(65 days)
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No
The 510(k) summary describes a standard clinical chemistry test system for measuring HDL cholesterol. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on reagents, calibrators, controls, and their use on clinical chemistry analyzers.
No.
The device is for in vitro diagnostic (IVD) use to quantify HDL cholesterol, which aids in assessing coronary artery disease risk, but it does not directly treat or prevent a disease.
Yes
The device is described as a "Test System" for the "quantitative determination of HDL Cholesterol concentrations in human serum and plasma." This determination is explicitly stated to be "used in the initial screening for hypercholesterolemia," indicating its role in identifying a health condition.
No
The device description clearly indicates it is a "Test System" containing reagents, calibrators, and control materials intended for use on "Clinical Chemistry Analyzers." These are physical components and hardware, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "quantitative determination of HDL Cholesterol concentrations in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Components: The system includes reagents, calibrators, and control materials, which are typical components of IVD test systems used to analyze biological samples.
- Purpose: The purpose is to measure a specific analyte (HDL Cholesterol) in a biological fluid (serum and plasma) to provide information for medical purposes (assessing risk of coronary artery disease).
The description aligns perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma.
The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in calibration of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera are designed to monitor the recovery and precision of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia.
Product codes
LBS, JIT, JIX
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1475 Lipoprotein test system.
(a)
Identification. 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 (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three abstract human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 8 2002
Mr. Michael Campbell Manager, Regulatory Affairs/Quality Assurance Olympus America Inc Diagnostic Systems Group 3131West Royal Lane Irving Texas 75063-3104
K014015 Re:
Trade/Device Name: Olympus HDL Cholesterol Test System Regulation Number: 21 CFR 862.1475; 21 CFR 862.1150; 21 CFR 862.1660 Regulation Name: Lipoprotein test system; Calibrator; Quality control material (assayed or unassayed) Regulatory Class: Class I; Class II; Class I (reserved) Product Code: LBS; JIT; JIX Dated: January 18, 2002 Received: January 22, 2002
Dear Mr. Campbell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 Part 801); 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.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you of substantial equivalence of your device to a legally marketed nouticate 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 1 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, (201) 594-1500. Treatures of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small nuonnation on your respond and Consumer 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
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Indications for Use Statement
510(k) Number (if known):
Device Name:
Olympus HDL Cholesterol Test System Contents: Olympus HDL Cholesterol Reagent Olympus HDL Cholesterol Calibrator Olympus HDL/LDL Cholesterol Control
Indications for Use:
The Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma.
The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in calibration of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera are designed to monitor the recovery and precision of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia.
Ha
(Division Sign-Off)
Division of Clinical Laborat
510(k) Number K014015
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--------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) V OR Over-The-Counter Use Prescription Use (per 21 CFR 801.109) (Optional Format 1-2-96)