(133 days)
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.
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.
Here's an analysis of the provided text regarding the DCA Vantage device, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
The provided document describes a Special 510(k) submission for the DCA Vantage, a device modification of the DCA 2000+. The primary goal of the study was to demonstrate substantial equivalence to the predicate device (DCA 2000+), not necessarily to predefined "acceptance criteria" in the sense of absolute performance thresholds against a gold standard. Instead, the acceptance criteria are implicitly met if the DCA Vantage performs comparably to the DCA 2000+.
The study aimed to show that the DCA Vantage meets accuracy and precision requirements relative to the DCA 2000+.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Relative to DCA 2000+) | Reported Device Performance (DCA Vantage vs. DCA 2000+) |
|---|---|---|
| Accuracy | DCA Vantage results for HbA1c, Albumin, Creatinine, and Albumin/Creatinine ratio should meet accuracy requirements using Linear Regression relative to the DCA 2000+ using clinical specimens. | "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." |
| Precision | DCA Vantage results for HbA1c, Albumin, and Creatinine should meet precision performance requirements relative to the DCA 2000+ using quality controls. | "the DCA Vantage meets the precision performance requirements for HbA1c, Albumin, and Creatinine relative to the DCA 2000+ using quality controls." |
Note: The document does not provide specific numerical ranges or statistical thresholds for "accuracy requirements" or "precision performance requirements." It states that these requirements were "met," implying that the statistical analysis (Linear Regression) confirmed a comparable performance to the predicate device.
Study Details:
-
Sample Size used for the test set and the data provenance:
- Sample Size:
- Fifty (50) whole blood specimens for HbA1c.
- Fifty (50) urine specimens for microalbumin/creatinine.
- Data Provenance: The study was an "internal study," suggesting it was conducted by the manufacturer (Siemens Medical Solutions Diagnostics). The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a device modification, it's likely prospective clinical samples collected for this specific validation, but this is not explicitly stated.
- Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The ground truth for this study was established using the predicate device (DCA 2000+) itself, not human expert consensus. The study aimed to show equivalence to an existing, legally marketed device.
-
Adjudication method for the test set:
- Not Applicable. Since the predicate device served as the reference for comparison, there was no need for expert adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an MRMC study. The device is a "semi-automated, benchtop analyzer" for quantitative measurements, not an imaging device that requires human interpretation or AI assistance for image analysis.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes. This was a standalone performance evaluation of the DCA Vantage device. While it is a "semi-automated" system requiring user interaction for sample introduction, its core function is independent measurement and reporting, not human-in-the-loop assistance for interpretation. The study directly compared the measurements produced by the DCA Vantage to those from the DCA 2000+.
-
The type of ground truth used:
- The "ground truth" or reference standard in this equivalence study was the DCA 2000+ Analyzer. The performance of the modified device (DCA Vantage) was compared against the measurements obtained from the predicate device (DCA 2000+) using the same clinical specimens and quality controls.
-
The sample size for the training set:
- Not Applicable / Not Specified. This device is a spectrophotometer that analyzes physical properties; it is not based on machine learning or AI that requires a "training set" in the traditional sense. The device's operation is based on established analytical principles and pre-programmed algorithms.
-
How the ground truth for the training set was established:
- Not Applicable. As noted above, there is no "training set" for this type of device mentioned in the documentation.
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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 MalkiManager, Regulatory Affairs & Compliance | OCT - 9 2007 |
| Address: | Siemens Medical Solutions DiagnosticsPoint of Care (POC) Products2 Edgewater DriveNorwood, 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 DeviceElement | Predicate (unmodified device) |
|---|---|
| Device Name | DCA 2000+ Analyzer |
| Classification NameandTitle 21 CFR | Glycosylated Homoglobin Assay $\checkmark$ (864.7470)Urinary Protein or Albumin Test System $\checkmark$ (862.1645)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 DevicesClinical Chemistry & Clinical Toxicology |
| CLIA Complexity | DCA 2000+ Glycosylated Hemoglobin Assay - WaivedDCA 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 (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/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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§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).