# K071466: Dca Vantage, Model 5075

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Oct 9, 2007 after 133 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951361 (1995). 2 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951361: Dca 2000 System for Hemoglobin A1C, Heraeus Kulzer, Inc. (1995) Summary page 1.
- K963142: Dca 2000 + Microalbumin/Creatinine Assay, Bayer Corp. (1996) Summary page 1.

## Most influential descendants
- K082275: Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023 (2010), 2 descendants of its own
- K130014: A1C Gear System (2014), 1 descendant of its own
- K121366: Hemocue HBA1C 501 (2012), 1 descendant of its own
- K163633: cobas HbA1c Test, cobas b 101 system (2017), 0 descendants of its own
- K142664: URight Hemoglobin A1c system, FORA A1c System (2016), 0 descendants of its own

## Recalls of this device
- Jun 30, 2020 · Class II · Z-2747-2020: If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configur

## Indications for use
The DCA VantageTM is a semi-automated, benchtop system. It is designed to quantitatively measure the percent Hemoglobin Alc in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The measurement of hemoglobin Alc concentration is recommended for monitoring the long- term 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 TM are intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K071466
Methodology: https://510kreport.com/methodology