(27 days)
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No
The summary describes a chemical reagent for measuring LDL cholesterol and contains no mention of AI or ML.
No
This device is a reagent for measuring LDL Cholesterol levels, which is used for diagnosis and risk assessment, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the results are "used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease." This indicates its role in diagnosing medical conditions.
No
The device is described as a "reagent" and "reagent" is a chemical substance used in a chemical reaction, indicating it is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagent is for the "quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples." This indicates that the device is used to test samples taken from the human body.
- Clinical Application: The intended use also specifies that the results are used in the "diagnosis and treatment of lipid disorders... atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease." This demonstrates that the test results are used for medical purposes related to diagnosis, treatment, and risk assessment.
- Sample Type: The device is designed to be used with "serum or plasma samples," which are biological specimens taken from a human.
These characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the compatibility of a transplant.
N/A
Intended Use / Indications for Use
This reagent is intended for the quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples. LDL-Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
Product codes (comma separated list FDA assigned to the subject device)
MRR
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
SEP 1 7 2002
Mr. Jose A. Montanez Official Correspondent Corporate Director Ouality Assurance & Regulatory Affairs Hemagen Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045
Re: K022772
Trade/Device Name: RAICHEM® LDL - Cholesterol Direct Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Low density lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: August 19, 2002 Received: August 21, 2002
Dear Mr. Montanez:
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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrlvdsma/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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510(k) Number (if known): K022772
Device Name: RAICHEM® LDL – Cholesterol Direct Reagent
Indications For Use:
This reagent is intended for the quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples. LDL-Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number_
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
(Optional Format I-2-96)