(122 days)
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Not Found
No
The summary describes image analysis software but does not mention AI, ML, or related terms.
No
The device measures lipoprotein cholesterol to aid in evaluating lipid metabolism disorders; it does not treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section states that "Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders," which is a diagnostic purpose.
Yes
The device description explicitly states it is an "analysis software capability" used in conjunction with commercially available hardware (computer, scanner, printer) to analyze scanned images. It does not include or modify the hardware itself.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure lipoprotein cholesterol... in fasting serum or plasma." This involves testing biological samples (serum or plasma) outside of the body to obtain information about a patient's health status (lipid metabolism disorders).
- Purpose: The measurements are used "as an aid in evaluating lipid metabolism disorders," which is a diagnostic purpose.
- Device Description: The device analyzes "scanned tube images" of samples that have undergone a process to resolve lipoprotein fractions and subfractions. This process is performed on the biological sample.
These characteristics align 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 Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein The Quantinents upopini " -yylent LDE Babileanon or plasma with a Total Choleserol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.
Product codes
JHO
Device Description
Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions weriley weiled Quandinena 11 Implementing an the Jip Software sphication is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and general and color of the lovel the lovel the lovel the naracterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, HDL), The level of Indiations of the device modification was determined to be "moderate". This level of concern is for the software only. The . It he ded use of the modified device remains the same as that of the unmodified device.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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
8 2002 MAR
5. ATTACHMENTS
SPECIAL 510(k) SUMMARY ATTACHMENT A.
This summary of Special 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| 510(k) Number: | K013662 |
|---|---|
| Proprietary Name: | LipoPrint™ System LDL Subfractions |
| Common Name: | LipoPrint Test System (Electrophoresis) |
| Classification Name: | Electrophoretic Separation, Lipoproteins |
| Manufacturer: | Quantimetrix Corporation |
| 2005 Manhattan Beach Boulevard | |
| Redondo Beach, CA 90278 | |
| Phone 310-536-0006 Fax 310-536-9977 | |
| Contact Person: | Never Gebhard, Ph.D. Director Of R&D 310-536-0006 Ext. 135 |
Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions weriley weiled Quandinena 11 Implementing an the Jip Software sphication is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and general and color of the lovel the lovel the lovel the naracterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, HDL), The level of Indiations of the device modification was determined to be "moderate". This level of concern is for the software only. The . It he ded use of the modified device remains the same as that of the unmodified device.
INTENDED USE AND INDICATIONS FOR USE:
The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein The Quantinents upopini " -yylent LDE Babileanon or plasma with a Total Choleserol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 8 2002
Gebhard Neyer, Ph.D. Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278-1205
K013662 Re:
Trade/Device Name: LipoPrint™ System LDL Subfractions Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: JHO Dated: February 12, 2002 Received: February 19, 2002
Dear Dr. Neyer:
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.
2
Page 2 -
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 noutication. The I Dr in 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 additionally 60710 dditionally, for questions on the promotion and advertising of your device, (201) 594-1500. Traditions 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 mionination on your responsiver Assistance at its toll-free number (800) 638-2041 or Manufacturers internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
3
5. ATTACHMENTS
INDICATIONS FOR USE FORM ATTACHMENT E.
510(K) NUMBER (IF KNOWN):
LipoPrint™ System LDL Subfractions
DEVICE NAME:
013662
INTENDED USE AND INDICATIONS FOR USE:
The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure inpoprotection in and expressions The Quantinetix "Lipoprifi" " yylen" "DE "Burneer"). in fasting serum or plasma with a Total Cholesterol concentration ilpoproven nactions and subliacions from 125 a very an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.
Kwon
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number