(51 days)
N/A
N/A
No
The document describes calibrators for laboratory tests and does not mention any AI or ML components or functionalities.
No
The device is a calibrator for in vitro diagnostic tests, not a device used to treat or cure a disease or condition in a patient.
No
This device is a calibrator, used to calibrate other diagnostic devices (enzyme immunoassays), not a diagnostic device itself.
No
The device is described as "Urine Calibrators," which are physical substances used for calibration, not software. The description focuses on their use with SYNCHRON Systems and enzyme immunoassays, implying a hardware and chemical component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are used "in conjunction with SYNCHRON Reagents... for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays." These are tests performed on biological samples (urine) outside of the body to provide information about a person's health status (specifically, the presence of certain drugs). This aligns with the definition of an in vitro diagnostic.
- Device Description: The description further clarifies that the calibrators are "used for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassay on Beckman SYNCHRON® Systems." This reinforces their role in a diagnostic testing process.
- Predicate Device: The mention of a "Predicate Device(s)" with the name "Drugs of Abuse Urine Calibrators" (K920208) strongly indicates that this device is being compared to other legally marketed IVDs.
The information provided clearly demonstrates that this device is intended to be used in a laboratory setting to calibrate instruments that perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.
Device Description
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1 are used for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassay on Beckman 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 toxicology calibrators already in commercial distribution. Stress stability studies of the DAT Low and High Unine Calibrators 1 support the Beckman stability claim of 18 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s) (K number(s) and name(s); separate multiples with ";")
K920208; Drugs of Abuse Urine Calibrators
Reference Device(s) (K number(s) and name(s); separate multiples with ";")
Not Found
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.
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:
Image /page/0/Picture/1 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 leaf or wave. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font. The overall design is clean and modern, conveying a sense of professionalism and innovation.
Summary of Safety & Effectiveness SYNCHRON® Systems DAT Low and High Urine Calibrators 1
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:
October 20, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems DAT Low and High Urine Calibrators 1
3.2 Classification Name
Calibrator, Drug Mixture (21 CFR §862.3200)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|-----------------------------------------------------------|-------------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems
DAT Low and High
Urine Controls 1 | Drugs of Abuse Urine
Calibrators | Diagnostic Reagents,
Inc.* | K920208 |
*Diagnostic Reagents, Inc. Sunnyvale, CA
5.0 Description:
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1 are used for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassay on Beckman SYNCHRON® Systems.
1
5.0 Intended Use:
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.
7.0 Comparison to Predicate(s):
Identical to predicate product with Beckman Coulter, Inc. label and increased level of Opiate analyte.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to toxicology calibrators already in commercial distribution. Stress stability studies of the DAT Low and High Unine Calibrators 1 support the Beckman stability claim of 18 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/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal features a stylized image of an eagle with its wings spread, with three human figures underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
NOV 4 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea. California 92822-8000
Re: K983209
Trade Name: SYNCHRON Systems DAT and High Urine Calibrators 1 Regulatory Class: II Product Code: DKB Dated: September 10, 1998 Received: September 14, 1998
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 OS 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 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 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
A. L.
4
page _____ of ________________________________________________________________________________________________________________________________________________________________
1983209
510(k) Number (if known): Not yet assigned
Device Name: SYNCHRON® Systems DAT Low and High Urine Calibrators 1
Indications for Use:
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.
21 CFR 862.3200 Calibrators, Drug Mixture
(a) Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug.
(b) Classification. Class II.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K983209 |
|---|---|
| --------------- | --------- |
| Prescription Use
(per 21 CFR 801.109)
✓ | OR | Over-the-Counter Use
Optional Format 1-2-96 |
| ---------------------------------------------------------- | ---- | ------------------------------------------------ |
|---|