(57 days)
The Emit® II Plus Methadone Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methadone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Methadone Assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Syva Emit® II Plus Methadone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methadone in human urine.
Here's a breakdown of the acceptance criteria and study information for the Syva Emit® II Plus Methadone Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (150 ng/mL cutoff) | High agreement with GC/MS (predicate) | 95% agreement with GC/MS (reference method) |
| Qualitative Analysis (300 ng/mL cutoff) | High agreement with predicate device | 100% agreement with predicate device |
| Spiked-Sample Recovery (150 ng/mL cutoff) | Consistent distinction of negative/positive above/below cutoff | Consistently distinguished negative or positive for methadone spiked at levels < or = -25% of cutoff (0-112.5 ng/mL) and > or = +25% of cutoff (187.5-1500 ng/mL). |
| Spiked-Sample Recovery (300 ng/mL cutoff) | Consistent distinction of negative/positive above/below cutoff | Consistently distinguished negative or positive for methadone spiked at levels < or = -25% of cutoff (0-225 ng/mL) and > or = +25% of cutoff (375-3000 ng/mL). |
| Semiquantitative Recovery (150 ng/mL cutoff) | Acceptable recovery range | Within ± 13 % of nominal concentrations |
| Semiquantitative Recovery (300 ng/mL cutoff) | Acceptable recovery range | Within ± 20 % of nominal concentrations |
| Precision (Qualitative, 150 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 0.5-0.7%, Total CV: 1.2-1.7% |
| Precision (Qualitative, 300 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 0.6-0.7%, Total CV: 1.5-2.1% |
| Precision (Semiquantitative, 150 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 1.0%, Total CV: 2.3-3.0% |
| Precision (Semiquantitative, 300 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 0.9-1.1%, Total CV: 1.6-3.7% |
| Sensitivity (150 ng/mL cutoff) | Lowest concentration distinguishable from 0 ng/mL | Less than 10 ng/mL |
| Sensitivity (300 ng/mL cutoff) | Lowest concentration distinguishable from 0 ng/mL | Less than 20 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the test set in the comparative analysis, spiked-sample recovery, or precision studies.
The data provenance is not explicitly stated beyond "human urine" samples. There is no mention of country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The ground truth method (GC/MS or predicate device) is mentioned, but not the human involvement in its establishment or interpretation.
4. Adjudication Method for the Test Set:
This information is not provided in the document, as the evaluations primarily rely on objective analytical methods (GC/MS, predicate device, and laboratory measurements) rather than subjective expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is a laboratory assay, not an imaging or diagnostic tool requiring human interpretation comparison. The comparisons are between the new assay and a reference method (GC/MS) or a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation was conducted. The device (the Emit® II Plus Methadone Assay) is an automated enzyme immunoassay that provides analytical results without direct human interpretive involvement in the "loop" of the assay's output. Its performance was assessed directly against reference methods and internal precision controls.
7. The Type of Ground Truth Used:
- For Qualitative Analysis: Gas Chromatography/Mass Spectrometry (GC/MS) is explicitly stated as the "reference method" for the 150 ng/mL cutoff. For the 300 ng/mL cutoff, the predicate device (Syva Emit® II Methadone Assay) was used as the comparative standard, implying it served as the ground truth in that comparison.
- For Spiked-Sample Recovery: Known concentrations of methadone "spiked" into negative human urine samples were used as the ground truth.
- For Semiquantitative Recovery: Similar to spiked-sample recovery, known concentrations of methadone spiked into negative human urine were used as the ground truth.
- For Precision: The ground truth for precision studies would be the expected results (e.g., control values, calibrator concentrations) against which the assay's reproducibility is measured.
8. The Sample Size for the Training Set:
The sample size for any training set is not mentioned. This type of 510(k) summary for an in vitro diagnostic assay typically focuses on validation data rather than machine learning training data.
9. How the Ground Truth for the Training Set Was Established:
As no training set is described or implied, information on how its ground truth was established is not provided. This device is a biochemical assay, not an AI/ML-based diagnostic that would typically have a distinct "training set" in the common understanding of that term.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Methadone Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company–Dade Behring Inc.20400 Mariani Ave.San Jose, CA 95014 |
|---|---|
| Contact Information: | Paul RogersSyva Company–Dade Behring Inc. |
| 3403 Yerba Buena RoadSan Jose, CA 95161-9013 |
2. Device Classification Name:
"Methadone Test Systems" is a Class II device (21 CFR 862.3620, revised April 1, 1998)
Tel: 408-239-2309
3. Intended Use:
The Syva Emit® II Plus Methadone Assay is a homogeneous enzyme immunoassay with 150 ng/mL or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of methadone in human urine.
4. Device Description and Characteristics:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
The Syva Emit® II Plus Methadone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methadone in human urine.
The Syva Emit® II Plus Methadone Assay has been found to be equivalent to the predicate device, Syva Emit® II Methadone Assay with regard to analyte detected, intended use, and performance characteristics.
