(69 days)
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human serum or plasma.
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.
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.
Here's a breakdown of the acceptance criteria and the study details for the Emit® II Plus Ethyl Alcohol Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Comparative Analysis | Excellent correlation (high correlation coefficient, slope near 1) to predicate device. | Serum: Correlation of 0.986 with predicate method, slope of 1.000. |
| Urine: Correlation of 0.997 with predicate method, slope of 1.000. | ||
| Precision | Acceptable within-run and total precision (low %CV). | Within-run: %CV ranging from 1.39% to 1.55%. |
| Total precision: %CV ranging from 1.61% to 1.78%. | ||
| Specificity | Acceptable levels of cross-reactivity (low percentage). | Cross-reactivity ranging from <0.1% to 14.2% for potentially cross-reacting compounds. |
| Sensitivity | Ability to distinguish low concentrations from zero. | Less than 3.0 mg/dL (lowest concentration of amphetamines that can be distinguished from 0 ng/mL with 95% confidence – Note: The text explicitly mentions "amphetamines" here, which seems like a typo given the Ethyl Alcohol assay. Assuming it means ethyl alcohol, the principle holds.) |
| Endogenous Interference | High recovery compared to controls (minimal interference). | Serum: Bilirubin: 99% recovery, Hemoglobin: 100% recovery, Triglycerides: 97% recovery. LDH/Lactate: 0.4 mg/dL interference (not significant). |
| Urine: Recoveries for interfering substances ranging from 99% to 104%. | ||
| Spiked Sample Recovery | Recovery within an acceptable range (e.g., 90-110%). | Recovery of ethanol spikes in human serum and urine ranged between 95.7% and 101.5% across a quantitative range of 10 to 600 mg/dL. |
| High Sample Dilution | Recovery within an acceptable range after dilution. | Recovery from normal concentrations in diluted serum and urine (with water or Negative Calibrator) ranged from 97.1% to 100.9%. |
| Anticoagulants | Average recovery compared to serum control within an acceptable range. | Average recovery versus serum control ranged from 95.5% to 102.3% for EDTA (K3), Sodium Citrate, Sodium Heparin, and Oxalate/Fluoride. |
| Linearity | Considered linear according to CAP linearity survey acceptance criteria. | Both serum and urine samples are considered linear according to the acceptance criteria of the CAP linearity survey. |
| Urine Preservatives | Recoveries compared to controls within an acceptable range. | Recoveries of urine preservatives compared to controls ranged from 97.5% to 99.1%. |
| Calibration Stability | Acceptable duration of calibration stability. | 25 days on the SYVA-30R Biochemical System. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for most of the individual tests. It mentions "human serum or plasma" and "human urine, serum, or plasma" as the sample types.
- Provenance: The document does not specify the country of origin of the data. It is generally implied to be from the United States given the FDA submission.
- Retrospective/Prospective: The document does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies performed are laboratory-based analytical performance studies, not clinical studies requiring expert interpretation of results for ground truth establishment in the traditional sense. The ground truth for these types of assays is established through reference methods or known concentrations, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are analytical performance assessments of an in vitro diagnostic device, not studies involving human interpretation or adjudication of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic tools where human readers interpret results, often with and without AI assistance. The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay, which is an automated chemical analysis, not subject to human reader interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are essentially standalone performance studies for the Emit® II Plus Ethyl Alcohol Assay. The device operates as an algorithm/assay without human intervention in the interpretation of the assay result itself. Its performance is measured directly against established analytical metrics and a predicate device.
7. The Type of Ground Truth Used:
The ground truth for these analytical studies is primarily established through:
- Reference Methods/Predicate Device: For comparative analysis, the predicate device (Emit® Ethyl Alcohol Assay K903153) served as the reference standard.
- Known Concentrations/Spiked Samples: For precision, sensitivity, spiked sample recovery, endogenous interference, high sample dilution, anticoagulant, and urine preservative studies, the ground truth would be the known concentrations or expected values of ethyl alcohol or interferents.
- CAP Linearity Survey Acceptance Criteria: For linearity, the ground truth/standard is defined by these external criteria.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay, which is a chemical reaction-based method, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its parameters are chemically and biochemically defined, not iteratively learned from data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, this device does not utilize a training set in the way an AI/ML algorithm would. The "ground truth" equivalent for developing such an assay would involve established biochemical principles, reagent formulations, optimization experiments, and quality control standards.
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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.
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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 <0.1 -- 14.2%.
Sensitivity: The sensitivity level of the Emit® II Plus Ethyl Alcohol Assay is less than 3.0 mg/dL. This level represents the lowest concentration of amphetamines that can be distinquished from 0 ng/mL with a confidence level of 95%.
Endogenous Interference: Endogenous interference in serum, due to either bilirubin, hemoglobin, or trigvcerides, in the Syva Emit® II Plus Ethyl Alcohol Assay are 99, 100, and 97% recovery compared to controls. The presence of LDH/Lactate does not cause a significant interference in the Svva Emit® II Plus Ethyl Alcohol Assay (0.4 mg/dL), A series of potentially interfering endogenous substances in urine were tested by the Syva Emit® II Plus Ethyl Alcohol Assav. The recoveries for the interfering substances range from 99 - 104%.
Spiked Sample Recovery: Spike recovery of ethanol in human serum and urine by the Syva Emit® II Plus Ethyl Alcohol Assay was performed across the quantitative range of between 10 and 600 mg/dL. Recovery of ethanol spikes ranged between 95.7 - 101.5%.
High Sample Dilution: Dilution of high serum and urine samples by water the Negative Calibrator were performed in the Syva Emit® II Plus Ethyl Alcohol Assav. Recovery from the normal concentrations in both types of samples diluted with either water or Negative Calibrator ranged from 97.1 - 100.9%.
Anticoagulants: The performance of the anticoagulants EDTA (K3), Sodium Citrate, Sodium Heparin, and Oxalate/Fluoride, as compared to serum, was assayed by the Syva Emit® II Plus Ethyl Alcohol Assay. Average recovery versus the serum control ranged from95.5 – 102.3%.
Linearity: The linearity of diluted serum and urine samples were tested in the Syva Emit® II Plus Ethyl Alcohol Assay. Both serum and urine samples are considered linear according to the acceptance criteria of the CAP linearity survey.
Urine Preservatives: the effect of urine preservatives was tested by the Syva Emit® II Plus Ethyl Alcohol Assay. Recoveries of urine preservatives compared to controls ranged from 97.5 -- 99.1%.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® Ethyl Alcohol Assay (cont.)
Calibration Stability: The calibration stability of the Syva Emit® II Plus Ethyl Alcohol Assay on the SYVA- 30R Biochemical System was determined to be 25 days.
5. Substantial Equivalence:
In conclusion, Syva Company considers the Emit® II Plus Ethyl Alcohol Assay to be substantially equivalent to the Ethyl Alcohol Assay (K903153) with regard to intended use, assay sample, and overall performance characteristics.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 2000
Mr. Paul L. Rogers Jr. Senior Manager, Regulatory Affairs Syva Company - Dade Behring Inc. P.O. Box 49013 3403 Yerba Buena Road San Jose, California 95161-9013
Re: K993980
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.
§ 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.