(68 days)
Not Found
No
The document describes calibrators for laboratory tests and does not mention any AI or ML components.
No.
This device is a calibrator used for in-vitro diagnostic tests, not for directly treating a disease or condition.
No
This device is a calibrator used for enzyme immunoassays, not a diagnostic device itself. Its purpose is to calibrate other diagnostic tests (reagents) that detect drugs of abuse.
No
The device description clearly states it is a physical product containing liquid calibrators in bottles, requiring storage at a specific temperature. This indicates it is a hardware/reagent-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the calibrators are used "in conjunction with SYNCHRON Reagents... for the calibrations of Barbiturates, Benzodiazepine, Methadone, Opiate 300 ng, Methaqualone, and Propoxyphene enzyme immunoassays." These are tests performed in vitro (outside the body) on biological samples (urine) to detect the presence and/or concentration of specific substances.
- Device Description: The description mentions the product is used for "calibration of Drugs of Abuse reagents in the clinical laboratory." Clinical laboratories perform in vitro diagnostic testing.
- Predicate Device: The predicate device listed (K935101; Drugs of Abuse Urine Calibrators A) is also an IVD, indicating that this type of product falls under the IVD category.
The device is a calibrator, which is a type of IVD accessory used to ensure the accuracy of IVD tests.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems DAT Low and High Urine Calibrators II, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Barbiturates, Benzodiazepine, Methadone, Opiate 300 ng, Methaqualone, and Propoxyphene enzyme immunoassays.
Product codes
DKB
Device Description
The SYNCHRON® Systems DAT Low and High Urine Calibrators II are used for calibration of Drugs of Abuse reagents in the clinical laboratory. This product contains a 5 mL bottle of the Low Urine Calibrator II and a 5 mL bottle of the High Urine Calibrator 11. The storage temperature for the calibrators is +2℃ to +8℃.
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
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 Urine Calibrators II support the Beckman stability claim of 12 months.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
DEC 30 1998
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized graphic to the left of the company name. The graphic is a black oval shape with two curved white lines running through it. The text "BECKMAN" is above the text "COULTER".
Summary of Safety & Effectiveness SYNCHRON® Systems DAT Low and High Urine Calibrators II
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 21, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems DAT Low and High Urine Calibrators II
3.2 Classification Name
Clinical Toxicology Calibrator (21 CFR §862.3200)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------------------------------|---------------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems
DAT Low and High
Urine Calibrators II | Drugs of Abuse Urine
Calibrators A | Diagnostic Reagents,
Inc.* | K935101 |
*Diagnostic Reagents, Inc. Sunnyvale, CA
5.0 Description:
The SYNCHRON® Systems DAT Low and High Urine Calibrators II are used for calibration of Drugs of Abuse reagents in the clinical laboratory. This product contains a 5 mL bottle of the Low Urine Calibrator II and a 5 mL bottle of the High Urine Calibrator 11. The storage temperature for the calibrators is +2℃ to +8℃.
Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com
1
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Low and High Urine Calibrators II Summary of Safety & Effectiveness
5.0 Intended Use:
g
The SYNCHRON® Systems DAT Low and High Urine Calibrators II, in coniunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Barbiturates, Benzodiazepine, Methadone, Opiate 300 ng, Methaqualone, and Propoxyphene enzyme immunoassays.
7.0 Comparison to Predicate(s):
Identical to predicate product (labeled for Beckman Coulter, Inc.) with the addition of the 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 Urine Calibrators II 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines, and the overall design is simple and modern.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 30 1998
Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 Brea, CA 92822
Re: K983747
Trade Name: SYNCHRON® Systems DAT Low and High Urine Calibrators II Regulatory Class: II Product Code: DKB Dated: October 21, 1998 Received: October 23, 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 vour 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 (OS) 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 DAT Low and High Urine Calibrators II
Indications for Use:
The SYNCHRON® Systems DAT Low and High Urine Calibrators II, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Barbiturates, Benzodiazepine, Methadone, Opiate 300 ng. Methaqualone, and Propoxyphene enzyme immunoassays.
21 CFR 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.
(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)
Patricia Berlarct
(Division Sign-Off)
Division of Clinical Laboratory Devices
K983747
510(k) Numc
Prescription Use
OR
Over-the-Counter Use
(per 21 CFR 801.109)
Optional Format 1-2-96