(170 days)
Not Found
No
The description focuses on a chemical assay using reagents and calibrators to measure HDL cholesterol. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies. The performance studies are standard analytical chemistry evaluations.
No
The device is a diagnostic testing system that measures HDL-C levels, which aids in the diagnosis and treatment of disorders, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states, "HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders," indicating its role in diagnosis.
No
The device description clearly states it is a "system using the reagent and calibrator in combination" and describes a chemical reaction process, indicating it is a hardware/reagent-based in vitro diagnostic device, not software-only.
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 determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma." This is a test performed on biological samples taken from the body.
- Device Description: The description details a "system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol." This involves chemical reactions with the sample, which is characteristic of in vitro diagnostics.
- Intended User / Care Setting: The statement "For In Vitro Diagnostic Use Only" directly confirms its classification as an IVD.
N/A
Intended Use / Indications for Use
Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
Product codes (comma separated list FDA assigned to the subject device)
LBS; JIX
Device Description
The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalency was demonstrated by method comparison. Correlation study was performed between Direct HDL-Cholesterol Liquid Color®, calibrated with Direct HDL/LDL -Cholesterol Calibrator (Stanbio ) and HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche) using 50 patient samples. A correlation coefficient of 0.9987 and a regression equation of y = 1.01x -0.4942 was obtained. Also, precision, linearity, sensitivity and interference studies were performed on Stanbio Direct HDL-Cholesterol Liquid Color . Results of these tests were within acceptable range. The result of HDL-cholesterol using Stanbio Direct HDL-Cholesterol Liquid Color is linear to 200mg/dl. For the analytical sensitivity, a change of 0.001 absorbance units is equivalent to approximately 0.4mg/dl of HDL Cholesterol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
MAR 1 0 2004
510(k) SUMMARY
1032932
| Submitter's Name and Address: |
|---|
| ------------------------------- |
| Stanbio Laboratory. | Phone: (830) 249-0772 |
|---|---|
| 1261 North Main Street | Fax: (830) 249-0851 |
| Boerne, Texas 78006 | e-mail: AOguchi@stanbio.com |
| Prepared By: | Adaobi Oguchi |
|---|---|
| September 12, 2003 |
| Product Name | |
|---|---|
| Trade name: | Direct HDL-Cholesterol Liquid Color® ; Direct |
| HDL/LDL-Cholesterol Calibrator. | |
| Common name: | Lipoprotein test system; Calibrator |
| Classification name: | LDL & VLDL precipitation, cholesterol via Esterase- |
| Oxidase, HDL; Calibrator. | |
| Class: | I;II |
| Product Code: | LBS; JIX |
| Manufacture: | Stanbio Laboratory, |
| 1261 North Main Street | |
| Boerne, Texas 78006 |
The establishment Registration No. is 1616487.
Substantial Equivalence of Device
The Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system (Stanbio) is substantially equivalent to HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
Description of Device
The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol.
This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps.
It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed.
1
510(k) SUMMARY CONT'D
K032932
page 2 of 2
The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.
Indications for use:
Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
Performance Data
Substantial equivalency was demonstrated by method comparison. Correlation study was performed between Direct HDL-Cholesterol Liquid Color®, calibrated with Direct HDL/LDL -Cholesterol Calibrator (Stanbio ) and HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche) using 50 patient samples. A correlation coefficient of 0.9987 and a regression equation of y = 1.01x -0.4942 was obtained.
Also, precision, linearity, sensitivity and interference studies were performed on Stanbio Direct HDL-Cholesterol Liquid Color . Results of these tests were within acceptable range.
The result of HDL-cholesterol using Stanbio Direct HDL-Cholesterol Liquid Color is linear to 200mg/dl.
For the analytical sensitivity, a change of 0.001 absorbance units is equivalent to approximately 0.4mg/dl of HDL Cholesterol.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services 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 graphic of three wavy lines, which are likely meant to represent a flag or banner.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 0 2004
Ms. Adaobi Oguchi Ouality Control Manager Stanbio Laboratory 1261 North Main Street Boerne, TX 78006
K032932 Re:
Trade/Device Name: Stanbio Laboratory Direct HDL Cholesterol LiquiColor® and Stanbio Direct HDL/LDL Cholesterol Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX; LBS Dated: December 18, 2003 Received: December 22, 2003
Dear Ms. Oguchi:
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).
3
Page 2
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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,
Jean M. Cooper MS, DVM.
Yean M. Cooper, MS, 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
4
X232932 510(k) Number (if known): ____________________
Stanbio Laboratory Direct HDL Cholesterol LiquiColor® and Stanbio Direct Device Name: HDL/LDL Cholesterol Calibrator
Indications for use:
Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma.
HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
. *
For In Vitro Diagnostic Use Only.
(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 CFR801.109)
OR
Over the Counter Use
Carol Benson
ivision Slan-O
Office of In Vitro Diagn Device Evaluation and
510(k) K032932