(58 days)
No
The description details a homogeneous enzyme immunoassay, a standard biochemical test method, and makes no mention of AI or ML technologies.
No
This device is an in vitro diagnostic reagent test kit for the qualitative or semi-quantitative analysis of opiates in human urine, used to screen for potential drugs of abuse. It does not treat or alleviate a disease or condition.
Yes
The "Intended Use" states that the assay is used "to screen for potential drugs of abuse" and the "Device Description" states it is an "in vitro diagnostic reagent test kit". These statements confirm its purpose as a diagnostic tool.
No
The device description explicitly states it is an "in vitro diagnostic reagent test kit," which indicates it is a physical kit containing chemical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the assay is "intended for use in the qualitative or semiquantitative analysis of opiates in human urine." This describes a test performed on a sample taken from the human body to provide information about a person's health or condition.
- Device Description: The "Device Description" section refers to the product as an "in vitro diagnostic reagent test kit." This directly identifies the device as an IVD.
- Sample Type: The assay analyzes "human urine," which is a biological sample taken from the body.
- Purpose: The assay is used to "screen for potential drugs of abuse," which is a diagnostic purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Emit® d.a.u.™ Opiates Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative or semiquantitative analysis of opiates in human urine. The assay is used to screen for potential drugs of abuse.
Product codes
DJG
Device Description
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
Syva Company is submitting the Premarket Notification, 510(k) to convey our intention to commercially distribute the modified Emit® d.a.u. ™ Opiates Assay, an in vitro diagnostic reagent test kit for the qualitative or semiquantitative (Emit® d.a.u." ** Opiates Assay at 300 ng/mL only) analysis of Opiates in human urine. The modified Emit® d.a.u. ™ Opiates Assay is a homogenous enzyme assay with a 300 ng/mL cutoff. The modified Emit® d.a.u. ™ Opiates Assay has been found to be equivalent to the predicate device: Emit® II Opiates 300/2000 Assay (K971596) with regard to intended use, assay sample, and overall performance characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis:
The modified Emit® d.a.u. TM Opiates Assay, utilizing the 2000 ng/mL cutoff, correctly distinguished spiked samples as positive or negative to the cutoff. The comparative analysis to the predicate method showed 100% agreement for positive specimens and 97% agreement for negative samples.
A Precision study was performed utilizing the 2000 ng/mL (qualitative) cutoff, the Precision: modified Emit® d.a.u.™ Opiates Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) as rates ranging from 0.84 to 1.18% and acceptable total precision with coefficients of variation (%CV) as rates ranging from 1.55 to 2.59%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
L984832
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® d.a.u. ™ Opiates Assay
1. Manufacturer and Contact Information:
Syva Company Manufacturer: 3403 Yerba Buena Rd. P.O. Box 49013 San Jose, CA 95161-9013
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 "Opiate Test System" as Class II. Reference: 21 CFR 862.3650, revised April 1, 1993.
3. Intended Use:
Emit® d.a.u.™ Opiates Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative or semiquantitative analysis of opiates 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.
Syva Company is submitting the Premarket Notification, 510(k) to convey our intention to commercially distribute the modified Emit® d.a.u. ™ Opiates Assay, an in vitro diagnostic reagent test kit for the qualitative or semiquantitative (Emit® d.a.u." ** Opiates Assay at 300 ng/mL only) analysis of Opiates in human urine. The modified Emit® d.a.u. ™ Opiates Assay is a homogenous enzyme assay with a 300 ng/mL cutoff. The modified Emit® d.a.u. ™ Opiates Assay has been found to be equivalent to the predicate device: Emit® II Opiates 300/2000 Assay (K971596) with regard to intended use, assay sample, and overall performance characteristics.
The modified Emit® d.a.u. TM Opiates Assay, utilizing the 2000 Comparative Analysis: ng/mL cutoff, correctly distinguished spiked samples as positive or negative to the cutoff. The comparative analysis to the predicate method showed 100% agreement for positive specimens and 97% agreement for negative samples.
A Precision study was performed utilizing the 2000 ng/mL (qualitative) cutoff, the Precision: modified Emit® d.a.u.™ Opiates Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) as rates ranging from 0.84 to 1.18% and acceptable total precision with coefficients of variation (%CV) as rates ranging from 1.55 to 2.59%.
5. Substantial Equivalence:
In conclusion, Syva Company considers the modified Emit® d.a.u. ™ Opiates Assay to be substantially equivalent to the Emit® II Opiates 300/2000 Assay (K971576) with regard to intended use, assay sample, and overall performance characteristics.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows a partial logo of what appears to be a government agency. The logo features a stylized graphic with three vertical, wavy lines that resemble a flag or banner. To the left of the graphic, the word "DEPART" is partially visible, suggesting the full word is "DEPARTMENT". The image is in black and white, with the logo elements appearing in solid black against a white background.
JAN 22 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Paul L. Rogers, Jr. Senior Manager, Regulatory Affairs Syva Company 3403 Yerba Buena Road P.O. Box 49013 San Jose, California 95161-9013
Re: K984232 Trade Name: Emit® d.a.u.™ Opiate Assay Regulatory Class: II Product Code: DJG Dated: November 23, 1998 Received: November 25, 1998
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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Page 2
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 Sutman
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
3
510(k) Number (If known):
Device Name: Emit® d.a.u.TM Opiates Assay
Indications for Use:
Emit® d.a.u. ™ Opiates Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative or semiquantitative analysis of opiates in human urine. The assay is used to screen for potential drugs of abuse.
fam Cogen
(Division Sign-Off)
Division of Clinical Laboratory Devices 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 | ✓ |
|---|---|
| Use |
(Per 21 CFR 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)