(64 days)
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No
The description focuses on a homogeneous enzyme immunoassay and its performance characteristics, with no mention of AI or ML.
No.
The device is an in-vitro diagnostic assay used to detect amphetamines in urine samples, which provides analytical test results, not a therapeutic treatment.
Yes
The device is an immunoassay intended for the qualitative and semiquantitative analysis of amphetamines in human urine. It is used to provide a preliminary analytical test result for drugs-of-abuse, which falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "homogenous enzyme assay," which is a chemical process involving reagents and a chemistry analyzer, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative and semiquantitative analyses of amphetamines in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (presence of amphetamines).
- Device Description: The description confirms it's a "homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of amphetamines urine." This further supports the in vitro nature of the test.
- Anatomical Site: The specified anatomical site is "human urine," which is a biological specimen collected from a human.
- Performance Studies: The performance studies describe testing with "human urine specimens," confirming the use of biological samples.
All these points 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 purposes.
N/A
Intended Use / Indications for Use
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine.
Product codes (comma separated list FDA assigned to the subject device)
LAF, DZK
Device Description
The Syva Emit® II Plus Monoclonal Amphetamine/ Methamphetamine Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of amphetamines urine.
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
human urine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis: The Syva Emit® II Plus Monoclonal Amphetamine/ Methamphetamine Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in complete agreement in finding samples negative and positive.
Spiked Sample Recovery: In qualitative spike analysis, the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay using a 1000 ng/mL cutoff correctly identified the spiked specimens as being negative and positive. Known levels of methamphetamine, spiked at levels less than or equal to minus 25% of the cutoff (0 to 750 ng/mL) were consistently distinguished as negative and those spiked at levels greater than or equal to plus 25% of the cutoff (1250 to 6000 ng/mL) were consistently distinguished as positive.
The semiguantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. Negative human urine specimens were spiked with concentrations of dmethamphetamine at levels throughout the semiquantitative range of 500 to 1800 ng/ml. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. Within this range, recovery ranged up to ± 9% of nominal concentrations of spiked analvte.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: The sensitivity level of the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay is less than 500 ng/mL. This level represents the lowest concentration of amphetamines that can be distinguished from 0 ng/mL with a confidence level of 95%.
Precision: A precision study was performed using Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay in both the qualitative and semiqualitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative assays were observed.
Qualitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with coefficients of variation (CV) of 0.4% and total precision with CV ranging from 0.7 -- 0.9%.
Semiquantitative results, determined from concentrations for controls and cutoff calibrator, demonstrated within-run precision with CV ranqing from 1.2 - 1.9% and total precision with CV ranging from 2.4 - 4.3%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Syva Emit® II Monoclonal Amphetamine/Methamphetamine Assay
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).
0
993982
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company – Dade Behring Inc.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose, CA 95161-9013 |
| --------------- | ------------------------------------------------------------------------------------------------------- |
|---|
| Contact Information: | Paul Rogers |
|---|---|
| Syva Company | |
| 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 "Amphetamine Test System" as Class II.
3. Intended Use:
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines 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 Monoclonal Amphetamine/ Methamphetamine Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of amphetamines urine.
The Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay has been found to be equivalent to the predicate device: Syva Emit® II Monoclonal Amphetamine/Methamphetamine Assay with regard to intended use, assay sample, and overall performance characteristics.
Comparative Analysis: The Syva Emit® II Plus Monoclonal Amphetamine/ Methamphetamine Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in complete agreement in finding samples negative and positive.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit Monoclonal Amphetamine/Methamphetamine Assay (cont.)
Spiked Sample Recovery: In qualitative spike analysis, the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay using a 1000 ng/mL cutoff correctly identified the spiked specimens as being negative and positive. Known levels of methamphetamine, spiked at levels less than or equal to minus 25% of the cutoff (0 to 750 ng/mL) were consistently distinguished as negative and those spiked at levels greater than or equal to plus 25% of the cutoff (1250 to 6000 ng/mL) were consistently distinguished as positive.
The semiguantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. Negative human urine specimens were spiked with concentrations of dmethamphetamine at levels throughout the semiquantitative range of 500 to 1800 ng/ml.. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. Within this range, recovery ranged up to ± 9% of nominal concentrations of spiked analvte.
Precision: A precision study was performed using Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay in both the qualitative and semiqualitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative assays were observed.
Qualitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with coefficients of variation (CV) of 0.4% and total precision with CV ranging from 0.7 -- 0.9%.
Semiquantitative results, determined from concentrations for controls and cutoff calibrator, demonstrated within-run precision with CV ranqing from 1.2 - 1.9% and total precision with CV ranging from 2.4 - 4.3%.
Sensitivity: The sensitivity level of the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay is less than 500 ng/mL. This level represents the lowest concentration of amphetamines 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 Monoclonal Amphetamine/Methamphetamine Assay to be substantially equivalent to the Emit® II Monoclonal Amphetamine Assay with regard to intended use, assay sample, and overall performance characteristics.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
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: K993982
Trade Name: Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay Regulatory Class: II Product Code: LAF, DZK 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 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 Butman
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
4
Device Name: Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay
Indications for Use:
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Monoclonal Amphetamine/Methamphetamine 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.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
K193552
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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)