510(k) · Cleared
Recalled · Class II · 2017Dimension Vista Flex Reagent Cartridges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LDP Colorimetry, Acetaminophen
Cleared on Jul 10, 2006 as substantially equivalent to K963244 (Dade Intl., Inc., 1996) and 15 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1989. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Jul 10, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- LDP
- Recalls
- 7
- Predicates
- 16
Its longest line of descent runs back 4 generations to K891093 (1989). 23 ancestors in all, the oldest K833384 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK891093 Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1989
- 3 generations backK990255 Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999
- 2 generations backK032574 Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003
- 1 generation backK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
- This deviceK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891093 | Aca (R) Digitoxin Calibrator | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| −3 | K990255 | Dimension Drug Calibrator II, Model DC49B | Dade Behring, Inc. | 1999 | — |
| −2 | K032574 | Dimension Drug Calibrator II, Model DC49C | Dade Behring, Inc. | 2003 | — |
| −1 | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug… | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K061655 | Dimension Vista Flex Reagent Cartridges | Dade Behring, Inc. | 2006 | — |
| +1 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium… | Siemens Healthcare Diagnostics | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 1986 | 3 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 LDP? 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 LDP device
- #1 K261364 Atellica CH Acetaminophen 2 (ACTM)score 11.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (16)
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 | Decided |
|---|---|---|---|
| * | K963244 | Acetaminophen Flex Reagent CartridgeSummary page 2…oduct New Product Predicate Class Regulation Code Dimension VistaTM Dimension® ACTM ACTM Flex® Flex® reagent K963244 11 862.3030 LDP reagent cartridge cartridge Dimension VistaTM Dimension® AMY AMY Flex® Flex® re… | 1996 |
| * | K942640 | Dupont Dimension Amylase MethodSummary page 2…reagent K963244 11 862.3030 LDP reagent cartridge cartridge Dimension VistaTM Dimension® AMY AMY Flex® Flex® reagent K942640 II 862.1070 JFJ reagent cartridge cartridge Dimension VistaTM Dimension® CK CK Flex® reagent Flex® rea… | 1994 |
| * | K941584 | Creatine Kinase MethodSummary page 2…® reagent K942640 II 862.1070 JFJ reagent cartridge cartridge Dimension VistaTM Dimension® CK CK Flex® reagent Flex® reagent K941584 11 862.1215 JHS cartridge cartridge Dimension VistaTM Dimension® CHOL CHOL Flex® Flex® r… | 1994 |
| * | K861700 | Dimension (TM) Clinical Chemistry SystemSummary page 2…reagent K941584 11 862.1215 JHS cartridge cartridge Dimension VistaTM Dimension® CHOL CHOL Flex® Flex® reagent K861700 1' 862.1175 CHH reagent cartridge cartridge Dimension VistaTM Dimension® GGT GGT Flex® Flex®reag… | 1986 |
| * | K031135 | Glucose Flex Reagent Cartridge (Gluc)Summary page 2…eagent K861700 1* 862.1360 JQB reagent cartridge cartridge Dimension VistaTM Dimension® GLUC GLU Flex Flexe®reagent K031135 11 862.1345 CFR reagent cartridge cartridge Dimension VistaTM Dimension® AHDL HDLCFlex® Flex®rea… | 2003 |
| * | K053157 | Automated HDL Cholesterol Flex Reagent Cartridge, Model DF48ASummary page 2…®reagent K031135 11 862.1345 CFR reagent cartridge cartridge Dimension VistaTM Dimension® AHDL HDLCFlex® Flex®reagent K053157 1* 862.1475 LBS reagent cartridge cartridge Dimension VistaTM Dimension® ALDL LDLC Flex® Flex® re… | 2005 |
| * | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Summary page 2…reagent K053157 1* 862.1475 LBS reagent cartridge cartridge Dimension VistaTM Dimension® ALDL LDLC Flex® Flex® reagent K020724 862.1475 MRR reagent cartridge cartridge… | 2002 |
| * | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Summary page 3…510(k) class Code Dimension VistaTM Dimension® LIDO LIDO Flex® Flex® reagent K033809 11 862.3555 KLR reagent cartridge cartridge Dimension VistaTM Dimension® MG MG Flex® reagent… | 2004 |
| * | K950180 | Dupont Dimension (R) Pseudocholinesterase MethodSummary page 3…K861700 1' 862.1495 JGJ cartridge cartridge Dimension VistaTM Dimension® PCHE PCHE Flex® Flex® reagent K950180 1* 862.3240 DIH reagent cartridge cartridge Dimension VistaTM Dimension® PHOS PHOS Flex®… | 1995 |
| * | K032573 | Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110Summary page 3…K861700 1* 862.1580 CEO reagent cartridge cartridge Dimension VistaTM Dimension® PROC PROC Flex® Flex® reagent K032573 II 862.3320 LAR reagent cartridge cartridge Dimension VistaTM Dimension® SAL SAL Flex® reagent… | 2003 |
