510(k) · Cleared
Recalled · Class II · 2018Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (LA) Flex Reagent Cartri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Jul 18, 2006 as substantially equivalent to K904302 (E.I. Dupont DE Nemours & Co., Inc., 1990) and 3 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1986. It has been recalled 2 times.
- Decided
- Jul 18, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- DIC
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K860021 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- This deviceK061792 Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp)…Dade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860021 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 1 |
| 0 (this device) | K061792 | Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0… | Dade Behring, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 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 DIC? 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 DIC device
- #1 K250609 Sober Self-Testscore 10.3 · 2 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K904302 | Dupont Dimension (R) Ethyl Alcohol (Alc) MethodSummary page 1…Product Predicate Class Regulation Code Dimension VistaTM Dimension® ALC ALC Flex® reagent Flex® reagent cartridge K904302 I1 862.3040 DIC cartridge Dimension VistaTM Dimension® ALP ALP Flex® reagent Flex® reagent… | 1990 |
| * | K860021 | Dimension (TM) Clinical Chemistry SystemSummary page 1…t Flex® reagent cartridge K904302 I1 862.3040 DIC cartridge Dimension VistaTM Dimension® ALP ALP Flex® reagent Flex® reagent K860021 II 862.1050 CJE cartridge cartridge Dimension VistaTM Dimension® CA CA Flex® reagent Flex®… | 1986 |
| * | K914508 | Dimension (R) Lactic Acid MethodSummary page 2…Product Predicate 510(k) # Regulation Dimension VistaTM Dimension® LA LA Flex® reagent Flex®reagent K914508 1* 862.1450 KHP cartridge cartridge Dimension Vista TM Dimension® LI Flex® LI Flex® reagen… | 1991 |
| * | K011033 | Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Summary page 2…14508 1* 862.1450 KHP cartridge cartridge Dimension Vista TM Dimension® LI Flex® LI Flex® reagent reagent cartridge K01 1033 1H 862.3560 JIH cartridge * Not exempt from premarket notification per 862.9 or per Reserved Medical Device… | 2001 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2018 | Class II | Z-1540-2018 | Under Investigation by firm | May produce erroneously low results from specific well sets. |
| Aug 3, 2016 | Class II | Z-0039-2017 | Under Investigation by firm | Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K904302.
How does its category compare?
All DIC devicesDIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DIC
Too few DIC 510(k)s in any year since 2007 to give a median.
Recalls per year · DIC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIC
3in 2025
MAUDE reports naming product code DIC, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension VistaTM Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. The Dimension VistaTM Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the…
Read the full statement (217 words)
The Dimension VistaTM Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension VistaTM Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
The Dimension VistaTM Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The Dimension Vista TM Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
The Dimension VistaTm Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061792: Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (LA) Flex Reagent Cartri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061792
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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