(146 days)
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No
The summary describes a chemical reagent-based test system for measuring bilirubin levels, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No
The device is intended to measure bilirubin levels for diagnostic purposes, not to treat a condition.
Yes
The intended use explicitly states that measurements of bilirubin levels are "used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders."
No
The device description explicitly states the device is comprised of two reagents, which are physical components, not software.
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 test systems are "devices intended to measure the levels of bilirubin (direct and total) in serum and plasma." It also mentions that these measurements are "used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders." This clearly indicates that the device is used to examine specimens derived from the human body (serum and plasma) to provide information for diagnostic purposes.
- Device Description: The description details the components of the test kits (reagents), which are used to perform the in vitro test.
- Performance Studies: The document describes performance studies like precision, correlation, sensitivity, and linearity, which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The mention of "Predicate Device(s)" with K numbers (K910593 and K910591) indicates that this device is being compared to previously cleared IVD devices, a common process for regulatory submission of new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JFM
Device Description
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.
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
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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
Linearity, precision studies (intra and inter), interference studies, and sensitivity.
Direct Bilirubin LiquiColor®:
Precision: Intra-assay Precision n = 20, Inter-assay Precision n = 20.
Correlation: Determination of bilirubin by the procedure described (y) and by 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: 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: Intra-assay Precision n = 20, Inter-assay Precision n = 20.
Correlation: Determination of bilirubin by the procedure described (y) and by 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: 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.
Key Metrics
Direct Bilirubin LiquiColor®:
Intra-assay Precision (n=20) Sample 1: Mean 0.36 mg/dL, SD 0.01 mg/dL, CV 3.12%. Sample 2: Mean 0.76 mg/dL, SD 0.01 mg/dL, CV 1.46%. Sample 3: Mean 2.07 mg/dL, SD 0.03 mg/dL, CV 1.30%.
Inter-assay Precision (n=20) Sample 1: Mean 0.35 mg/dL, SD 0.01 mg/dL, CV 3.34%. Sample 2: Mean 0.75 mg/dL, SD 0.01 mg/dL, CV 1.00%. Sample 3: Mean 2.13 mg/dL, SD 0.02 mg/dL, CV 0.71%.
Correlation: r = 0.995.
Sensitivity: 0.1 mg/dL per 0.001 absorbance units.
Comparison of Plasma vs. Serum: r = 0.9999.
Total Bilirubin LiquiColor®:
Intra-assay Precision (n=20) Sample 1: Mean 0.89 mg/dL, SD 0.03 mg/dL, CV 3.05%. Sample 2: Mean 1.02 mg/dL, SD 0.02 mg/dL, CV 2.32%. Sample 3: Mean 4.83 mg/dL, SD 0.05 mg/dL, CV 0.95%.
Inter-assay Precision (n=20) Sample 1: Mean 0.87 mg/dL, SD 0.02 mg/dL, CV 2.74%. Sample 2: Mean 1.15 mg/dL, SD 0.04 mg/dL, CV 3.49%. Sample 3: Mean 4.65 mg/dL, SD 0.13 mg/dL, CV 2.86%.
Correlation: r = 0.999.
Sensitivity: 0.07 mg/dL per 0.001 absorbance units.
Comparison of Plasma vs. Serum: r = 0.9995.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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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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:
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.
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
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