← Product Code [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC) · K061792 # DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI (K061792) _Dade Behring, Inc. · DIC · Jul 18, 2006 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K061792 ## Device Facts - **Applicant:** Dade Behring, Inc. - **Product Code:** [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC.md) - **Decision Date:** Jul 18, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 862.3040 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use Alcohol (Ethyl) The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning. Alkaline Phosphatase The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System. Calcium The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System. ## Device Story Repackaged reagent cartridges for Dimension Vista Integrated System; modification involves reduction in sample and reagent volumes while maintaining original ratio; enables increased test capacity per pack; intended for clinical laboratory use; provides quantitative analysis of Ethyl Alcohol, Alkaline Phosphatase, Calcium, Lactic Acid, and Lithium. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on the identical chemical formulation and assay technology compared to previously cleared predicate devices. ## Technological Characteristics Reagent cartridges for automated clinical chemistry analysis. Modification involves volume reduction of reagents and samples; maintains original ratio. Operates on Dimension Vista Integrated System. No change to fundamental scientific technology or detection methods. ## Regulatory Identification An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. ## Predicate Devices - Dimension® ALC Flex® reagent cartridge ([K904302](/device/K904302.md)) - Dimension® ALP Flex® reagent cartridge ([K860021](/device/K860021.md)) - Dimension® CA Flex® reagent cartridge ([K860021](/device/K860021.md)) - Dimension® LA Flex® reagent cartridge ([K914508](/device/K914508.md)) - Dimension® LI Flex® reagent cartridge ([K011033](/device/K011033.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER k061792 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable: 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. k904302 – Dimension Ethyl Alcohol Flex reagent cartridge k860021 – Dimension Alkaline Phosphatase Flex reagent cartridge k860021 - Dimension Calcium Flex reagent cartridge k914508 - Dimension Lactic Acid Flex reagent cartridge k011033 – Dimension Lithium Flex reagent cartridge 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for repackaging existing reagents for use on Dimension Vista Integrated System. There is a reduction in sample volume and reagent volume but the final ratio is the same as the predicate device's ratio. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, sample type, analytes, detection methods and the number of tests per reagent pack. The Dimension Vista supports more tests per pack than the Dimension platform. This was accomplished by decreasing the reagent and sample volumes. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device. {1} 2 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K061792](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K061792) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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