(77 days)
Not Found
No
The summary describes a standard in-vitro diagnostic test using enzymatic reactions and does not mention any AI or ML components.
No
Explanation: This device is described as an "in-vitro diagnostic test" for measuring ethyl alcohol in human samples, which is used for diagnosis and treatment of alcohol intoxication. It is not used to directly treat a medical condition.
Yes.
The "Intended Use / Indications for Use" states that the test results "may be used in the diagnosis and treatment of alcohol intoxication and poisoning." This directly indicates a diagnostic purpose.
No
The device description clearly states it is a "reagent cartridge" containing chemical reagents, which are physical components, not software. It is an in-vitro diagnostic test kit used on a specific hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine." It also mentions its use in the "diagnosis and treatment of alcohol intoxication and poisoning." This clearly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description refers to it as a "prepackaged in-vitro diagnostic test method."
- Predicate Devices: The listed predicate devices (K904302 and K010960) are also IVD devices, indicating that this device falls within the same regulatory category.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
Product codes (comma separated list FDA assigned to the subject device)
DIC Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method
Device Description
The Dimension Vista® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension Vista® System. The reagents contained in the Dimension Vista® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.
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)
Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Dimension® ALC Flex® reagent cartridge (K904302), Syva® Emit® II Plus Ethyl Alcohol Assay (K010960)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 1 3 2007
. . . . . . . . . . . . . .
510(k) Summary of Safety and Effectiveness for the Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (K5022)
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.
A. 510(k) Number: KO70853
B. Date of Preparation: March 26, 2007
C. Proprietary and Established Names:
Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (K5022)
- D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862.3040 Clinical toxicology test system
-
- Classification: Class II
-
- Product Code: DIC Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method
4. Panel: Toxicology
G. Predicate Device:
The Dimension Vista® ETOH Flex® reagent cartridge is substantially equivalent to the Dimension® ALC Flex® reagent cartridge (K904302) and to the Syva® Emit® II Plus Ethyl Alcohol Assay (K010960).
H. Device Description:
The Dimension Vista® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension Vista® System. The reagents contained in the Dimension Vista® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.
1
- G. Intended Use: The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine, Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
I. Substantial Equivalence Information:
The Dimension Vista® ETOH Flex® reagent cartridge and the predicates, Dimension® ALC Flex® reagent cartridge and Syva® Emit® II Plus Ethyl Alcohol Assay, were compared. A comparison of the important similarities and differences between the device and the predicates is provided in the following table:
| Feature | Dimension Vista®
ETOH Flex®
reagent cartridge | Dimension® ALC
Flex® reagent
cartridge
(K904302) | Syva® Emit® II Plus
Ethyl Alcohol Assay
(K010960)* |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Dimension Vista®
ETOH Flex® reagent
cartridge is an in-vitro
diagnostic test for the
quantitative measurement
of ethyl alcohol in human
serum, plasma, and urine.
Ethyl alcohol test results
may be used in the
diagnosis and treatment of
alcohol intoxication and
poisoning. | The ALC method used in the
Dimension® clinical
chemistry system is an in
vitro diagnostic test intended
to measure ethyl alcohol in
human serum and
supernatants from
precipitated whole blood and
to qualitatively detect ethyl
alcohol in urine. | The EMIT® II Plus Ethyl
Alcohol Assay is intended
for use in the quantitative
analysis of ethyl alcohol
(ethanol) in human urine,
serum, or plasma. |
| Sample Type | Plasma, serum, and urine. | Serum, supernatants from
precipitated whole blood and
urine. | Plasma, serum, and urine. |
| Measuring
Range | 3 -300 mg/dL | 0 - 300 mg/dL | 10-600 mg/dL |
| Sample Size | 4 µL | 3 µL | 4 µL |
| Measurement | Bichromatic rate | Bichromatic endpoint | Bichromatic rate |
| Principle | The ETOH method is
based on an enzymatic
reaction. | The ethyl alcohol (ALC)
method is a modification of
the alcohol dehydrogenase
(ADH) enzymatic procedure. | The Emit®II Plus Ethyl
Alcohol Assay is based on
an enzymatic reaction. |
*Tested on the Roche/Hitachi 717 Analyzer.
J. Conclusion:
The Dimension Vista® ETOH Flex® reagent cartridge is substantially equivalent to the Dimension® ALC Flex® reagent cartridge (K904302) and to the Syva® Emit® II Plus Ethyl Alcohol Assay (K010960). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. Glasgow Business Community c/o Mr. Victor Carrio RA/QS Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714-6101
JUN 1 3 2007
Re: K070853
Trade/Device Name: Dimension Vista ETOH Flex Reagent Cartridge, Model K5022 Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system. Regulatory Class: Class II Product Code: DIC Dated: March 26, 2007 Received: March 28, 2007
Dear Mr. Carrio:
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 Amendmonts, 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 11 The general controls provisions of the Act include requirements for annual registiation, into 1.0.7 devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nound 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 Degiter.
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 protice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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) 276-0490. 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 tolli ine (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
510(k) Number (if known): K070853
Device Name:
Dimension Vista® ETOH Flex® Reagent Cartridge (K5022)
Indications for Use:
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
Prescription Use な (Per 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
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