(29 days)
Not Found
No
The document describes a reagent kit for a qualitative chemical assay, not a software or imaging device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.
No
Explanation: This device is for qualitative determination of opiates in human urine, which is a diagnostic purpose, not a therapeutic one. Therapeutic devices are used for treatment or prevention of disease.
Yes
The device is intended for the qualitative determination of opiates in human urine, providing a preliminary analytical result which can be used to screen for the presence of opiates. This aligns with the definition of a diagnostic device as it is used to identify a condition or substance (opiates) in a biological sample.
No
The device description clearly states it is a "reagent" designed for use on "SYNCHRON Systems," which are laboratory analyzers. This indicates a chemical reagent and associated hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of opiates in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Sample Type: The device analyzes "human urine," which is a biological specimen.
- Purpose: The purpose is to screen for the presence of opiates, which is a diagnostic activity.
- Device Description: It's a "reagent" designed for use on "SYNCHRON Systems," which are laboratory analyzers. This further indicates it's used in a laboratory setting for diagnostic testing.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device fits that definition.
N/A
Intended Use / Indications for Use
Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON® System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.
The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.12
Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
DJG
Device Description
The SYNCHRON Systems Opiate (OP) reagent is designed for optimal SYNCHRON performance on on the CX (CX4/4CE/4A/4PRO, CX5/5CE/5A/5PRO. CX7/7RTS/7Δ/7PRO. CX9ALX/9PRO) and LX (LX20/PRO/LXi) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data from validation testing supports equivalency.
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
APR 2 9 2003
510(k) SUMMARY
1.0 Submitted Bv:
Kim Walker Senior Requlatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
Date Submitted 2.0
March 25, 2003
3.0 Device Name(s):
- 3.1 Proprietary Names SYNCHRON Systems Opiate Reagent
- 3.2 Classification Names Opiate test system. [862.3650]
4.0 Legally Marketed Device
The SYNCHRON Systems Opiate Reagent claims substantial equivalence to the SYNCHRON Systems Opiate Reagent currently in commercial distribution. (FDA 510(k) Number K944606)
5.0 Device Description
The SYNCHRON Systems Opiate (OP) reagent is designed for optimal SYNCHRON performance on on the CX (CX4/4CE/4A/4PRO, CX5/5CE/5A/5PRO. CX7/7RTS/7Δ/7PRO. CX9ALX/9PRO) and LX (LX20/PRO/LXi) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.
1
6.0 Intended Use
Opiate 300 nq (OP) Reagent, in conjunction with the SYNCHRON® System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.
The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.12
Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)
The SYNCHRON Systems Opiate reagent antibody has been modified for drug cross-reactivity.
8.0 Summary of Performance Data
Performance data from validation testing supports equivalency.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy line.
APR 2 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104, Box 8000 Brea, CA 92822-8000
Re: K031002
Trade/Device Name: SYNCHRON® Systems Opiate Reagent Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: March 25, 2003 Received: March 31, 2003
Dear Ms. Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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page 1 of 1
510(k) Number (if known):
SYNCHRON® Systems Opiate Reagent Device Name:
Indications for Use:
Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON® System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.
The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.12
Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
i
OR
Prescription Use
(per 21 CFR 801.109)
Over-the-Counter Use
Optional Format 1-2-96
Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K031002
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Opiate Reagent File: OP_s510(k).doc 03/03