(52 days)
Not Found
No
The description focuses on a chemical assay and does not mention any AI or ML components.
No
The Intended Use / Indications for Use section states that it is an "in-vitro diagnostic test" used for "quantitative measurement of ethyl alcohol." Additionally, it says "test results may be used in the diagnosis and treatment," but the device itself does not perform the treatment. Therefore, it is a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The ETOH method is an in-vitro diagnostic test" and that "Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning."
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 method used on a clinical chemistry system, not a standalone software application.
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 measuring ethyl alcohol in human serum, plasma, and urine. It also mentions its use in the "diagnosis and treatment of alcohol intoxication and poisoning."
- Device Description: The description refers to the device as a "prepackaged in-vitro diagnostic test method."
- Predicate Devices: The listed predicate devices are also IVD tests (reagent cartridges for alcohol measurement).
All of these points clearly indicate that the device is intended for use outside of the body to examine specimens from the human body for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
Product codes
DIC
Device Description
The Dimension® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® 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)
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 for the Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22)
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: K071811
AUG 2 4 2007
B. Date of Preparation: June 29, 2007
C. Proprietary and Established Names:
Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22)
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
-
- Panel: Toxicology
G. Predicate Device:
The Dimension® 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® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® 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
- The ETOH method is an in-vitro diagnostic test for the quantitative G. Intended Use: measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. 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® ETOH
Flex® reagent
cartridge | Dimension® ALC
Flex® reagent
cartridge
(K904302) | Syva® Emit® II Plus
Ethyl Alcohol Assay
(K010960)* |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Dimension® ETOH
Flex® reagent cartridge is
an in-vitro diagnostic test
for the quantitative
measurement of ethyl
alcohol (ethanol) in human
serum, plasma, and urine
in the Dimension®
System. 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. Ethyl
alcohol test results may be
used in the diagnosis and
treatment of alcohol
intoxication and poisoning. | 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 | 9 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 SYVA30R Analyzer.
J. Conclusion:
The Dimension® 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services-PSA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-PSA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.
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
AUG 2 4 2007
Re: K071811
Trade/Device Name: Dimension Ethyl Alcohol (ETOH) Flex Reagent Cartridge (DF22) Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC Dated: July 2, 2007 Received: July 11, 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 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
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours.
Sincerely yours,
Carol Benson for
Jean M. Cooper, M.S., D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
4
Indications For Use Statement Konló। 510(k) Number (if known):
Device Name:
Dimension® ETOH Flex® Reagent Cartridge (DF22)
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 X (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)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
22(K) K071811