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

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.

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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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k071466

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k951361, k963142
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for 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 addition of a USB/Ethernet connection.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, reagents, test steps, and performance characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.