(64 days)
The Emit® II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Methaqualone Assay provides only a preliminary analytical test result. A more specific alternative chemical method 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 Methaqualone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methaqualone in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Based on the provided 510(k) summary, the device is an in-vitro diagnostic assay, not an AI device or one that involves human interpretation in the way the questions usually imply (e.g., radiologists interpreting images). Therefore, many of the requested fields (like number of experts, adjudication methods, MRMC studies) are not applicable in this context. The acceptance criteria and performance are focused on the analytical performance of the assay itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Comparative Analysis (Qualitative) | Substantial equivalence to predicate device; high agreement in finding specimens negative and positive. (Implied for substantial equivalence) | 98% agreement with the predicate device in finding specimens negative and positive. |
| Spiked-Sample Recovery (Qualitative) | Correct identification of spiked specimens relative to the 300 ng/mL cutoff. Should consistently distinguish negative/positive for certain ranges around cutoff. | Correctly identified spiked specimens < 300 ng/mL as negative. Correctly identified spiked specimens > 300 ng/mL as positive. Consistently distinguished as negative or positive for levels ≤ 25% below cutoff (0-225 ng/mL) and ≥ 25% above cutoff (375-3000 ng/mL). |
| Spiked-Sample Recovery (Semiquantitative) | Recovery within 15% of nominal concentrations for spiked analytes within the semiquantitative range. | Within the semiquantitative range of 150 to 900 ng/mL, recovery was within 15% of the nominal concentrations of spiked analyte. |
| Precision (Qualitative Rate) | Acceptable within-run and total precision statistics, Coefficients of Variation (CV) (Implied). | Within-run precision CV: 0.4% to 0.5%. Total precision CV: 0.5% to 0.7%. |
| Precision (Semiquantitative Concentration) | Acceptable within-run and total precision statistics, Coefficients of Variation (CV) (Implied). | Within-run CV: 0.9% to 1.0%. Total precision CV: 1.2% to 1.7%. |
| Sensitivity | Ability to distinguish lowest concentration from 0 ng/mL with 95% confidence. (Implied) | Sensitivity less than 43 ng/mL (represents the lowest concentration of methaqualone that can be distinguished from 0 ng/mL with a confidence level of 95%). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Comparative Analysis: Not explicitly stated how many specimens were used, but the summary refers to "specimens" from which 98% agreement was observed.
- Sample Size for Spiked-Sample Recovery: "Negative human urine" was spiked, but the number of unique samples or total tests is not specified.
- Sample Size for Precision: Controls and cutoff calibrator were used, but the specific number of runs or repetitions is not specified.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective laboratory studies conducted by the manufacturer, rather than retrospective analysis of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an in-vitro diagnostic assay. The "ground truth" for the test set is established by the known concentrations of methaqualone in spiked samples or by the results of a predicate method, not by human expert interpretation.
4. Adjudication Method for the Test Set
N/A. Adjudication is not applicable as this involves quantitative and qualitative chemical analysis, which relies on objective measurements rather than subjective human interpretation needing consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not applicable to an in-vitro diagnostic assay that performs chemical analysis. It's typically used for imaging or diagnostic aids that involve human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The studies described (comparative analysis, spiked-sample recovery, precision, sensitivity) assess the performance of the assay itself as a standalone diagnostic tool, without human intervention in the result generation or interpretation to improve its core output. The assay produces a direct qualitative (positive/negative) or semiquantitative result. The "human-in-the-loop" aspect for such devices typically refers to the clinician's overall judgment in interpreting the test result in the context of a patient's condition, which is a broader clinical practice rather than an integral part of the device's performance study for regulatory approval.
7. The Type of Ground Truth Used
- Comparative Analysis: The results from the predicate device (Syva Emit® II Methaqualone Assay) served as the reference or "ground truth" for comparison.
- Spiked-Sample Recovery: The known, pre-determined concentrations of methaqualone spiked into negative human urine served as the ground truth.
