510(k) Report

510(k) · Cleared

Cleared

Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)

K062034510(k) TraditionalCleared Sep 6, 200649-day reviewClass II21 CFR 862.1150

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

Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Sep 6, 2006 as substantially equivalent to K011035 (Dade Behring, Inc., 2001) after a 49-day review. Its family tree reaches back 1 generation to 2001.

Decided
Sep 6, 2006
Review
49 days
Class
Class II
Product code
JIX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011035 (2001). No later device cites it as a predicate yet.

K011035 · Dimension Drug Calibrator, Model DC22B · Dade Behring, Inc. · 200120002002200420062008
K011035 · Dimension Drug Calibrator, Model DC22B · Dade Behring, Inc. · 20010
  1. Root · 1 generation backK011035 Dimension Drug Calibrator, Model DC22BDade Behring, Inc. · 2001
  2. This deviceK062034 Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)Dade Behring, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011035Dimension Drug Calibrator, Model DC22BDade Behring, Inc.2001—
0 (this device)K062034Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)Dade Behring, Inc.2006—
FIG. 1 — Lineage of K062034, 2001–2006Source: 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 JIX? 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? (1)

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
*K011035Dimension Drug Calibrator, Model DC22B
Summary page 2
…Dimension VistaTM System Drug Dimension® Drug Calibrator 1 Calibrator' (K011035) Intended The DRUG I CAL isan in vitro The Drug Calibrator is an in vitro Use diag…
Dade Behring, Inc.2001—

Also cleared against K011035: 4 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 4 other devices also cite its predicate K011035.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

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

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

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

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

What is it indicated for?

The DRUG I CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista TM System.

Indications for use as stated in the FDA summary.

Also cleared against K011035

4 other devices cite the same predicate.

  • K112142Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics · 20111 recall
  • K093441Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435Siemens Healthcare Diagnostics · 20102 recalls
  • K093732Advia Chemistry Drug Calibrator I Model 10376770Siemens Healthcare Diagnostics · 20101 recall
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 200532 recalls

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 JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014

https://510kreport.com/device/K062034 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062034: Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062034

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