(83 days)
The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.
The Dimension® TACR Calibrator is a stabilized human whole blood hemolysate product containing tacrolimus. The kit consists of two vials of each calibrator level 1-5. The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus.
The provided text describes the 510(k) summary for the Dimension® TACR Calibrator. However, it does not contain the specific details required to fully address your request regarding acceptance criteria, study results, sample sizes, expert qualifications, or ground truth establishment.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain any explicit acceptance criteria or reported device performance data. It focuses on the device description, intended use, and substantial equivalence to a predicate device. For diagnostic/calibrator devices, acceptance criteria would typically involve metrics like accuracy, precision, linearity, stability, and possibly bias relative to a reference method, but these are not present in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective study) from primary performance studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not describe the establishment of ground truth by experts for a test set. As a calibrator, its "ground truth" would likely be the reference concentration of tacrolimus used in its manufacturing, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set:
Since no test set or expert evaluation is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess the AI's impact on human performance. This type of study is not applicable to a device like the Dimension® TACR Calibrator, which is an in vitro diagnostic calibrator and not an AI-powered diagnostic imaging tool. Therefore, no such study was performed or is relevant here, and no effect size for human improvement with AI is mentioned.
6. Standalone (Algorithm Only) Performance:
The Dimension® TACR Calibrator is a physical product (stabilized human whole blood hemolysate containing tacrolimus) used to calibrate an instrument. It is not an algorithm or software that would have "standalone performance" in the way an AI diagnostic tool would. Its performance is related to its ability to accurately provide known concentrations for calibration. The document does not present any standalone performance data in terms of accuracy, precision, etc., but rather focuses on its composition and intended use.
7. Type of Ground Truth Used:
The "ground truth" for a calibrator like this would be the known, manufactured concentrations of tacrolimus in each calibrator level. The document states: "The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus." This indicates the intended values used for calibration. It's not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This device is a calibrator, not a machine learning model that requires a "training set" of data in the conventional sense. The concept of a training set does not apply here.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set, this question is not applicable. The "ground truth" (target concentrations) for the calibrator itself would be established through a carefully controlled manufacturing process using highly accurate reference materials and methods.
Summary of Missing Information in the Provided Text:
The provided 510(k) summary is a high-level regulatory document intended to demonstrate substantial equivalence, not a detailed scientific study report. It specifically lacks:
- Quantitative acceptance criteria for the calibrator's performance.
- Results from any performance studies (e.g., accuracy, precision, stability).
- Details on test sets, sample sizes, or data provenance for performance evaluation.
- Information on expert involvement or ground truth establishment related to diagnostic accuracy, as it's a calibrator.
To get the detailed information you are seeking regarding performance metrics and study specifics for the Dimension® TACR Calibrator, you would typically need to consult the full submission to the FDA, product manuals, or other technical documentation that would be more extensive than this 510(k) summary.
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MAY 18 2006
510(k) Summary Dimension® TACR Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
060503
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
Feb. 20, 2006
2. Device Name / Classification
Dimension® TACR Calibrator / Class II
3. Identification of the Predicate Device
Abbott IMx® Tacrolimus Il Calibrators, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.)
4. Device Description
The Dimension® TACR Calibrator is a stabilized human whole blood hemolysate product containing tacrolimus. The kit consists of two vials of each calibrator level 1-5. The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus.
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5. Device Intended Use
The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.
6. Medical device to which equivalence is claimed and comparison information
The Dimension® TACR Calibrators are substantially equivalent in intended use and technological characteristics to the Abbott IMx® Tacrolimus II Calibrators. Both devices are calibrators intended for use as a reference in measuring tacrolimus with their respective assays. The Dimension® TACR Calibrators consist of 5 calibrator levels - 0, 3, 6, 12, 32.5 ng/mL tacrolimus - in whole whole blood hemolysate. The Abbott IMx® Tacrolimus II Calibrators consist of 6 calibrator levels - 0, 3, 6, 12, 20, and 30 ng/mL in whole blood hemolysate.
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Image /page/2/Picture/0 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like form intertwined around the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yuk-Ting Lewis Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101
MAY 18 2006
Re: K060503
Trade/Device Name: Dimension® TACR Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: April 20, 2006 Received: May 4, 2006
*Dear Ms. Lewis:
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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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
510(k) Number (if known): ¿ ○ 6 ○ S C
Dimension® TACR Calibrator Device Name:
Indications For Use:
The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
Children Children
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
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Office of In Viten Diagnostic Device Evaluation and Safety
510(k) K060503
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.