(78 days)
The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.
The BILI calibrator is a two level calibrator. Level 1, purified system water, is provided on-board the Dimension Vista® System. Level 2 is a liquid, bovine serum albumin based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.
This 510(k) summary describes a calibrator device, not a diagnostic device that processes patient data. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable as they pertain to the evaluation of diagnostic performance on patient samples.
The document focuses on demonstrating substantial equivalence to a predicate calibrator.
Here's the information that can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the calibrator's performance against specific metrics (e.g., accuracy, precision). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing attributes. The "performance" reported primarily relates to the characteristics of the calibrator itself rather than measured performance in a study against acceptance criteria.
| Attribute | Predicate Device (TDBIL Calibrator) Reported Performance | Proposed Device (BILI Calibrator) Reported Performance |
|---|---|---|
| Intended Use | Calibration of DBIL and TBIL methods on Dimension Vista™ System | Calibration of DBIL and TBIL methods on Dimension Vista® System |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human Serum | Bovine Serum |
| Levels | One (CAL A) + on-board purified system water (Level 1) | One (CAL A) + on-board purified system water (Level 1) |
| Bilirubin Conc. Level 2 (Total, mg/dL) | 27.5 | 27.5 |
| Bilirubin Conc. Level 2 (Direct, mg/dL) | 19.25 | 17.5 |
| Form | Lyophilized | Liquid |
| Volume | 3 vials, 1 mL each (hydrated) | 3 vials, 2.5 mL each |
| Traceability | NIST SRM 916a | NIST SRM 916a |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a calibrator, not a diagnostic device evaluated on patient samples. The document focuses on the characteristics of the calibrator itself and its substantial equivalence to a predicate calibrator. There is no "test set" of patient data in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See explanation above. The ground truth for the calibrator's concentration is established by traceability to NIST Standard Reference Material 916a, not by expert consensus on biological samples.
4. Adjudication method for the test set
- Not Applicable. See explanation above.
5. 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 a calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a calibrator; there is no "algorithm" in the sense of a diagnostic interpretation model.
7. The type of ground truth used
- For the calibrator values: The calibrator's values are traceable to NIST Standard Reference Material (SRM) 916a. This serves as the ground truth for the bilirubin concentrations.
8. The sample size for the training set
- Not Applicable. This is a calibrator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
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510(k) Summary for Dimension Vista® System Bilirubin Calibrator (BILI ČAL - KC210)
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| 510 (k) Number: | K072717 | DEC 1 2 2007 |
|---|---|---|
| Analyte: | Bilirubin | |
| Type of Test: | Calibrator Material | |
| Applicant: | Dade Behring Inc .P.O. Box 6101Newark, DE 19714-6101Helen M. Lee Regulatory Affairs and Compliance ManagerOffice Phone: 302.631.8706Fax: 302.631.6299 | |
| Proprietary and Established Name: | Dimension Vista® System Bilirubin Calibrator (BILI CAL - KC210) | |
| Regulatory Information: | Regulation Section: 21 CFR § 862.1150 - CalibratorClassification: Class IIProduct Code: JIT - Calibrator, SecondaryPanel: Clinical Chemistry | |
| Intended Use: | The BILI CAL is an in vitro diagnostic product for the calibration ofDirect Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on theDimension Vista® System. | |
| Device Description: | The BILI calibrator is a two level calibrator. Level 1, purified systemwater, is provided on-board the Dimension Vista® System. Level 2 isa liquid, bovine serum albumin based material spiked withditaurobilirubin and traceable to NIST Standard Reference Material916a. |
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510(k) Summary for Dimension Vista® System Bilirubin Calibrator (BILI CAL - KC210)
Substantial Equivalence Information:
Predicate Device: Dimension Vista™ System TBIL Flex reagent cartridge and TDBIL Calibrator (K061719).
Comparison to the Predicate Device:
| Attribute | Dimension Vista™ SystemTDBIL Calibrator (Predicate) | Dimension Vista® SystemBILI Calibrator (Proposed) |
|---|---|---|
| Intended Use | 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. | The BILI CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System. |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human Serum | Bovine Serum |
| Levels | One (CAL A) | One (CAL A) |
| Bilirubin Concentration in (mg/dL) | Level 1- is on-board, purified system water | Level 1- is on-board, purified system water |
| Total (TBIL)Direct (DBIL) | Level 2 (27.5)Level 2 (19.25) | Level 2 (27.5)Level 2 (17.5) |
| Form | Lyophilized | Liquid |
| Volume | 3 vials, 1 mL each vial (hydrated volume) | 3 vials, 2.5 mL each |
| Traceability | National Institute of Standards and Technology (NIST), Standard Reference Material (SRM) 916a. | National Institute of Standards and Technology (NIST), Standard Reference Material (SRM) 916a |
Comments on Substantial Equivalence:
Both the proposed Dade Behring Dimension Vista® BILI Calibrator and the existing Dimension Vista® TDBIL Calibrator are in vitro diagnostic products for calibrating the DBIL and TBIL methods.
Conclusion:
The Dimension Vista® BILI Calibrator is substantially equivalent to the Dimension Vista™ TDBIL Calibrator based upon the comparison discussed above.
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Public Health Service
DEC 1 2 2007
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Dade Behring Inc. c/o Ms. Helen M. Lee. Regulatory Affairs & Compliance Manager P.O. Box 6101, Mail Box 514 Newark, DE 19714-6101
Re: K072717
Trade Name: Dimension Vista® System Bilirubin Calibrator (BILI CAL - KC210) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 05, 2007 Received: November 06, 2007
Dear Ms. Lee:
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and 809); 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 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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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Indications for Use Statement
510(k) Number (if known): K072717
Device Name:
Dimension Vista® System BILI Calibrator (KC210)
Indications for Use:
The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Sign-Off
Office of In Vitro Diagnostic Device untion and Safety ,
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.