(66 days)
Not Found
No
The document describes a calibrator for a laboratory test system, which is a chemical reagent used for calibration, not a software or imaging device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a calibrator used for testing HDL Cholesterol, not for treating a condition or disease.
No
This device is described as a "calibrator," which is used to calibrate HDL Cholesterol test systems. It is not directly used for diagnosing a patient condition but rather to ensure the accuracy of diagnostic instruments.
No
The device description clearly states it is a "human serum-based liquid calibrator set," indicating it is a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of HDL Cholesterol test systems" on Beckman's SYNCHRON Systems. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: It's a "human serum-based liquid calibrator set." Calibrators are used to establish a known relationship between the signal measured by an instrument and the concentration of an analyte in a sample, which is a fundamental aspect of in vitro diagnostics.
- Context: The device is used "in conjunction with SYNCHRON® HDL Cholesterol reagent," which is clearly an in vitro diagnostic reagent used to measure HDL Cholesterol in biological samples.
The information provided strongly indicates that this device is intended to be used outside of the body to calibrate a system that performs diagnostic tests on biological samples, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems Lipid Calibrator, used in conjunction with SYNCHRON® HDL Cholesterol reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of HDL Cholesterol test systems.
Product codes
75 JIS
Device Description
The SYNCHRON Systems Lipid Calibrator Set is a two level ready-to-use human serumbased liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 3 X 2 mL bottles of a specific level of calibrator (identified as Level 1 and Level 2). Once opened, the calibrators are stable for 65 days when stored at +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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stress stability and open bottle stability studies of the lipid calibrator support the Beckman stability claim of 24 months and 65 days for open bottles.
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
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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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DEC 2 1 1998
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling a black oval with two curved white lines running through it. To the right of the symbol, the words "BECKMAN" are stacked above the word "COULTER" in a bold, sans-serif font.
Summary of Safety & Effectiveness SYNCHRON® Systems Lipid Calibrator
1.0 Submitted By:
Lucinda Stockert Staff Requlatory 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 15, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Lipid Calibrator
3.2 Classification Name
Calibrator, (21 CFR §862.1150)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------|---------------------------------|-----------------------|------------------|
| SYNCHRON® Systems
Lipid Calibrator | Beckman™ VIGIL Lipid
Control | Beckman Coulter, Inc. | K974452 |
5.0 Description:
The SYNCHRON Systems Lipid Calibrator Set is a two level ready-to-use human serumbased liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 3 X 2 mL bottles of a specific level of calibrator (identified as Level 1 and Level 2). Once opened, the calibrators are stable for 65 days when stored at +2℃ to +8℃.
1
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Lipid Calibrator Summary of Safety & Effectiveness
5.0 Intended Use:
The SYNCHRON® Systems Lipid Calibrator is intended for use with the SYNCHRON Systems for the calibration of direct HDL Cholesterol reagent.
7.0 Comparison to Predicate(s):
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON | ||
| Systems Lipid | ||
| Calibrator | Source Material: Defibrinated human plasma | |
| spiked with human lipids and stabilized by | ||
| freezing. | Same as Beckman™ | |
| VIGIL Lipid Control | ||
| Storage Temperature (-15°C to -20°C) | ||
| Liquid, ready-to-use form | ||
| Value Assignment Methodology |
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON | ||
| Systems Lipid | ||
| Calibrator | Intended Use: | SYNCHRON Systems Lipid Calibrator is |
| intended for use in calibration of | ||
| SYNCHRON Systems HDL Cholesterol | ||
| Reagent. | ||
| Beckman™ VIGIL Lipid Control is | ||
| intended for use in monitoring the | ||
| reliability of automated in vitro diagnostic | ||
| assays of HDL Cholesterol. | ||
| Analytes | SYNCHRON Systems Lipid Calibrator | |
| contains HDL Cholesterol. | ||
| Beckman™ VIGIL Lipid Control contains | ||
| cholesterol, HDL cholesterol, | ||
| triglycerides, apolipoprotein A-1, | ||
| apolipoprotein B. | ||
| Levels of Analyte | SYNCHRON Systems Lipid Calibrator: | |
| 2 levels | ||
| Beckman™ VIGIL Lipid Control: 4 levels |
Differences from the Predicate
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stress stability and open bottle stability studies of the lipid calibrator support the Beckman stability claim of 24 months and 65 days for open bottles.
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.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair and facial features. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top half of the design.
DEC 2 1 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, CA 92822-8000
Re: K983640 Trade Name: SYNCHRON® Systems Lipid Calibrator Regulatory Class: II Product Code: 75 JIS October 15, 1998 Dated: October 16, 1998 Received:
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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: 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
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 requlation 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 Putman
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 of
510(k) Number (if known): K 9836 40
Device Name: SYNCHRON® Systems Lipid Calibrator
Indications for Use:
The SYNCHRON® Systems Lipid Calibrator, used in conjunction with SYNCHRON® HDL Cholesterol reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of HDL Cholesterol test systems.
Clinical Significance:
A 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.
(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
vision of Clinical Laboratory Devices 510(k) Number