510(k) · Cleared

Recalled · Class II · 2020

Dca Vantage, Model 5075

K071466510(k) SpecialCleared Oct 9, 2007133-day reviewClass II21 CFR 864.7470Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions Diagnostics · LCP Assay, Glycosylated Hemoglobin

Cleared on Oct 9, 2007 as substantially equivalent to K951361 (Heraeus Kulzer, Inc., 1995) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it. It has been recalled once.

Decided: Oct 9, 2007
Review: 133 days
Class: Class II
Product code: LCP
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K951361 (1995). 2 ancestors in all. 8 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
This deviceK071466 Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics · 2007
Descendant · cites it directly · 2 of its ownK082275 Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor…Infopia Co, Ltd. · 2010
Descendant · cites it directly · 1 of its ownK130014 A1C Gear SystemSakae Corporation · 2014
Descendant · 2 generations on · 1 of its ownK121366 Hemocue HBA1C 501Infopia Co, Ltd. · 2012
Descendant · cites it directly · 0 of its ownK163633 cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations · 2017
Descendant · cites it directly · 0 of its ownK142664 URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009high 3 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all

K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd. · 2010 · cites it directly2descendants
K130014A1C Gear SystemSakae Corporation · 2014 · cites it directly1descendant
K121366Hemocue HBA1C 501Infopia Co, Ltd. · 2012 · 2 generations on1descendant
K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations · 2017 · cites it directly0descendants
K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951361	Dca 2000 System for Hemoglobin A1C	Heraeus Kulzer, Inc.	1995	1
0 (this device)	K071466	Dca Vantage, Model 5075	Siemens Medical Solutions Diagnostics	2007	—
+1	K082275	Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model…	Infopia Co, Ltd.	2010	—
+1	K130014	A1C Gear System	Sakae Corporation	2014	—
+2	K121366	Hemocue HBA1C 501	Infopia Co, Ltd.	2012	—
+1	K163633	cobas HbA1c Test, cobas b 101 system	Roche Diagnostics Operations	2017	—
+1	K142664	URight Hemoglobin A1c system, FORA A1c System	Taidoc Technology Corporation	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2012	1	0
2014	3	0
2016	1	0
2017	1	0

FIG. 1 — Lineage of K071466, 1995–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LCP device

#1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K951361	Dca 2000 System for Hemoglobin A1C Summary page 1 …645) Title 21 CFR Creatinine Test System (862.1225) 510(k) Numbers * DCA 2000 System for Hemoglobin Alc (K951361) - 1.C PI a DCA 2000+ Microalbumin / Creatinine Assay (…	Heraeus Kulzer, Inc.	1995	1
*	K963142	Dca 2000 + Microalbumin/Creatinine Assay Summary page 1 …2000 System for Hemoglobin Alc (K951361) - 1.C PI a DCA 2000+ Microalbumin / Creatinine Assay (K963142)) ) (!- Manufacturer Bayer HealthCare LLC (currently Siemens Medical S…	Bayer Corp.	1996	—

Also cleared against K951361: 4 other devices →

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082275	Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023	Infopia Co, Ltd.	2010	2
K130014	A1C Gear System	Sakae Corporation	2014	1
K163633	cobas HbA1c Test, cobas b 101 system	Roche Diagnostics Operations	2017	0
K142664	URight Hemoglobin A1c system, FORA A1c System	Taidoc Technology Corporation	2016	0
K091711	S- Test Hemoglobin Alc (HBA1C), Model RC0023	Alfa Wassermann Diagnostic Technologies, Inc.	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 30, 2020	Class II	Z-2747-2020	Labeling design	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 configured to run Code 39 with check digit and…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K082275 (Infopia Co, Ltd., 2010) has gone furthest, with 2 descendants of its own.
4 other devices also cite its predicate K951361.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LCP

1in 2024

2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007high 269 (2019) · low 127 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCP

1in 2025

2007high 51 (2011) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LCP

22in 2025

2007high 1,911 (2018) · low 4 (2010)2025

MAUDE reports naming product code LCP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	133	1	5
2008	5	206	3	11
2009	6	158	6	15
2010	2	—	5	4
2011	10	176	51	27
2012	9	143	0	51
2013	2	—	4	193
2014	8	127	2	182
2015	3	239	2	64
2016	2	—	6	29
2017	5	218	1	149
2018	2	—	1	1,911
2019	4	269	0	114
2020	1	—	0	13
2021	0	—	0	7
2022	0	—	1	8
2023	2	—	0	27
2024	1	—	1	39
2025	0	—	1	22
2026	0	—	0	—

What is it indicated for?

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…

Read the full statement (162 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071466: Dca Vantage, Model 5075.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071466

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026