(133 days)
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No
The document describes a reagent and calibrator for a laboratory system, with no mention of AI or ML technology in its intended use or description.
No
The device is described as a reagent and calibrator used for quantitative determination of HDL cholesterol in human serum or plasma. It is intended for diagnostic purposes (measuring lipoprotein) rather than for treating a disease or condition.
Yes
The document states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases," indicating its use in diagnosing medical conditions.
No
The summary describes a reagent and calibrator for use with a specific hardware system (UniCel DxC 600/800 SYNCHRON System(s)). It does not describe a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the reagent and calibrator are for the "quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma." This involves testing biological samples (serum or plasma) outside of the body.
- Purpose of Measurement: The description of a lipoprotein test system clarifies that these measurements are "used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases." This directly relates the test results to medical diagnosis and treatment decisions.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
Calibrator: The UniCel DxC SYNCHRON Systems HDL Calibrator is designed to provide suitable calibration levels for Beckman Coulter UniCel DxC 600/800 SYNCHRON Systems employing the quantitative UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL).
Product codes
JIT, LBS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The symbol is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
BECKMAN COULTER, INC. C/O EIMEAR CARR REGULATORY AFFAIRS SPECIALIST 250 S. KREAMER BOULEVARD BREA CA 92821
Re: K142985
Trade/Device Name: UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent (HDL) Unicel Dxc SYNCHRON Systems HDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, LBS Dated: January 23, 2015 Received: January 27, 2015
Dear Eimear Carr:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -A
For :Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL) UniCel DxC SYNCHRON Systems HDL Calibrator
Indications for Use (Describe)
Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
Calibrator: The UniCel DxC SYNCHRON Systems HDL Calibrator is designed to provide suitable calibration levels for Beckman Coulter UniCel DxC 600/800 SYNCHRON Systems employing the quantitative UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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