(55 days)
Not Found
No
The summary describes a reagent kit for a chemical assay on a laboratory analyzer, with no mention of AI or ML technologies.
No
This device is for the qualitative determination of benzodiazepines in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The device qualitatively determines benzodiazepines in human urine, which is a screening procedure for diagnostic purposes (determining the presence of a substance in the body). Although it provides a "preliminary analytical result" and requires confirmation, it is still part of a diagnostic process.
No
The device description clearly states it is a "reagent" and a "reagent kit," which are chemical substances used in laboratory tests, not software. It is designed for use on specific hardware systems (SYNCHRON CX and LX Systems).
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 benzodiazepines in human urine." This is a test performed on a sample taken from the human body (urine) to provide information about a person's health status (presence of benzodiazepines).
- Device Description: The device is a "reagent" designed for use on "SYNCHRON Systems," which are laboratory instruments. This further indicates it's a component of a diagnostic testing system.
- Context: The entire description is focused on a laboratory test for drugs of abuse in urine, which is a common application for IVDs.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device fits that definition.
N/A
Intended Use / Indications for Use
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines 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.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
JXM
Device Description
The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) 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
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)
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
§ 862.3170 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).
0
NOV 7 2002
510(k) SUMMARY
1.0 Submitted By:
Annette Hellie Requlatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123
2.0 Date Submitted
September 12, 2002
3.0 Device Name(s):
- 3.1 Proprietary Names SYNCHRON Systems Benzodiazepine Reagent
- 3.2 Classification Names Benzodiazepine test system. [862.3170]
4.0 Legally Marketed Device
The SYNCHRON Systems Benzodiazepine Reagent claims substantial equivalence to the SYNCHRON Systems Benzodiazepine Reagent currently in commercial distribution. (FDA 510(k) Number K944076)
5.0 Device Description
The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.
1
6.0 Intended Use
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 nq/mL, on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines 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.
Clinical consideration and professional judgment 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 Benzodiazepine 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/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three overlapping human figures.
NOV 7 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 P.O. Box 8000 Brea. CA 92822-8000
Re:
Trade/Device Name: Synchron® Systems Benzodiazepine Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Antimony test system Regulatory Class: Class II Product Code: JXM Dated: October 24, 2002 Received: October 24, 2002
Dear Ms. Hellie:
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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 vour 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 1 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 veneral 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/cdrb/dsmaldsmamain.html".
Sincerely yours.
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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page 1 of 1
03304 510(k) Number (if known):
SYNCHRON® Systems Benzodiazepine Reagent Device Name:
Indications for Use:
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines 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 laver chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
Clinical consideration and professional judgment 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (per 21 CFR 801.109)
Over-the-Counter Use Optional Format 1-2-96
Alan Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .
Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Benzodiazepine Reagent File: BENZ s510k.doc 9/02