the same test cartridges for HbA1c and Microalbumin / Creatinine currently used on the DCA 2000+.

Design modifications introduced in the DCA Vantage are the addition of integrated printer, increased data storage, improved color LCD touch-screen interface with expanded optional features, updated mechanical and electrical components, updated housing, and the addition of USB/Ethernet connection.

# Assessment of Performance

An internal study was conducted to demonstrate the performance of the DCA Vantage™ analyzer (modified device) and assess its substantial equivalence against the DCA 2000+ (unmodified device/predicate device).

Over the study duration, a total of fifty (50) whole blood and fifty (50) urine specimens were evaluated for HbA1c , and microalbumin/creatinine, respectively. All specimens were evaluated on both the DCA Vantage and the DCA 2000+. Based on the data

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collected it was concluded that the DCA Vantage meets accuracy requirements using Linear Regression for HbA1c , Albumin, Creatinine, and Albumin Creatinine ratio relative to the DCA 2000+ using clinical specimens. In addition, the DCA Vantage meets the precision performance requirements for HbA1c, Albumin, and Creatinine relative to the DCA 2000+ using quality controls.

Utilizing the established Risk Management process, design modifications introduced in the DCA Vantage underwent a FMECA analysis. As a result, hazards identified were addressed in the design verification and validation testing.

In addition information on Software Development Life Cycle including software requirements specifications, risk management report, and overall verification and validation results were included to provide additional assurance of device performance.

# Compliance to Standards

The DCA Vantage is designed and fully meets the following international safety standards:

- EN 60601-1-2:2001 Electromagnetic emissions and immunity requirements for . medical electrical equipment - group 1 Equipment Class B for non-life supporting equipments
- EN 60601-1: 1990 + A1:1993 + A2:1995+ A13:1996 .
- EN 55011:1998/A1:1999/A2:2002 Industrial, scientific and medical (ISM) radio . frequency equipment — Radio disturbance characteristics - Limits and methods of measurement - Group 1 Class B ISM emissions requirements
- . IEC 60601-1:1988 + A1:1991 + A2:1995 - Medical Electrical Equipment Part 1: General requirements for safety
- FCC 47 CFR Part 15 Class B emission requirements .
- . CAN/CSA C22.2 No. 601.1-M90 (R1997)

# Conclusion

In conclusion, results of performance testing, verification and validation activities demonstrate that the design modifications introduced with the DCA Vantage do not impact safety and effectiveness. The DCA Vantage is similar to the DCA 2000+ in both Technological Characteristics and Intended Use. The data presented is a summary of risk management activities, internal performance testing and software development documentation. The information presented in this Special 510(k) provides confirmation that the DCA Vantage™ is substantially equivalent to the currently marketed DCA 2000+.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 9 2007

Siemens Medical Solutions Diagnostics Point of Care (POC) Products c/o Noor Malki Manager, Regulatory Affairs & Compliance 2 Edgewater Drive Norwood, MA 02062

k071466 Re:

> Trade/Device Name: DCA Vantage™, Model 5075 Regulation Number: 21 CFR§864.7470 Regulation Name: Glycosylated Homoglobin Assay Regulatory Class: Class II Product Code: LCP, JIR, CGX Dated: September 5, 2007 Received: September 6, 2007

Dear Noor Malki:

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).

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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 [phone]. 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/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

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# Indications for Use

510(k) Number (if known): K071466

Device Name: DCA Vantage™

Indications For Use:

The DCA Vantage™ is a semi-automated, benchtop system. It is designed to quantitatively measure the percent Hemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine.

The measurement of hemoglobin A1c concentration is recommended for monitoring the longterm glycemic control of persons with diabetes.

Testing for microalbuminuria (low concentration of albumin in urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). It is intended for use in both screening for, and monitoring treatment of, microalbuminuria.

Measurement of creatinine is used as a calculation basis to adjust the albumin/creatinine ratio result for varying urine concentrations.

The reporting of albumin/creatinine ratio is recommended for the early detection of kidney diseases.

The DCA Vantage system is for use in laboratories such as: physician office laboratories, clinics, and hospitals.

Tests performed using the DCA Vantage™ are intended for in vitro diagnostic use.

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 (OIVD)

Carol C. Benson
on Sign-Off

്വീce of In Vitro Diagnostic Device . aluation and Safety

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