(172 days)
Not Found
No
The device description focuses on a chemical reaction and enzymatic process for measuring LDL-C, with no mention of AI or ML. The performance studies are standard analytical chemistry evaluations.
No.
The device is described as a "testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma" and is "For In Vitro Diagnostic Use Only," indicating it's used for diagnosis and not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states that the device "aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders." This indicates its role in the diagnostic process.
No
The device description clearly states it is a "system using the reagent and calibrator in combination" and describes a chemical reaction process involving "reagent" and "enzymes." This indicates the device is a chemical assay system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "For In Vitro Diagnostic Use Only." It also describes the device as a "testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma," which is a classic definition of an in vitro diagnostic test.
- Device Description: The description details a system using reagents and calibrators to analyze a biological sample (serum or plasma) outside of the body. This is the core concept of in vitro diagnostics.
- Purpose: The intended use states that the measurement "aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders," indicating a medical purpose for the test results.
N/A
Intended Use / Indications for Use
Direct LDL Chollesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of lowdensity lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
For In Vitro Diagnostic Use Only.
Product codes (comma separated list FDA assigned to the subject device)
MRK, LBS, JIX
Device Description
The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-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 HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then react with the LDLcholesterol 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 LDL-Cholesterol Liquid Color , calibrated with Direct HDL/LDL -Cholesterol Calibrator (Stanbio) and LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche) using 62 patient samples. A correlation coefficient of 0.9969 and a regression equation of y = 1.025x - 4.0289 was obtained. Also, precision, linearity, sensitivity and interference studies were performed on Stanbio Direct LDL-Cholesterol Liquid Color . Results of these tests were within acceptable range. The result of LDL-cholesterol using Stanbio Direct LDL-Cholesterol Liquid Color is linear to 700mg/dl. For the analytical sensitivity, a change of 0.001 absorbance units is equivalent to approximately 0.4mg/dl of LDL Cholesterol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient: 0.9969
Regression equation: y = 1.025x - 4.0289
Linearity: 700 mg/dl
Analytical sensitivity: 0.001 absorbance units is equivalent to approximately 0.4mg/dl of LDL Cholesterol.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
MAR 1 2 2004
page 182
510(k) SUMMARY
Submitter's Name and Address: Phone: (830) 249-0772 Stanbio Laboratory Fax: (830) 249-0851 1261 North Main Street e-mail: AOguchi@stanbio.com Boerne, Texas 78006
Prepared By: Adaobi Oguchi September 12, 2003
| Product Name
Trade name: | Direct LDL-Cholesterol Liquid Color®; Direct
HDL/LDL-Cholesterol Calibrator. |
|-----------------------------|---------------------------------------------------------------------------------|
| Common name: | LDL-Cholesterol; Calibrator |
| Classification name: | Lipoprotein test system; Calibrator. |
| Class: | 1;II |
| Product Code: | MRK
LBS, JIX |
| Manufacture: | Stanbio Laboratory,
1261 North Main Street
Boerne, Texas 78006 |
The establishment Registration No. is 1616487.
Substantial Equivalence of Device
The Direct LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system (Stanbio) is substantially equivalent to LDL Cholesterol Plus (K012287) 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 LDL-Cholesterol.
This is achieved by a homogenous method that directly measures serum LDL-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 HDL, VLDL and chylomicrons leaving the LDL particles exposed.
1
510(k) SUMMARY CONT'D
page 2 of 2
The second reagent (R2) contains enzymes, which then react with the LDLcholesterol present in the sample.
Indications for use:
Direct LDL Chollesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of lowdensity lipoprotein cholesterol (LDL-C) in serum or plasma. LDL 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 LDL-Cholesterol Liquid Color , calibrated with Direct HDL/LDL -Cholesterol Calibrator (Stanbio) and LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche) using 62 patient samples. A correlation coefficient of 0.9969 and a regression equation of y = 1.025x - 4.0289 was obtained.
Also, precision, linearity, sensitivity and interference studies were performed on Stanbio Direct LDL-Cholesterol Liquid Color . Results of these tests were within acceptable range.
The result of LDL-cholesterol using Stanbio Direct LDL-Cholesterol Liquid Color is linear to 700mg/dl.
For the analytical sensitivity, a change of 0.001 absorbance units is equivalent to approximately 0.4mg/dl of LDL Cholesterol.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 2 2004
Ms. Adaobi Oguchi Quality Control Manager Stanbio Laboratory 1261 North Main Street Boerne, TX 78006
Re: K032936
Trade/Device Name: Stanbio Laboratory Direct LDL 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; MRR 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/clsmamain.html.
Sincerely yours.
Jean M. Cooper, US, 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
510(k) Number (if known): J
Stanbio Laboratory Direct LDL Cholesterol LiquiColor® and Stanbio Direct Device Name: HDL/LDL Cholestero] Calibrator
Indications for use:
Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma.
LDL 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) OR Over the Counter Use Prescription Use (Per 21 CFR801.109)
Carol Benson
Division Sign
510(K) K032936
(Optional Format 1-2-96)