(64 days)
Emit® II Barbiturate Assay
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No
The summary describes a homogeneous enzyme immunoassay and does not mention any AI or ML components.
No
This device is an in vitro diagnostic assay used for the qualitative and semiquantitative analysis of barbiturates in human urine, which provides analytical test results and is not used for treating a disease or condition.
Yes
The device is described as an immunoassay intended for qualitative and semiquantitative analysis of barbiturates in human urine, providing a preliminary analytical test result. This analysis of biological samples to detect a specific substance indicates a diagnostic purpose.
No
The device is described as a "homogeneous enzyme immunoassay" and an "assay," which are chemical tests involving reagents and reactions, not purely software. It is also intended for use with "chemistry analyzers," which are hardware devices.
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 analysis of barbiturates in the 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 barbiturates).
- Device Description: The description reinforces the intended use of analyzing barbiturates in human urine.
- Homogeneous Enzyme Immunoassay: This is a common type of assay used in clinical laboratories for in vitro testing.
- Analysis of Barbiturates in Human Urine: This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
The fact that it provides a "preliminary analytical test result" and requires a "more specific alternative chemical method" for confirmation is also typical for many IVD screening tests.
N/A
Intended Use / Indications for Use
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of barbiturates in the human urine. Emit® II assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Barbiturate 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.
Product codes
KLT
Device Description
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of barbiturates in human urine. The Emit® II Plus Barbiturate Assay has been found to be equivalent to the predicate device. Emit® II Barbiturate 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
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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
Comparative Analysis: The Syva Emit® II Plus Barbiturate Assay showed excellent correlation to the Emit® II Barbiturate Assay (predicate method). The comparative analysis to the predicate method resulted in 94% agreement at the 200 ng/mL cutoff and 100% agreement at the 300ng/mL cutoff in finding samples negative and positive.
Spiked Sample Recovery: Analysis of spiked sample recovery by the qualitative mode of the Emit II Plus Barbiturate Assay correctly identified the spiked specimens containing equal to or less than () plus (+) 25% of 200 ng/mL secobarbital as positive. The Emit® II Plus Barbiturate Assay also correctly identified the spiked specimens containing equal to or less than () plus (+) 25% of 300 ng/mL secobarbital as positive.
The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Barbiturate Assay. Negative human urine specimens were spiked with concentrations of secobarbital at levels throughout the semiquantitative range of 200 to 800 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit II Plus Barbiturate Assay. Within this range, recovery was within 99%-114% of nominal concentrations of spiked analyte.
Precision: A precision study was performed using Syva Emit® II Plus Barbiturate Assay in both the qualitative and semiguantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative modes of the assays were observed.
In the qualitative mode of the Emit® II Barbiturate Assay, the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.4 - 0.5% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.6 - 0.7%.
In the semiquantitative mode of the assay the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (concentrations) ranging from 1.0 - 3.8% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 1.9-4.2%.
Key Metrics
Sensitivity: The sensitivity level of the Emit® II Plus Barbiturate Assay is less than 20 ng/mL. This level represents the lowest concentration of secobarbital that can be distinguished from 0 ng/mL with a confidence level of 95%.
Predicate Device(s)
Emit® II Barbiturate Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string is 'K993987'. The characters are written in a simple, slightly slanted style. The image appears to be a close-up of the handwritten string.
JAN 2 7 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® Il Plus Barbiturate Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company - Dade Behring Inc.
20400 Mariani Ave.
Cupertino, CA 95014 |
| --------------- | ------------------------------------------------------------------------------- |
|---|
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 has classified "BarbiturateTest System" as Class II.
3. Intended Use:
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of barbiturates in the human urine. Emit® II assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Barbiturate 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.
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 Barbiturate Assay is a drugs-of-abuse homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of barbiturates in human urine. The Emit® II Plus Barbiturate Assay has been found to be equivalent to the predicate device. Emit® II Barbiturate Assay, with regard to intended use, assay sample, and overall performance characteristics.
Comparative Analysis: The Syva Emit® II Plus Barbiturate Assay showed excellent correlation to the Emit® II Barbiturate Assay (predicate method). The comparative analysis to the predicate method resulted in 94% agreement at the 200 ng/mL cutoff and 100% agreement at the 300ng/mL cutoff in finding samples negative and positive.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Barbiturate Assay (cont.)
Spiked Sample Recovery: Analysis of spiked sample recovery by the qualitative mode of the Emit II Plus Barbiturate Assay correctly identified the spiked specimens containing equal to or less than () plus (+) 25% of 200 ng/mL secobarbital as positive. The Emit® II Plus Barbiturate Assay also correctly identified the spiked specimens containing equal to or less than () plus (+) 25% of 300 ng/mL secobarbital as positive.
The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Barbiturate Assay. Negative human urine specimens were spiked with concentrations of secobarbital at levels throughout the semiquantitative range of 200 to 800 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit II Plus Barbiturate Assay. Within this range, recovery was within 99%-114% of nominal concentrations of spiked analyte.
Precision: A precision study was performed using Syva Emit® II Plus Barbiturate Assay in both the qualitative and semiguantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative modes of the assays were observed.
In the qualitative mode of the Emit® II Barbiturate Assay, the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.4 - 0.5% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.6 - 0.7%.
In the semiquantitative mode of the assay the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (concentrations) ranging from 1.0 - 3.8% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 1.9-4.2%.
Sensitivity: The sensitivity level of the Emit® II Plus Barbiturate Assay is less than 20 ng/mL. This level represents the lowest concentration of secobarbital 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 Barbiturate Assay to be substantially equivalent to the Emit® II Barbiturate 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 image of an eagle with three stripes forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JAN 2 7 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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: K993987
Trade Name: Syva Emit® II Plus Barbiturate Assay Regulatory Class: II Product Code: KLT Dated: November 24, 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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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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Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '993987'. The characters are written in a cursive style, with varying stroke thicknesses.
Device Name: Syva Emit® II Plus Barbiturate Assay
Indications for Use:
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of barbiturates in the human urine. Emit® II assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Barbiturate 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.
Lean Cooge
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number +