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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Strong correlation (R-value approaching 1)	Correlation coefficient (R-value): 0.9987 (vs. predicate device)
	Bias (slope near 1, intercept near 0)	Regression equation: y = 1.01x - 0.4942 (vs. predicate device)
Precision	Within acceptable range	"Results of these tests were within acceptable range."
Linearity (Analytical Range)	Clearly defined upper limit	Linear to 200 mg/dl
Sensitivity	Clearly defined lower detection limit	A change of 0.001 absorbance units is equivalent to approximately 0.4 mg/dl of HDL Cholesterol.
Interference Studies	Within acceptable range	"Results of these tests were within acceptable range."

Note: The document does not explicitly state the numerical acceptance criteria for precision and interference. It only states that the results were "within acceptable range." For method comparison, the implied criterion is a strong correlation, which the reported 0.9987 satisfies. The regression equation also indicates minimal bias.

2. Sample Size and Data Provenance for the Test Set

Sample Size: 50 patient samples were used for the correlation (method comparison) study.
Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the phrasing "using 50 patient samples" suggests it was likely prospective for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The study relies on method comparison against a predicate device, not expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by comparison to a predicate device's measurements, not by human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic device for quantitative determination of a biomarker, not an imaging device requiring human reader interpretation. Therefore, the effect size of human reader improvement with or without AI assistance is not relevant or measured.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, linearity, sensitivity, interference) was evaluated independently. The method comparison study also assesses the device's performance against a reference method without human interpretation as part of the measurement process.

7. Type of Ground Truth Used

The ground truth for the method comparison study was established by the measurements obtained from a legally marketed predicate device: HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
For other analytical performance studies (precision, linearity, sensitivity, interference), the ground truth is typically derived from established laboratory protocols and reference materials but this is not explicitly detailed beyond stating the results were "within acceptable range."

8. Sample Size for the Training Set

This information is not applicable or provided. This device is a chemical reagent system, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" would relate to its chemical formulation and optimization during development, not data-driven learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or provided for the reasons stated in point 8.

Summary

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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® ; DirectHDL/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 StreetBoerne, 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.

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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:

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.

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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).

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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

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X232932 510(k) Number (if known): ____________________

Stanbio Laboratory Direct HDL Cholesterol LiquiColor® and Stanbio Direct Device Name: HDL/LDL Cholesterol Calibrator

Indications for use:

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)

Over the Counter Use

Carol Benson

ivision Slan-O

Office of In Vitro Diagn Device Evaluation and

510(k) K032932

Regulation Number and Section

§ 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.