(69 days)
Not Found
No
The summary describes a standard enzyme assay for quantitative analysis of ethyl alcohol. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional analytical chemistry metrics like correlation, precision, specificity, and sensitivity.
No
The device is an enzyme assay intended for the quantitative analysis of ethyl alcohol in human biological samples (serum, plasma, urine), which is a diagnostic function, not a therapeutic one.
Yes
The device is described as an "enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human serum, plasma, or urine," which indicates it is used to measure a substance in a biological sample to provide information for diagnosis or monitoring.
No
The device is described as an "enzyme assay" and the performance studies detail chemical reactions and measurements, indicating it is a laboratory test kit with physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative analysis of ethyl alcohol in human serum or plasma" and "human urine, plasma, and serum." This indicates it's used to test samples taken from the human body.
- Device Description: The description reinforces this by stating it's for "quantitative analysis of ethyl alcohol in human urine, serum, or plasma."
- Sample Types: The device analyzes human biological samples (serum, plasma, urine).
- Purpose: The purpose is to provide quantitative information about the presence and amount of ethyl alcohol in these samples, which is used for diagnostic or monitoring purposes.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative rne Emit - 11 Tub any) Aconol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.
Product codes
DML
Device Description
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990. Syva Company - Dade Behring Inc. is submitting the Premarket Notification, 510(k) with the intention to commercially market an in vitro diagnostic reagent test kit for the analysis of ethyl alcohol in human urine, serum, or plasma. The Syva Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in quantitative analysis of ethyl alcohol in human urine, serum, or plasma. The Syva Emit® II Plus Ethyl Alcohol Assay has been found to be equivalent to the predicate device: Emit® Ethyl Alcohol Assay (K903153) with regard to intended use, assay sample, and overall performance characteristics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Comparative Analysis: The Syva Emit® II Plus Ethyl Alcohol Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a correlation of 0.986 with serum and 0.997 with urine, with a slope value of 1.000 with both urine and serum.
Precision: A Precision study was performed and the Syva Emit® II Plus Ethyl Alcohol Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 1.39% to 1.55% and acceptable total precision with coefficients of variation (%CV) ranging from 1.61% to 1.78%.
Specificity: A study was performed on potentially cross-reacting compounds and the Syva Emit® II Plus Ethyl Alcohol Assay demonstrated acceptable levels of cross-reactivity, ranging from
§ 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 Emit® Ethyl Alcohol Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company |
|---|---|
| 3403 Yerba Buena Rd. | |
| P.O. Box 49013 | |
| San Jose, CA 95161-9013 |
Paul Rogers Contact Information: Syva Company - Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: 408-239-2000
2. Device Classification Name:
The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Ethyl Alcohol System" as Class II.
3. Intended Use:
Emit® II Plus Ethyl Alcohol Assay is an enzyme assay. The assay is intended for use in the quantitative analysis of ethyl alcohol in human serum or plasma.
4. Device Description and Characteristics:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
Syva Company - Dade Behring Inc. is submitting the Premarket Notification, 510(k) with the intention to commercially market an in vitro diagnostic reagent test kit for the analysis of ethyl alcohol in human urine, serum, or plasma.
The Syva Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in quantitative analysis of ethyl alcohol in human urine, serum, or plasma. The Syva Emit® II Plus Ethyl Alcohol Assay has been found to be equivalent to the predicate device: Emit® Ethyl Alcohol Assay (K903153) with regard to intended use, assay sample, and overall performance characteristics.
Comparative Analysis: The Syva Emit® II Plus Ethyl Alcohol Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a correlation of 0.986 with serum and 0.997 with urine, with a slope value of 1.000 with both urine and serum.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® Ethyl Alcohol Assay (cont.)
Precision: A Precision study was performed and the Syva Emit® II Plus Ethyl Alcohol Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 1.39% to 1.55% and acceptable total precision with coefficients of variation (%CV) ranging from 1.61% to 1.78%.
Specificity: A study was performed on potentially cross-reacting compounds and the Syva Emit® II Plus Ethyl Alcohol Assay demonstrated acceptable levels of cross-reactivity, ranging from Trade Name: Emit® II Plus Ethyl Alcohol Assay Regulatory Class: II Product Code: DML Dated: November 23, 1999 Received: November 24, 1999
Dear Mr. Rogers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known):
Emit® II Plus Ethyl Alcohol Assay Device Name:
Indications for Use:
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative rne Emit - 11 Tub any) Aconol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Device Name: Emit® II Plus Ethyl Alcohol Assay
Patricia Bernhardt for S.D.C.
Division of Clinical Laboratory Devices 510(k) Number.
く.