(64 days)
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No
The summary describes a homogeneous enzyme immunoassay and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic assay used for qualitative and semiquantitative analysis of benzodiazepines in human urine, which is for diagnostic purposes, not therapeutic.
Yes
The device is intended for the qualitative and semiquantitative analyses of benzodiazepines in human urine, which provides a preliminary analytical test result for diagnostic purposes.
No
The device is a homogeneous enzyme immunoassay, which is a chemical assay kit, not a software-only device. It is intended for use with chemistry analyzers, which are hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semiquantitative analyses of benzodiazepines in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description reinforces that it's a "homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of benzodiazepines in human urine."
- Performance Studies: The document details performance studies like comparative analysis, spiked sample recovery, precision, and sensitivity, which are typical evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (Syva Emit® II Benzodiazepine Assay) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Syva Emit® II Plus Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200ng/mL or 300ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of benzodiazepines in human urine. Syva Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Syva Emit® II Plus Benzodiazepine 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.
Product codes (comma separated list FDA assigned to the subject device)
JXM
Device Description
The Syva Emit® II Plus Benzodiazepine Assay is a homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of benzodiazepines in human urine. The Syva Emit® II Plus Benzodiazepine Assay has been found to be equivalent to the predicate device. Syva Emit® II Benzodiazepine Assay 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
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 Benzodiazepine Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a 97% agreement for the 200ng/mL cutoff and a 84% agreement for the 300ng/mL cutoff. The discordance between the test and predicate method can be explained by the fact that there are different calibrator drugs in the two methods. The calibrators used with the Syva Emit® II Plus Benzodiazepine Assay contain the benzodiazepine, lormetazepam, while the calibrators used with the Syva Emit® II Benzodiazepine Assay contain the benzodiazepine, The use of lormetazepam as the calibrator analyte increases the apparent sensitivity of the Syva Emit® II Plus Benzodiazepine Assay to various benzodiazepines.
Spiked Sample Recovery: In qualitative spike analysis of lormetazepam in negative human urine specimens, the Syva Emit® II Plus Benzodiazepine Assay using a cutoff of 200 ng/mL and a cutoff of 300 ng/mL correctly identified the spiked specimens containing less than or equal to minus 25% of the respective cutoffs as negative and the spiked specimens containing greater than or equal to plus 25% of the respective cutoffs as positive.
The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Syva Emit® II Plus Benzodiazepine Assay. Negative human urine specimens were spiked with concentrations of lormetazepam at levels throughout the semiguantitative range of 40 to 900 ng/mL. For each known concentration. drug recovery was calculated using the average concentration obtained by the Syva Emit® II Plus Benzodiazepine Assay. Within this range, recovery was within 85-118% of nominal concentrations of spiked analyte.
Precision: A precision study was performed using Syva Emit® II Plus Benzodiazepine Assay in both the qualitative and semiquantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiguantitative assays were observed.
Qualitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with coefficients of variation (CV) ranging from 0.4 - 0.7% and total precision with CV ranging from 0.7 - 1.0%.
Semiquantitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with CV ranging from 1.8 - 5.2% and total precision with CV ranging from 2.3 - 5.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: The sensitivity level of the Syva Emit® II Plus Benzodiazepine Assay is less than 15 ng/mL. This level represents the lowest concentration of benzodiazepines that can be distinguished from 0 ng/mL with a confidence level of 95%.
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 Benzodiazepine 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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§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).
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Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '993985'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Benzodiazepine Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company - Dade Behring Inc.
20400 Mariani Ave.
Cupertino, CA 95014 |
| --------------- | ------------------------------------------------------------------------------- |
|---|
Paul Rogers Contact Information: 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 "BenzodiazepineTest System" as Class II.
3. Intended Use:
The Syva Emit® II Plus Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200ng/mL or 300ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of benzodiazepines 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 Benzodiazepine Assay is a homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of benzodiazepines in human urine.
The Syva Emit® II Plus Benzodiazepine Assay has been found to be equivalent to the predicate device. Syva Emit® II Benzodiazepine Assay with regard to intended use, assay sample, and overall performance characteristics.
Comparative Analysis: The Syva Emit® II Plus Benzodiazepine Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a 97% agreement for the 200ng/mL cutoff and a 84% agreement for the 300ng/mL cutoff. The discordance between the test and predicate method can be explained by the fact that there are different calibrator drugs in the two methods. The calibrators used with the Syva Emit® II Plus Benzodiazepine Assay contain the benzodiazepine, lormetazepam, while the calibrators used with the Syva Emit® II Benzodiazepine Assay contain the benzodiazepine, The use of lormetazepam as the calibrator analyte increases the apparent sensitivity of the Syva Emit® II Plus Benzodiazepine Assay to various benzodiazepines.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® Il Plus Benzodiazepine Assay (cont.)
Spiked Sample Recovery: In qualitative spike analysis of lormetazepam in negative human urine specimens, the Syva Emit® II Plus Benzodiazepine Assay using a cutoff of 200 ng/mL and a cutoff of 300 ng/mL correctly identified the spiked specimens containing less than or equal to minus 25% of the respective cutoffs as negative and the spiked specimens containing greater than or equal to plus 25% of the respective cutoffs as positive.
The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Syva Emit® II Plus Benzodiazepine Assay. Negative human urine specimens were spiked with concentrations of lormetazepam at levels throughout the semiguantitative range of 40 to 900 ng/mL. For each known concentration. drug recovery was calculated using the average concentration obtained by the Syva Emit® II Plus Benzodiazepine Assay. Within this range, recovery was within 85-118% of nominal concentrations of spiked analyte.
Precision: A precision study was performed using Syva Emit® II Plus Benzodiazepine Assay in both the qualitative and semiquantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiguantitative assays were observed.
Qualitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with coefficients of variation (CV) ranging from 0.4 - 0.7% and total precision with CV ranging from 0.7 - 1.0%.
Semiquantitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with CV ranging from 1.8 - 5.2% and total precision with CV ranging from 2.3 - 5.6%.
Sensitivity: The sensitivity level of the Syva Emit® II Plus Benzodiazepine Assay is less than 15 ng/mL. This level represents the lowest concentration of benzodiazepines 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 Benzodiazepine Assay to be substantially equivalent to the Syva Emit® II Benzodiazepine 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 & Human Services. The logo consists of a stylized eagle symbol with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
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: K993985
Trade Name: Syva Emit® II Plus Benzodiazepine Assay Regulatory Class: II Product Code: JXM 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 (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 vours.
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
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Device Name: Syva Emit® II Plus Benzodiazepine Assay
Indications for Use:
The Syva Emit® II Plus Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzodiazepines in human urine. Syva Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Syva Emit® II Plus Benzodiazepine 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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k 993985
(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) |