(43 days)
The Beckman Coulter Drug Calibrator 2 is a six-level calibrator intended for use on the SYNCHRON CX Systems and LX20 Systems for the calibration of digoxin and acetaminophen.
The SYNCHRON® Systems Drug Calibrator 2 is intended for use on SYNCHRON Systems for the calibration of digoxin and acetaminophen. This product contains a 2.0 mL bottle each of Levels 1 to 6 of Drug Calibrator 2. The storage temperature for the calibrator is +2℃ to +8℃.
The provided text is a summary of safety and effectiveness for a medical device (SYNCHRON® Systems Drug Calibrator 2) submitted to the FDA. It does not contain detailed information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document focuses on:
- Identification of the device and manufacturer.
- Intended use of the device: Calibration of digoxin and acetaminophen on SYNCHRON CX Systems and LX20 Systems.
- Comparison to a predicate device: Highlighting that the digoxin level is identical and both use human serum with weighed-in quantities of digoxin. The main difference noted is the new product contains acetaminophen analyte.
- Regulatory information: Classification, predicate device, and the FDA's letter of substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria and a study from the given text. There are no tables of acceptance criteria, reported device performance data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance details, or information about training sets or ground truth establishment.
The "Summary of Performance Data" section is extremely brief and only states, "The new Drug Calibrator 2 product contains acetaminophen analyte." This is not a summary of performance data in the context of meeting acceptance criteria.
{0}------------------------------------------------
NOV 26 1999
Image /page/0/Picture/2 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 eye. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font.
Summary of Safety and Effectiveness SYNCHRON® Systems Drug Calibrator 2
1.0 Submitted By:
Gail Lefebvre Associate Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8503 FAX: (714) 961-4123
2.0 . Date Submitted:
October 13, 1999
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Drug Calibrator 2
Classification Name 3.2
Clinical Toxicology Calibrator (21 CFR § 862.3200)
4.0 Predicate Device(s):
| SYNCHRON SystemsReagent | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| SYNCHRON® SystemsDrug Calibrator 2 | SYNCHRON® DrugCalibrator 2 | Beckman Coulter, Inc. | K982935 |
5.0 Description:
The SYNCHRON® Systems Drug Calibrator 2 is intended for use on SYNCHRON Systems for the calibration of digoxin and acetaminophen. This product contains a 2.0 mL bottle each of Levels 1 to 6 of Drug Calibrator 2. The storage temperature for the calibrator is +2℃ to +8℃.
Beckman Coulter, Inc. 200 S. Kraemer Boulevard Brea, CA 92821
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com
{1}------------------------------------------------
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Drug Calibrator 2 Summary of Safety and Effectiveness
6.0 intended Use:
.
The Beckman Coulter Drug Calibrator 2 is a six-level calibrator intended for use on the SYNCHRON CX Systems and LX20 Systems for the calibration of digoxin and acetaminophen.
Comparison to Predicate(s): 7.0
The digoxin level between the two products is identical. Both the candidate and the predicate are made from human serum to which weighed-in quantities of digoxin analyte are added.
Summary of Performance Data: 8.0
The new Drug Calibrator 2 product contains acetaminophen analyte.
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 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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 1999
Ms. Gail Lefebvre Associate Regulatory Specialist Beckman Coulter Inc. 200 S. Kraemer Boulevard Brea, California 92821
Re: K993473
Trade Name: SYNCHRON® Systems Drug Calibrator 2 Regulatory Class: II Product Code: DLJ Dated: October 13, 1999 Received: October 14, 1999
Dear Ms. Lefebvre:
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 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 (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: SYNCHRON® Systems Drug Calibrator 2
Indications for Use:
The Beckman Coulter Drug Calibrator 2 is a six-level calibrator intended for use on the SYNCHRON CX Systems and LX20 Systems for the calibration of digoxin and acetaminophen.
Clinical Significance:
The Drug Calibrator 2 utilizes processed human serum to which weighed-in drug quantities are added. The calibrator set is designed for generation of a sixpoint calibration curve which defines the analytical range for digoxin and acetaminophen.
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k 993493
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
§ 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.