(67 days)
Not Found
No
The device description and performance studies focus on chemical reactions and analytical measurements, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic test used for quantitative measurement of total bilirubin, not for performing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the TBIL method is "an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma" and that "Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a reagent cartridge and calibrator, which are physical components used in an in vitro diagnostic test. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the TBIL Flex® reagent cartridge and the TDBIL Calibrator are "in vitro diagnostic test" and "in vitro diagnostic product" respectively. It also describes their use in the "quantitative measurement of total bilirubin in human serum and plasma" for the "diagnosis and treatment of liver, hemolytic hematological and metabolic disorders". This clearly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details the chemical reactions and measurement techniques used to analyze the sample, which is characteristic of an in vitro diagnostic test.
- Predicate Device: The mention of a predicate device with a K number (K861700) indicates that this device is being compared to a previously cleared IVD.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TBIL Flex® reagent cartridge:
The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.
TDBIL Calibrator:
The TDBIL Calibrator is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
CIG, JIT
Device Description
TBIL Flex® reagent cartridge
Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. Bilirubin (unconjugated) in the sample is solubilized by dilution in a mixture of caffeine/benzoate/acetate/EDTA. Upon addition of the diazotized sulfanilic acid, the solubilized bilirubin including conjugated bilirubins (mono and diglucoronides) and the delta form (biliprotein-bilirubin covalently bound to albumin) is converted to diazo-bilirubin, a red chromophore representing the total bilirubin which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique. A sample blank correction is used.
Solubilized bilirubin + Diazotized sulfanilic acid ---------------------------------------------------------------------------------------------------------------------------
Total bilirubin and Direct bilirubin calibrator.
The TDBIL calibrator is a two level calibrator. Level 1, purified water, is provided through the on-board Dimension Vista™ system. Level 2 is a lyophilized human serum based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.
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)
Comparison to the predicate device:
Testing results demonstrate that the Dimension Vista™ TBIL Flex® reagent cartridge and the associated TDBIL Calibrator are equivalent to the predicate devices. Method comparison results provided a slope of 0.94, intercept of 0.4 mg/dL and correlation of 0.999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 0.1 mg/dL
Within Lab Precision: 5%CV @ 0.9 mg/dL; 2.9%CV @ 19.3 mg/dL
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
§ 862.1110 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.
0
Image /page/0/Picture/0 description: The image contains a handwritten text string that appears to read "Ka 1719". The characters are written in a cursive style, with the 'K' and 'a' connected. The numbers '1719' are written in a simple, upright style and are spaced closely together. The text is dark against a light background, making it easily readable.
2006
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.
| Submitter's Name: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101
302-631-9798
302-631-6299 (fax) | AUG 25 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|--------|
| Date of Preparation: | June 16, 2006 | |
| Name of Products: | Dimension Vista™ TBIL Flex® reagent cartridge
Dimension Vista™ TDBIL Calibrator | |
| FDA Classification Name: | Bilirubin (total or direct) test system
Bilirubin Calibrator | |
| Predicate Device: | Dade Behring Dimension® TBIL Flex® reagent cartridge and
TBIL/DBIL Calibrator (K861700) | |
Device Description:
TBIL Flex® reagent cartridge
Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. Bilirubin (unconjugated) in the sample is solubilized by dilution in a mixture of caffeine/benzoate/acetate/EDTA. Upon addition of the diazotized sulfanilic acid, the solubilized bilirubin including conjugated bilirubins (mono and diglucoronides) and the delta form (biliprotein-bilirubin covalently bound to albumin) is converted to diazo-bilirubin, a red chromophore representing the total bilirubin which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique. A sample blank correction is used.
Solubilized bilirubin + Diazotized sulfanilic acid ---------------------------------------------------------------------------------------------------------------------------
Total bilirubin and Direct bilirubin calibrator.
The TDBIL calibrator is a two level calibrator. Level 1, purified water, is provided through the on-board Dimension Vista™ system. Level 2 is a lyophilized human serum based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.
Intended Use:
TBIL Flex® reagent cartridge:
The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.
1
TDBIL Calibrator:
The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.
Comparison to the predicate device:
The TBIL Flex® reagent cartridge and TDBIL Calibrator are substantially equivalent in intended use, principle and performance to the predicate Dade Behring TBIL assay and TBIL/DBIL Calibrator, K861700. The assays are in vitro assays with intended use for the measurement of total bilirubin in human serum and plasma. Both calibrators are for use of calibration of the total and direct bilirubin in vitro assays.
A summary of the features of the predicate and Dimension Vista™ TBIL Flex® reagent cartridge assays is provided in the following chart. Although the intended use statements have been modified for the test assay to align with CFR 862.1110, there are no different claims for the test assay.
| Attribute | Dimension® TBIL Assay (predicate) | Dimension Vista™ TBIL Assay |
|---|---|---|
| Intended Use | The TBIL method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of total bilirubin in serum and plasma. | The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease. |
| Sample type | Human serum and plasma | Human serum and plasma |
| Methodology | Photometric (diazo chemistry) | Photometric (diazo chemistry) |
| Detection | Bichromatic (540, 700 nm) | Bichromatic (540, 700 nm) |
| Sample volume | 28 uL | 5 uL |
| Hemoglobin Correction | Up to 500 mg/dL Hemoglobin | Up to 1000 mg/dL Hemoglobin |
| Analytical Sensitivity | Not provided | 0.1 mg/dL |
| Within Lab Precision | 2.4%CV at 0.9 mg/dL | |
| 9.6%CV @ 18.9 mg/dL | 5%CV @ 0.9 mg/dL | |
| 2.9%CV @ 19.3 mg/dL | ||
| Reference Interval | George M. Plummer Quality Assurance and Compliance Manager Date: June 16, 2006 |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing service to the people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 5 2006
George M. Plummer Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Business Community P.O. Box 6101, Mailstop 514 Newark, DE, 19714-6101
Re: K061719
Trade/Device Name: TBIL Flex® reagent cartridge TDBIL Calibrator Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, JIT Dated: June 16, 2006 Received: June 19, 2006
Dear Mr. Plummer,
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 (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 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications For Use Statement
510(k) Number (if known): { 06/719
Device Name:
TBIL Flex® reagent cartridge TDBIL Calibrator
Indications for Use:
TBIL Flex® reagent cartridge:
The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista 100 System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.
TDBIL Calibrator:
The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.
Prescription Use X (Per 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
ivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
061719