510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase

K061020510(k) SpecialCleared May 10, 200627-day reviewClass I21 CFR 862.1030Recalls 1

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

Dade Behring, Inc. · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

Cleared on May 10, 2006 as substantially equivalent to K861700 (E.I. Dupont DE Nemours & Co., Inc., 1986) and 4 other predicates after a 27-day review. Its family tree reaches back 2 generations to 1986. It has been recalled once.

Decided
May 10, 2006
Review
27 days
Class
Class I
Product code
CKA
Recalls
1
Predicates
5

Its longest line of descent runs back 2 generations to K864230 (1986). 6 ancestors in all, the oldest K860021 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1986: 3 other ancestorsK864230 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986K994115 · Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge · Dade Behring, Inc. · 2000 · recalled19851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors K994115 · Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge · Dade Behring, Inc. · 2000 · recalledK864230 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 19860
  1. Root · 2 generations backK864230 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. 1 generation backK994115 Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc. · 2000 · Recalled
  3. This deviceK061020 Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino…Dade Behring, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K864230Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc.1986—
−1K994115Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc.20002
0 (this device)K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198630
199610
FIG. 1 — Lineage of K061020, 1986–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K861700Dimension (TM) Clinical Chemistry System
Summary page 1
…uct Predicate 510(k) # class tion Code Dimension VistaT M Dimension® ALB ALB Flex® reagent Flex® reagent K861700 11 862.1035 CJW cartridge cartridge Dimension VistaTM Dimension® AST AST Flex®reagent F…
E.I. Dupont DE Nemours & Co., Inc.19862
*K860021Dimension (TM) Clinical Chemistry System
Summary page 1
…reagent K861700 11 862.1035 CJW cartridge cartridge Dimension VistaTM Dimension® AST AST Flex®reagent Flex®reagent K860021 1I 862.1100 CIT cartridge cartridge Dimension VistaTM Dimension® CRBM Flex®…
E.I. Dupont DE Nemours & Co., Inc.19861
*K962820Carbamazepine Flex Reagent Cartridge
Summary page 2
…860021 1I 862.1100 CIT cartridge cartridge Dimension VistaTM Dimension® CRBM Flex® reagent CRBM Flex® K962820 11 862.3645 KLT cartridge reagent cartridge Dimension VistaTM Dimension® ALT ALT Flex® r…
Dade Intl., Inc.1996—
*K862359Meth./Cali./Intru. Check for the Dimension System
Summary page 2
…K962820 11 862.3645 KLT cartridge reagent cartridge Dimension VistaTM Dimension® ALT ALT Flex® reagent Flex® reagent K862359 1* 862.1030 CKA cartridge cartridge Dimension VistaTM Dimension® TIBC Flex® reagent…
E.I. Dupont DE Nemours & Co., Inc.19862
*K994115Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge
Summary page 2
…gent K862359 1* 862.1030 CKA cartridge cartridge Dimension VistaTM Dimension® TIBC Flex® reagent IBCT Flex® K994115 1 862.1415 IMO cartridge reagent cartridge * Not exempt when indications include diagnosis of…
Dade Behring, Inc.20002

Also cleared against K861700: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 29, 2017Class IIZ-1657-2018Device DesignVarious assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
  • 4 of the 6 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K861700.

How does its category compare?

All CKA devices

CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKA

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CKA

Too few CKA 510(k)s in any year since 2007 to give a median.

Recalls per year · CKA

1in 2016

2007: 82010: 12016: 1
2007high 8 (2007) · low 0 (2008)2026

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

Adverse event reports per year · CKA

8in 2025

2010: 82011: 392012: 82017: 22018: 12020: 32021: 22022: 22023: 42024: 102025: 8
2007high 39 (2011) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—80
20080—00
20090—00
20100—18
20110—039
20121—08
20131—00
20140—00
20150—00
20160—10
20170—02
20180—01
20190—00
20200—03
20210—02
20220—02
20230—04
20240—010
20250—08
20260—0—

What is it indicated for?

The Dimension VistaTM Albumin Flex® reagent cartridge (ALB) is a device intended to mreasure the albumin concentration in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The Dimension VistaTM Aspartate amino transferase (AST) Flex® reagent cartridge is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in…

Read the full statement (231 words)

The Dimension VistaTM Albumin Flex® reagent cartridge (ALB) is a device intended to mreasure the albumin concentration in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Dimension VistaTM Aspartate amino transferase (AST) Flex® reagent cartridge is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

The Dimension VistaTM Carbamazepine (CRBM) Flex® reagent cartridge is a device intended to measure carbamazepine, an anticonvulsant drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

The Dimension VistaTM Alanine amino transferase (ALT) Flex® reagent cartridge is intended to measure the activity of the enzyme pyruvic transaminase (ALT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

The Dimension VistaTM Total Iron-binding capacity (TIBC) Flex® reagent cartridge is intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Indications for use as stated in the FDA summary.

Also cleared against K861700

5 other devices cite the same predicate.

  • K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc. · 2017
  • K061719Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator; Models K1167, KC212Dade Behring, Inc. · 20062 recalls
  • K061702Dimension Vista System Creatine Kinase Calibrator (CK Cal - KC340)Dade Behring, Inc. · 2006
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 20067 recalls
  • K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc. · 20061 recall

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in CKA

The CKA category page

  • K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge AstHitachi Chemical Diagnostics, Inc. · 2013
  • K113382Ace Alt ReagentAlfa Wassermann · 20121 recall
  • K020487Careside AltCareside, Inc. · 2002
  • K980028Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)Trace America, Inc. · 1998
  • K973869Trace Reagent Line for the Cobas MiraTrace America, Inc. · 1998

https://510kreport.com/device/K061020 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061020: Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061020

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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