(22 days)
K 051087
No
The document describes standard in-vitro diagnostic tests and a packaging modification for use on a different analyzer system. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The listed devices are in vitro diagnostic tests used for measurement of substances in body fluids to aid in diagnosis and treatment, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the methods described are "in vitro diagnostic test[s]" and that their results "may be used in the diagnosis and treatment" of various conditions.
No
The device description clearly states that the devices are "prepackaged in-vitro diagnostic test methods (assays)" and "reagent cartridges," which are physical components containing chemical reagents. These are hardware, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section explicitly states for each method (ALC, ALP, CA, LA, LI) that it is an "in vitro diagnostic test".
- Explicit Statement in Device Description: The "Device Description" section also states that the Dade Behring Dimension Vista™ Flex® reagent cartridges are "prepackaged in-vitro diagnostic test methods (assays)".
- Purpose of the Device: The device is designed to measure substances (ethyl alcohol, alkaline phosphatase, calcium, lactic acid, lithium) in human biological samples (serum, plasma, urine) to aid in the diagnosis and treatment of various medical conditions. This is the core function of an in vitro diagnostic device.
- Use with an IVD System: The device is designed to be used on the Dimension Vista™ Integrated system, which is described as a "fully automated, microprocessor-controlled, integrated instrument system" and is implied to be a clinical laboratory system used for diagnostic testing.
Therefore, based on the provided text, the device clearly falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
- Lactic Acid: The Dimension Vista™ 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).
- Lithium: The Dimension Vista™ 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).
Product codes
DIC, CJE, CJE, JIH, KHP
Device Description
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.
The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K904302, K860021, K914508, K011033
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3040 Alcohol test system.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Lorraine H Piestrak
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 | JUL 1 8 2006 |
|----------------------|------------------------------------------------------------------------------------|--------------|
| Date of Preparation: | June 23, 2006 | |
Name of Products:
Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge Dimension Vista™ Calcium (CA) Flex® reagent cartridge Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge
FDA Classification Name:
| Classification Name: | Common/Usual Name: |
|---|---|
| 862.3040 Alcohol Dehyrdogenase, specific reagent for | |
| Ethanol Enzyme method | Alcohol test system |
| 862.1050 Alkaline phosphatase | Alkaline phosphatase test system |
| 862.1145 Calcium | Calcium test system |
| 862.1450 Lactic acid | Lactic acid test system |
| 862.3560 Lithium | Lithium test system |
Predicate Device:
The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:
| New Product | Predicate | Predicate
510(k) # | Device
Class | Regulation | Product
Code |
|----------------------------------------------------|----------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™
ALC Flex® reagent
cartridge | Dimension® ALC
Flex® reagent cartridge | K904302 | II | 862.3040 | DIC |
| Dimension Vista™
ALP Flex® reagent
cartridge | Dimension® ALP
Flex® reagent
cartridge | K860021 | II | 862.1050 | CJE |
| Dimension Vista™
CA Flex® reagent
cartridge | Dimension® CA
Flex® reagent
cartridge | K860021 | II | 862.1145 | CIC |
1
| New Product | Predicate | Predicate
510(k) # | Device
Class | Regulation | Product
Code |
|---------------------------------------------------|---------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™
LA Flex® reagent
cartridge | Dimension® LA
Flex® reagent
cartridge | K914508 | I* | 862.1450 | KHP |
| Dimension Vista™
LI Flex® reagent
cartridge | Dimension® LI Flex®
reagent cartridge | K011033 | II | 862.3560 | JIH |
- Not exempt from premarket notification per 862.9 or per Reserved Medical Devices list
Device Description:
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.
The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.
Intended 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.
2
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101
JUL 1 8 2006
Re: K061792
Trade/Device Name: Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Dimension Vista™ Alkaline phoshatase (ALP) Flex® reagent cartridge Dimension Vista™ Calcium (CA) Flex® reagent cartridge Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge Regulation Number: 21 CFR§862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC, CJE, CJE, JIH, KHP Dated: June 23, 2006 Received: June 26, 2006
Dear Ms. Piestrak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K061792
Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Device Name:
Indications For Use:
The Dimension Vista™ 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of
Carol Benson
Division Sign-Off
310(k) K061792
5
510(k) Number (if known): K061792
Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge Device Name:
Indications For Use:
The Dimension Vista™ 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
512(K) K061792
6
510(k) Number (if known): K061792
Dimension Vista™ Calcium (CA) Flex® reagent cartridge Device Name:
Indications For Use:
The Dimension Vista™ 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).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-
7
Indications for Use 510(k) Number (if known): KOlo1792
Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Device Name:
Indications For Use:
The Dimension Vista™ 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).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benam
Division Sign-Off
) K061792
Page 4 of 5
8
510(k) Number (if known): K061792
Dimension Vista™ Lithium (LI) Flex® reagent cartridge Device Name:
Indications For Use:
The Dimension Vista™ 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).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benam
Division Sign-Off
Page 5 of 5