510(k) Report

510(k) · Cleared

Cleared

Dimension Vista Ammonia (Amon) Flex Reagent Cartridge

K062316510(k) SpecialCleared Sep 6, 200628-day reviewClass I21 CFR 862.1065

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

Dade Behring, Inc. · JIF Enzymatic Method, Ammonia

Cleared on Sep 6, 2006 as substantially equivalent to K863840 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 28-day review. Its family tree reaches back 1 generation to 1986.

Decided
Sep 6, 2006
Review
28 days
Class
Class I
Product code
JIF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K863840 (1986). No later device cites it as a predicate yet.

K863840 · Meth. & Cali. for the Dimension Clini/Chem. System · E.I. Dupont DE Nemours & Co., Inc. · 198619851990199520002005
K863840 · Meth. & Cali. for the Dimension Clini/Chem. System · E.I. Dupont DE Nemours & Co., Inc. · 19860
  1. Root · 1 generation backK863840 Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. This deviceK062316 Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863840Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc.1986—
0 (this device)K062316Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc.2006—
FIG. 1 — Lineage of K062316, 1986–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K863840Meth. & Cali. for the Dimension Clini/Chem. System
Summary page 1
…n/Usual Name: 862.1065 Enzymatic Method, Ammonia Ammonia test system Product code: JIF Predicate Device: Dimension® Ammonia (AMON) Flex® reagent cartridge (K863840) Device Description: Dade Behring Dimension VistaTM Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (a…
E.I. Dupont DE Nemours & Co., Inc.1986—

Also cleared against K863840: 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 K863840.

How does its category compare?

All JIF devices

JIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIF

1in 2019

2013: 22019: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIF

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

Recalls per year · JIF

1in 2015

2007: 12009: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · JIF

5in 2025

2009: 12010: 32011: 72013: 22014: 12015: 32016: 42017: 72018: 12019: 12020: 12021: 12022: 22023: 42024: 12025: 5
2007high 7 (2011) · low 0 (2007)2025

MAUDE reports naming product code JIF, 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—10
20080—00
20090—11
20100—03
20110—07
20120—00
20132—02
20140—01
20150—13
20160—04
20170—07
20180—01
20191—01
20200—01
20210—01
20220—02
20230—04
20240—01
20250—05
20260—0—

What is it indicated for?

The Dimension VistaTM Ammonia (AMON) Flex® reagent cartridge is an in vitro device intended to measure ammonia levels in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Indications for use as stated in the FDA summary.

Also cleared against K863840

4 other devices cite the same predicate.

  • K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)Siemens Healthcare Diagnostics · 20131 recall
  • K123320Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics · 20133 recalls
  • K062152Creatinine Kinase MB Isoenzyme Verifier, Model DC27Dade Behring, Inc. · 2006
  • K994114Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc. · 2000

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 JIF

The JIF category page

  • K183517Ammonia IIRoche Diagnostics Operations (Rdo) · 2019
  • K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)Siemens Healthcare Diagnostics · 20131 recall
  • K123320Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics · 20133 recalls
  • K051114Sentinel Ammonia Ultra Diagnostic AssaySentinel Ch. Srl · 20051 recall
  • K033921Ammonia-L3K Assay, Catalogue Number 233-10Diagnostic Chemicals, Ltd. · 20041 recall

https://510kreport.com/device/K062316 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062316: Dimension Vista Ammonia (Amon) Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062316

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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