- Precision: Internal controls and calibrators with known values were used.
- Sensitivity: Established by statistical methods comparing assay response to 0 ng/mL.
8. The Sample Size for the Training Set
N/A for this type of device. There isn't a "training set" in the context of machine learning or AI. The assay's chemical formulation and parameters are developed through laboratory optimization processes, not through training on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
N/A. See explanation in point 8.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Methaqualone Assay
Manufacturer and Contact Information: 1.
| Manufacturer: | Syva Company-Dade Behring Inc.20400 Mariani Ave.San Jose, CA 95014 |
|---|---|
| Contact Information: | Paul RogersSyva Company-Dade Behring Inc. |
3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: 408-239-2309
Device Classification Name: 2.
"Methaqualone Test Systems" is a Class II device (21 CFR 862.3630, revised April 1, 1998).
3. Intended Use:
The Syva Emit® II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine.
Device Description and Characteristics: 4.
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
The Syva Emit® II Plus Methaqualone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methaqualone in human urine.
The Syva Emit® II Plus Methaqualone Assay has been found to be equivalent to the predicate device, Syva Emit® II Methaqualone Assay, with regard to analyte detected, intended use, and performance characteristics.
Comparative Analysis: The Syva Emit® II Plus Methaqualone Assay showed excellent correlation to the predicate method. The comparative analyses to the predicate method resulted in 98 % agreement in finding specimens negative and positive.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® Il Plus Methaqualone Assay (cont.)
Spiked-Sample Recovery: In qualitative spike analysis, the Syva Emit® II Plus Methaqualone Assay correctly identified the spiked specimens containing less than 300 ng/mL methaqualone as neqative and the spiked specimens containing greater than 300 ng/mL methaqualone as positive. Known levels of methaqualone, spiked at levels less than or equal to minus 25 % of the cutoff (0 to 225 nq/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 analyte-spiked samples by the Syva Emit® II Plus Methaqualone Assay. Negative human urine was spiked with concentrations of methaqualone at levels throughout the semiguantitative range of 150 to 900 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Methaqualone Assay. Within this range, recovery was within 15% of the nominal concentrations of spiked analyte.
Precision: The Syva Emit® II Plus Methaqualone Assay was analyzed for precision in both qualitative (rate) and semiquantitative (concentration) modes. For both modes, acceptable within-run and total precision statistics, coefficients of variation (CV), were observed.
Qualitative results, determined from rates for controls and cutoff calibrator, gave values for within-run precision CV ranging from 0.4 to 0.5 % and values for total precision CV ranging from 0.5 to 0.7 %.
Semiguantitative results, determined from concentrations for controls and cutoff calibrator, gave values for within-run CV ranging from 0.9 to 1.0 % and values for total precision CV ranging from 1.2 to 1.7 %.
Sensitivity: The sensitivity level of the Syva Emit® II Plus Methaqualone Assay is less than 43 ng/mL. This level represents the lowest concentration of methaqualone 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 Methaqualone Assay to be substantially equivalent to the Syva Emit® II Methaqualone Assay with regard to analyte detected, intended use, and performance characteristics.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 7 2000
Mr. Paul L. Rogers, Jr. Senior Manager, Regulatory Affairs Syva Company - Dade Behring Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, California 95161-9013
Re: K993986
Trade Name: Syva Emit® II Plus Methaqualone Assay Regulatory Class: II Product Code: KXS 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 (QS) 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):
Device Name: Syva Emit® II Plus Methaqualone Assay
Indications for Use:
The Emit® II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Methaqualone Assay provides only a preliminary analytical test result. A more specific alternative chemical method 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.
Raul Cooper
(Division Sign-Off)
vision of Clinical Labo 510(k) Number
(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)
§ 862.3630 Methaqualone test system.
(a)
Identification. A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.(b)
Classification. Class II (special controls). A methaqualone 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).