(25 days)
SYNCHRON CX (CX4/4CE/4A/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO, LX20/PRO, and UniCel DxC 600/800 Systems
No
The summary describes a reagent kit for a chemical assay and does not mention any AI or ML components.
No.
This device is a reagent used for diagnostic testing to detect benzodiazepines in urine, not to treat a condition.
Yes
The device is described as providing a "qualitative determination of benzodiazepines in human urine" and a "rapid screening procedure for determining the presence of benzodiazepines in urine," which are functions of a diagnostic device. It also states that "a positive result by this assay should be confirmed by another generally accepted non-immunological method," implying its role in initial diagnosis or screening.
No
The device description clearly states it is a "reagent kit" and a "cartridge," which are physical components, not software.
Based on the provided information, 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 classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide diagnostic information (presence of benzodiazepines).
- Device Description: The description mentions it's a "reagent" designed for use on "SYNCHRON Systems," which are laboratory analyzers. This further supports its use in a clinical laboratory setting for diagnostic testing.
- Context: The entire document is structured like a typical submission for an IVD device, including sections like "Intended Use," "Device Description," and "Predicate Device(s)."
The fact that it's a "reagent" used to test a biological sample (urine) for the presence of a substance (benzodiazepines) outside of the body clearly places it within the definition of an In Vitro Diagnostic device.
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 (oxazepam), 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/4A/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO, LX20/PRO, and UniCel DxC 600/800 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
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies
Performance data from validation testing supports equivalency.
Key Metrics
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
JUN 1 3 2005
510(k) SUMMARY
051307
1.0 Submitted By:
Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123
Date Submitted 2.0
May 18, 2005
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 K023048)
5.0 Device Description
The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO, LX20/PRO, and UniCel DxC 600/800 Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.
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K051307
page 2 of 2
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 ng/mL (oxazepam), 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
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central image.
JUN 1 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000
K051307 Re: -Trade/Device Name: SYNCHRON® Systems Benzodiazepine Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: May 18, 2005 Received: May 19, 2005
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, 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).
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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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology 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 Benzodiazepine Reagent Device Name:
Indications for Use:
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Denzoulazepine (DAT) Urine Calibrators, is intended for the qualitative Drugs of Abuso Tooting (D. of human urine at a cutoff value of 200 ng/mL, (oxazepam) on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining I he Bonzodiazepines adjazepines in urine. This test provides only a preliminary the probentive result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin laver gonomatography (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.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR -
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Bute a chule
Page 1 of
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051307
Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Benzodiazepine Reagent File: BENZ 2005 s510k.doc, 5/05