(59 days)
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Not Found
No
The summary describes a standard in vitro diagnostic assay for HDL Cholesterol, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No.
The device is used for in vitro diagnostic (IVD) determination of HDL Cholesterol, which aids in the diagnosis and treatment of disorders, but it does not directly treat or prevent a disease in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used in the diagnosis and treatment of disorders involving low HDL Cholesterol."
No
The intended use describes a quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers, which implies a physical assay and hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum". "In Vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "human serum," which is a biological sample taken from the body.
- Purpose: The measurements are used "in the diagnosis and treatment of disorders," which is the primary purpose of IVDs – to provide information for medical decisions.
- Method: The determination is quantitative, meaning it measures the amount of HDL Cholesterol, which is a common function of IVDs.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers.
HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
Product codes
LBS, JIX, JJX
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Public Health Service
Food and Drug Administration 2098 Gaither Road Rackville MD 20850
JUL 1 9 2002
Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166
Re: K021671
Trade/Device Name: HDL Cholesterol (Automated) REAGENT Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system; Regulatory Class: Class II Product Code: LBS: JIX; JJX Dated: May 1, 2002 Received: May 21, 2002
Dear Mr. Johnston:
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/cdrb/dsmaldsmamain.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): | N/A K021671 |
|---|---|
| Device Name: | HDL Cholesterol (Automated) REAGENT |
| Indications for Use: |
Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers.
HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
lan
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021671
(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)