Comparative Analysis: The Syva Emit® II Plus Methadone Assay showed excellent correlation for qualitative analyses. With the 150 ng/mL cutoff, the Syva Emit® II Plus Methadone Assay resulted in 95 % agreement with the reference method, GC/MS, in finding specimens negative and positive. With the 300 ng/mL cutoff, comparative analysis of the Syva Emit® II Plus Methadone Assay to the predicate resulted in 100 % agreement in finding samples negative and positive.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Methadone Assay (cont.)
Spiked-Sample Recovery: In qualitative analysis, the Syva Emit® II Plus Methadone Assay correctly identified the spiked specimens as containing methadone either less than or greater than the dual cutoffs. 150 ng/mL or 300 ng/mL With the 150 ng/mL cutoff, known levels of methadone, spiked at levels less than or equal to minus 25 % of the cutoff (0 to 112.5 ng/mL) and spiked at levels greater than or equal to plus 25 % of the cutoff (187.5 to 1500 ng/mL), were consistently distinguished as negative or positive. With the 300 ng/mL cutoff, known levels of methadone, spiked at levels less than or equal to minus 25 % of the cutoff (0 to 225 ng/mL) and spiked at levels greater than or equal to plus 25 % of the cutoff (375 to 3000 ng/mL), were consistently distinguished as negative or positive.
The semiquantitative use was assessed by determining the accuracy of recovery for the analytespiked samples by the Syva Emit® II Plus Methadone Assay. Negative human urine was spiked with concentrations of methadone at levels throughout the semiquantitative ranges of 50 to 450 ng/mL (150 nq/mL cutoff) and 112.5 to 900 ng/mL (300 ng/mL cutoff). For each known concentration, drug recovery was calculated using the average concentration obtained by the Syva Emit® II Plus Methadone Assay. Within the semiguantitative range for the 150 ng/mL cutoff, recovery was within ± 13 % of the nominal concentrations of spiked analyte. Within the semiguantitative range for the 300 ng/mL cutoff, recovery was ± 20 % of the nominal concentrations of spiked analyte.
Precision: The Syva Emit® II Plus Methadone Assay was analyzed for precision in both qualitative (rates) and semiquantitative (concentration) modes for each cutoff. For both modes, acceptable within-run and total precision statistics, coefficients of variation (CV), were observed.
Qualitative results at the 150 ng/mL cutoff, determined from rates for controls and cutoff calibrator, gave values for within-run precision CV ranging from 0.5 to 0.7 % and values for total precision CV ranging from 1.2 to 1.7 %. Qualitative results at the 300 ng/mL cutoff, determined from rates for controls and cutoff calibrator, gave values for within-run precision CV ranging from 0.6 to 0.7 % and values for total precision CV ranging from 1.5 to 2.1 %.
Semiquantitative results at the 150 ng/mL cutoff, determined from concentrations for controls and cutoff calibrator, gave values for within-run precision CV of 1.0 % and values for total precision CV ranging from 2.3 to 3.0 %. Semiquantitative results at the 300 ng/mL cutoff, determined from concentrations for controls and cutoff calibrator, gave values for within-run precision CV ranging from 0.9 to 1.1 % and values for total precision CV ranging from 1.6 to 3.7 %.
Sensitivity: The sensitivity level of the Syva Emit® II Plus Methadone Assay is less than 10 ng/mL at the 150 ng/mL cutoff and is less than 20 ng/mL cutoff. This sensitivity level represents the lowest concentration of methadone that can be distinguished from 0 ng/mL with a confidence level of 95 %.
5. Substantial Equivalence:
In conclusion, Syva Company-Dade Behring Inc. considers the Syva Emit® II Plus Methadone Assay to be substantially equivalent to the Syva Emit® II Methadone Assay with regard to analyte detected, intended use, and performance characteristics.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
For Emit® II Plus Cannabinoid Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company – Dade Behring Inc.20400 Mariani Ave.Cupertino, CA 95014 |
|---|---|
| --------------- | ------------------------------------------------------------------------------- |
Contact Information: Paul Rogers 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 has classified "Cannabinoid Test System" as Class II.
3. Intended Use:
The Emit® II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
4. Device Description and Characteristics:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
The Emit® II Plus Cannabinoid Assay is a drugs-of-abuse homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of Cannabinoids in human urine. The Emit® II Plus Cannabinoid Assay has been found to be equivalent to the predicate devices, Emit® II Cannabinoid Assays, 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 stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circle, with the department name on the left and "USA" on the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 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: K994005
Trade Name: Syva Emit® II Plus Methadone Assay Regulatory Class: II Product Code: DJR Dated: November 22, 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 OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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 Putman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Affina of Nation, Demluntion - 1
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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K994005 510(k) Number (If known):
Device Name: Syva Emit® II Plus Methadone Assay
Indications for Use:
The Emit® II Plus Methadone Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methadone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Methadone Assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Stantogen
Division Sign-Off
(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)
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).