(67 days)
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 CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.
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.
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.
Here's a breakdown of the acceptance criteria and the study information for the Dade Behring Dimension Vista™ TBIL Flex® reagent cartridge and TDBIL Calibrator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Dimension Vista™ TBIL Assay) |
|---|---|---|
| TBIL Flex® reagent cartridge | ||
| Intended Use | Quantitative determination of total bilirubin in serum and plasma. | Quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Used in diagnosis and treatment of liver, hemolytic hematological and metabolic disorders (hepatitis, 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 | < 1 mg/dL | <1 mg/dL |
| TDBIL Calibrator | ||
| Intended Use | Calibration of DBIL and TBIL methods on Dimension® clinical chemistry system. | Calibration of Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System. |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human serum | Human serum |
| Levels | Three (L1 (0.8), L2 (9.4), L3 (21) for TBIL; L1 (0.6), L2 (6.9), L3 (14.5) for DBIL) | One (Level 2 (27.5) for TBIL; Level 2 (19.25) for DBIL). On-board purified system water is used for level 1. |
| Form | Lyophilized | Lyophilized |
| Volume | 6 vials, 2 vials each level, 1 mL each vial (hydrated volume) | 3 vials, 1mL each vial (hydrated volume). |
| Overall Comparison | Method comparison results provided a slope of 0.94, intercept of 0.4 mg/dL and correlation of 0.999 when compared to the predicate device. The conclusion states "substantially equivalent in principle and performance." This implies acceptance relative to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Method comparison results provided a slope of 0.94, intercept of 0.4 mg/dL and correlation of 0.999." However, the sample size (N) for this method comparison or the provenance of the data (e.g., country of origin, retrospective or prospective) for the test set is not explicitly mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The device is an in vitro diagnostic test for quantitative measurement, which typically relies on analytical methods rather than expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for this type of analytical device. Adjudication methods are typically used when subjective interpretations (e.g., image readings) are involved in establishing ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not provided in the document. An MRMC study is relevant for devices that assist human readers (e.g., imaging devices), which is not the case for this in vitro diagnostic assay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The performance data presented (Analytical Sensitivity, Within Lab Precision, Method Comparison) are inherently standalone performance of the device, as it is an automated in vitro diagnostic assay. It operates without human interpretation in the loop for the actual measurement.
7. The Type of Ground Truth Used
The ground truth for the comparison was established by the predicate device's measurements, along with traceability of the TDBIL calibrator to NIST Standard Reference Material 916a. This indicates a reliance on established analytical standards and a legally marketed predicate device as the reference for equivalence.
8. The Sample Size for the Training Set
The document pertains to a 510(k) submission for an in vitro diagnostic device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML does not apply here. The device's performance is based on its chemical methodology and analytical validation, not on being "trained" with data.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a training set is not applicable to this device.
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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. PlummerDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101302-631-9798302-631-6299 (fax) | AUG 25 |
|---|---|---|
| Date of Preparation: | June 16, 2006 | |
| Name of Products: | Dimension Vista™ TBIL Flex® reagent cartridgeDimension Vista™ TDBIL Calibrator | |
| FDA Classification Name: | Bilirubin (total or direct) test systemBilirubin Calibrator | |
| Predicate Device: | Dade Behring Dimension® TBIL Flex® reagent cartridge andTBIL/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.
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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/dL9.6%CV @ 18.9 mg/dL | 5%CV @ 0.9 mg/dL2.9%CV @ 19.3 mg/dL |
| Reference Interval | < 1 mg/dL | <1 mg/dL |
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| Attribute | Dimension® TBIL/DBILCalibrator (predicate) | Dimension Vista™ TDBILCalibrator |
|---|---|---|
| Intended Use | The Dimension® BilirubinCalibrator is an in vitrodiagnostic product to be usedto calibrate the Dimension®clinical chemistry system forthe Direct Bilirubin (DBIL)and Total Bilirubin (TBIL)methods. This product wasdesigned to meet the needs ofusers to assure accurate resultsover the assay range of thesemethods. | The TDBIL CAL is an invitro diagnostic product forcalibration of the DirectBilirubin (DBIL) and TotalBilirubin (TBIL) methods onthe Dimension Vista™System. |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human serum | Human serum |
| Levels | Three | One |
| Bilirubin concentration (mg/dL)Total (TBIL)Direct (DBIL) | L1 (0.8), L2 (9.4), L3 (21)L1 (0.6), L2 (6.9), L3 (14.5) | Level 2 (27.5)Level 2 (19.25)On-board purified systemwater is used for level 1. |
| Form | Lyophilized | Lyophilized |
| Volume | 6 vials, 2 vials each level, 1mL each vial (hydratedvolume) | 3 vials, 1mL each vial(hydrated volume). |
A summary of the features of the predicate and Dade Behring Dimension TDBIL calibrator is provided in the following chart.
Comments on Substantial Equivalence:
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.
Conclusion:
The Dimension Vista™ TBIL Flex® reagent cartridge and the associated TDBIL Calibrator are substantially equivalent in principle and performance to the predicate products.
George M. Plummer Quality Assurance and Compliance Manager Date: June 16, 2006
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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
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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
§ 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.