(257 days)
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No
The provided text describes a device for quantitative measurement of triglycerides and total cholesterol in serum, which are standard laboratory tests. 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 the intended use and indications for use, which are purely analytical measurements.
No.
The device is for in-vitro diagnostic use, specifically for measuring triglycerides and total cholesterol in serum, which are diagnostic tests and not therapeutic interventions.
Yes
The device is described as being used in the "diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders" and "diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders." These phrases explicitly indicate its use for diagnostic purposes.
No
The provided text describes an in-vitro diagnostic device for measuring triglycerides and cholesterol in serum. This type of device typically involves hardware components for sample analysis, and the summary does not mention it being software-only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "quantitative measurement of triglycerides in serum" and "quantitative measurement of Total cholesterol in serum." These measurements are performed on biological samples (serum) taken from the body.
- Purpose: The measurements are used "in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders" and "in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders." This clearly indicates a diagnostic purpose.
- "For in-vitro use only": This phrase is a strong indicator that the device is intended for use outside of the living body, which is the definition of "in vitro."
While other sections like "Device Description," "Mentions image processing," etc., are "Not Found," the core information in the "Intended Use" section is sufficient to classify this device as an IVD.
N/A
Intended Use / Indications for Use
For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only.
For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.
Product codes
CHH, CDT
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
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Key Metrics
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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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§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with stylized lines representing its wings and body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 7 2008
JAS Diagnostics, Inc. c/o Mr. Samuel Burgos Quality Assurance Manager 7220 NW 58th Street Miami, FL 33166
K080623 Re:
Trade Name: Cholesterol Oxidase JAS; Glycerol Kinase Triglycerides Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) Test System Regulatory Class: Class I, subject to the limitation to exemption in 21 CFR 862.9(c)(4) Product Codes: CHH, CDT Dated: October 16, 2008 Received: October 23, 2008
Dear Mr. Burgos:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli the (800) 638-2041 or (240) 276-3150 or at its Internet consumer http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K080623
Device Name: Triglycerides
Indication For Use:
For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only.
V Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Digital Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090623
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Indication for Use
510(k) Number (if known): K080623
Device Name: Cholesterol Oxidase
Indication For Use:
For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.
V Prescription Use _ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080623