(71 days)
Not Found
No
The summary describes a reagent for a laboratory system, not a device with AI/ML capabilities. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No.
This device is a reagent used for the qualitative determination of opiates in human urine, indicating it is an in-vitro diagnostic device, not a therapeutic one.
Yes
The device is described as being for "qualitative determination of Opiates in human urine," which clearly indicates its use in detecting a specific substance in a biological sample to provide information about a patient's health status, fitting the definition of a diagnostic device.
No
The device is a reagent, which is a chemical substance used in a laboratory test. It is packaged in cartridges and used on a SYNCHRON System, indicating it is a physical component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative determination of Opiates in human urine". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide diagnostic information about the presence of opiates.
- Device Description: The device is a "Reagent" used in conjunction with "Calibrators" for testing. Reagents and calibrators are common components of IVD test systems.
- Performance Studies: The summary of performance studies mentions "safety and effectiveness" and comparison to "Opiate Test Systems already in commercial distribution," which are typical considerations for IVD devices seeking regulatory clearance.
- Predicate Device: The mention of a "Predicate Device" (Emit® II Opiates 300/2000 Assay) is a strong indicator that this device is being compared to an existing IVD device for regulatory purposes.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The SYNCHRON® Systems DAT Opiates Reagent is in a ready-to-use liquid format and packaged into bar coded cartridges that are placed directly onto the SYNCHRON Systems.
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to Opiate Test Systems already in commercial distribution. Stress stability studies of the Opiates 2000 ng Reagent support the Beckman stability claim of 12 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
K9841152
JAN 29 1999
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye or wave. To the right of the circle are the words "BECKMAN" stacked on top of "COULTER", both in a bold, sans-serif font.
Summary of Safety & Effectiveness SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent
1.0 Submitted By:
Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted:
November 17, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Opiates 2000 ng Reagent
3.2 Classification Name
Opiate Test System (21 CFR §862.3650)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------------|------------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems
Opiate 2000 ng Reagent | Emit® II Opiates
300/2000 Assay | Behring Diagnostics,
Inc.* | K971596 |
*Behring Diagnostics, Inc. (formerly SYVA), Cupertino, CA
5.0 Description:
The SYNCHRON® Systems DAT Opiates Reagent is in a ready-to-use liquid format and packaged into bar coded cartridges that are placed directly onto the SYNCHRON Systems.
Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
1
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Opiates 2000 ng Reagent Summary of Safety & Effectiveness
5.0 Intended Use:
The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.
7.0 Comparison to Predicate(s):
Same intended use and chemical reaction as the predicate. The SYNCHRON Opiates 2000 ng Reagent uses mouse antibodies and the Emit II Opiates Reagent uses goat antibodies.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to Opiate Test Systems already in commercial distribution. Stress stability studies of the Opiates 2000 ng Reagent support the Beckman stability claim of 12 months.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 29 1999
Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92622-8000
Re: K984152
Trade Name: SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent Regulatory Class: II Product Code: DJG Dated: January 14, 1999 Received: January 19, 1999
Dear Ms. Stockert:
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.
3
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
4
page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Not yet assigned
Device Name: SYNCHRON® Systems Opiates 2000 ng Reagent
Indications for Use:
The SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.
21 CFR 862.3650 Opiates 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 heroin. codeine, nalorphine, and meperedine. alucoronide. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and monitoring the levels of opiate administration to ensure appropriate therapy.
| (b) Classification. Class II. | |
|---|---|
| Dean Cooper | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number: | K984152 |
| Dean Cooge | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | x 984152 |
(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)
Over-the-Counter Use Optional Format 1-2-96