The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Device Description

The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® devices, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Direct Bilirubin)	Reported Device Performance (Total Bilirubin)
Precision (Intra-assay)	CV ≤ 3.12% (n=20)	CV ≤ 3.05% (n=20)
Precision (Inter-assay)	CV ≤ 3.34% (n=20)	CV ≤ 3.49% (n=20)
Correlation (vs. predicate)	r = 0.995 (y = 0.9394x - 0.06 mg/dL)	r = 0.999 (y = 1.0108x - 0.0145 mg/dL)
Sensitivity	0.1 mg/dL per 0.001 absorbance units	0.07 mg/dL per 0.001 absorbance units
Linearity	0.1 to 10 mg/dL	0.07 to 30 mg/dL
Comparison (Plasma vs. Serum)	r = 0.9999 (y = 1.0118x - 0.0078)	r = 0.9995 (y = 1.02x - 0.006)

Note: The document does not explicitly state numerical acceptance thresholds for each criterion but presents the results of the performance studies. It is implied that these reported performance metrics were considered acceptable for demonstrating substantial equivalence. For instance, the high correlation coefficients (r) suggest strong agreement with the predicate devices, which is a common acceptance criterion for equivalence in such tests.

Study Details

Sample size used for the test set and the data provenance:
- Direct Bilirubin Test Set:
  - Correlation: 85 samples.
  - Comparison (Plasma vs. Serum): 22 samples.
  - Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
- Total Bilirubin Test Set:
  - Correlation: 247 samples.
  - Comparison (Plasma vs. Serum): 19 samples.
  - Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that these are in vitro diagnostic devices for measuring analytes in human samples, the samples would typically be human serum or plasma.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are quantitative assays for chemical analytes, not image-based or clinical diagnostic tests requiring expert interpretation to establish ground truth in the traditional sense. The "ground truth" for the correlation and comparison studies is established by the results from a "commercially available test" (Roche Direct Bilirubin/Total Bilirubin tests).
Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is involved in determining the "ground truth" for these types of quantitative assays.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance data (precision, sensitivity, linearity) represents standalone performance, as it is a fully automated/instrument-based chemical assay. The "correlation" and "comparison" studies are essentially comparisons of the new device's standalone performance against another commercially available standalone device.
The type of ground truth used:
- For Correlation studies, the ground truth was established by the measurements obtained from the predicate devices: Roche Direct Bilirubin (K910593) and Roche Total Bilirubin (K910591).
- For Precision, Sensitivity, and Linearity, the ground truth is effectively the expected chemical value of the calibrators and samples used in the study, and the assessment is of the device's ability to consistently and accurately measure those values.
The sample size for the training set: Not applicable. This is a chemical assay, not an machine learning/AI model that requires training data.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY K050266

Submitter's Name and Address: Stanbio Laboratory 1261 North Main Street

Phone: (830) 249-0772 Fax: (830) 249-0851

Prepared By: Kirk Johnson May 2, 2005

Boerne, Texas 78006

Product Name

Trade Name:	Direct Bilirubin LiquiColor®; Total Bilirubin LiquiColor®
Common Name:	Direct Bilirubin Test; Total Bilirubin Test
Classification Name:	Enzymatic Method, Bilirubin
Classification:	II
Product Code:	JFM

Substantial Equivalence of Device

This test is substantially equivalent to:

Direct Bilirubin; Roche, 510(k) K910593 Product Name: Total Bilirubin: Roche, 510(k) K910591

Description of Device

Description of Dorroo The Direct Dim to the test kit, a calibrator is used that has values determined by a similar method.

The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Tour Diffaction Erican Is used that has values determined by a similar method.

Intended Use of Device

Inchued Ose of Device intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the micalod williabare the the or pound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and

Comparison of Devices

Comparison of Dolly absorbance change as a means for quantitative determination of direct and total Dom mounder employ accorning on plasma. The Stanbio method employs DCA (2,4-Dichloraniline), whereas, the Roche is a diazo-colorimetry method. The change in absorbance correlates with concentration of direct and total bilirubin.

Performance Data

I criormance Dual linearity, precision studies (intra and inter), interference studies, and sensitivity.

Direct Bilirubin LiquiColor®

Precision: (performed according to NCCLS EP-5A)

Intra-assay Precision n = 20
Sample Number	Mean	SD	CV
	mg/dL	mg/dL	%
1	0.36	0.01	3.12
2	0.76	0.01	1.46
3	2.07	0.03	1.30

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510(k) SUMMARY cont'd

Inter-assay Precision n = 20
Sample Number	Mean	SD	CV
1	mg/dL	mg/dL	%
1	0.35	0.01	3.34
2	0.75	0.01	1.00
3	2.13	0.02	0.71

Correlation: Determination of bilirubin by the procedure described (y) and by a another commercially available test (x) using 85 samples gave the following results: y = 0.9394x - 0.06 mg/dL; r = 0.995.

Sensitivity: The procedure showed a sensitivity of 0.1 mg/dL per 0.001 absorbance units.

Linearity: (Performed according to NCCLS EP6-P) Linear from 0.1 to 10 mg/dL.

Comparison of Plasma vs. Serum: Determination of Direct Bilirubin by the procedure described by y (serum) and by x (plasma) using 22 samples gave the following results: y = 1.0118x - 0.0078; r = 0.9999.

Total Bilirubin LiquiColor®

Precision: (performed according to NCCLS EP-5A)

Intra-assay Precision n = 20
Sample Number	Mean	SD	CV
	mg/dL	mg/dL	%
1	0.89	0.03	3.05
2	1.02	0.02	2.32
3	4.83	0.05	0.95
Inter-assay Precision n = 20
Sample Number	Mean	SD	CV
	mg/dL	mg/dL	%
1	0.87	0.02	2.74
2	1.15	0.04	3.49
3	4.65	0.13	2.86

Correlation: Determination of bilirubin by the procedure described (y) and by a another commercially available test (x) using 247 samples gave the following results: y = 1.0108x - 0.0145 mg/dL; r = 0.999.

Sensitivity: The procedure showed a sensitivity of 0.07 mg/dL per 0.001 absorbance units.

Linearity: (Performed according to NCCLS EP6-P) Linear from 0.07 to 30 mg/dL.

Comparison of Plasma vs. Serum: Determination of Direct Bilirubin by the procedure described by y (serum) and by x (plasma) using 19 samples gave the following results: y = 1.02x - 0.006; r = 0.9995.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol of three abstract, curved shapes. The text is arranged around the perimeter of the circle, and the symbol is positioned in the center.

Public Health Service

JUN 3 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Kirk Johnson QA/Regulatory Affairs Manager Stanbio Laboratory 1261 North Main St. Boerne, TX 78006

Re: K050266

K050200 Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: JFM Dated: May 2, 2005 Received: May 4, 2005

Dear Mr. Johnson:

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 I va may , aross 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 promated 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) 276-0484. 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 Pour may 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/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting 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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Indications for Use

510(k) Number (if known): K050266

Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert Cace

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K050266/51

: - - - -ﺴﺘ

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Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.