| * | K904301 | DU Pont Dimension (R) Salicylate (Sal) MethodSummary page 3…K032573 II 862.3320 LAR reagent cartridge cartridge Dimension VistaTM Dimension® SAL SAL Flex® reagent Flex® reagent K904301 11 862.3830 DKJ cartridge cartridge Dimension VistaTM Dimension® T4 T4 Flex® reagent… | 1990 |
| * | K862359 | Meth./Cali./Intru. Check for the Dimension SystemSummary page 3…K904301 11 862.3830 DKJ cartridge cartridge Dimension VistaTM Dimension® T4 T4 Flex® reagent Flex® reagent K862359 11 862.1700 KLI cartridge cartridge Dimension VistaTM Dimension® TOBRA TOBR Flex®… | 1986 |
| * | K962818 | Tobramycin Flex Reagent CartridgeSummary page 3…K862359 11 862.1700 KLI cartridge cartridge Dimension VistaTM Dimension® TOBRA TOBR Flex® Flex® reagent K962818 11 862.3900 LCR reagent cartridge cartridge Dimension VistaTM Dimension® TGL TRIG Flex®… | 1996 |
| * | K010871 | TGL Flex Reagent CartridgeSummary page 3…K962818 11 862.3900 LCR reagent cartridge cartridge Dimension VistaTM Dimension® TGL TRIG Flex® Flex® reagent K010871 1* 862.1705 CDT reagent cartridge cartridge Dimension VistaTM Dimension® URCA URCA Flex®… | 2001 |
| * | K982880 | Dimension (R) Valproic (Valp) Acid MethodSummary page 3…K862359 1* 862.1775 KNK reagent cartridge cartridge Dimension VistaTM Dimension® VALP VALP Flex® Flex® reagent K982880 II 862.3645 LEG reagent cartridge cartridge Dimension VistaTM Dimension® VANC VANC Flex®… | 1998 |
| * | K963267 | Vancomycin Flex Reagent CartridgeSummary page 3…K982880 II 862.3645 LEG reagent cartridge cartridge Dimension VistaTM Dimension® VANC VANC Flex® Flex® reagent K963267 II 862.3950 LEH reagent cartridge cartridge * Not exempt from premarket notification per 862.9 or pe… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-1658-2018 | Device Design | Various 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. |
| Jun 29, 2017 | Class II | Z-1660-2018 | Device Design | Various 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. |
| Mar 17, 2016 | Class II | Z-1665-2016 | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples… |
| Mar 17, 2016 | Class II | Z-1666-2016 | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples… |
| Sep 30, 2015 | Class II | Z-0339-2016 | Nonconforming Material/Component | Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6… |
| Jul 17, 2012 | Class III | Z-2175-2012 | Nonconforming Material/Component | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System. |
| Feb 17, 2012 | Not classified | Z-1433-2012 | Nonconforming Material/Component | Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K140790 (Siemens Healthcare Diagnostics, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDP
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LDP
Too few LDP 510(k)s in any year since 2007 to give a median.
Recalls per year · LDP
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDP
3in 2025
MAUDE reports naming product code LDP, 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 | 0 | — | 1 | 6 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 2 | 5 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Dimension VistaTM Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose. The Dimension VistaTM Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase…
Read the full statement (925 words)
The Dimension VistaTM Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
The Dimension VistaTM Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
The Dimension VistaTM Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.
The Dimension VistaTM Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
The Dimension VistaTM Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
The Dimension VistaTM Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
The Dimension VistaTM High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Dimension VistaTM Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Dimension VistaTM Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.
The Dimension VistaTM Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The Dimension VistaTM Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
The Dimension VistaTM Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
The Dimension VistaTM Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.
The Dimension VistaTM Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
The Dimension VistaTM Thyroxine (T4) Flex®reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
The Dimension VistaTM Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
The Dimension VistaTM Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The Dimension VistaTM Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The Dimension VistaTM Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
The Dimension VistaTM Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061655: Dimension Vista Flex Reagent Cartridges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061655
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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