(83 days)
P970007
Not Found
No
The summary describes a reagent cartridge for a clinical chemistry system and performance studies comparing it to predicate methods. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic test for measuring tacrolimus levels, which aids in managing tacrolimus therapy, rather than directly providing therapy itself.
Yes
The "Intended Use / Indications for Use" states that it is an "in vitro diagnostic test" and the "Device Description" section explicitly calls it an "in vitro diagnostic device".
No
The device description explicitly states it is a "reagent cartridge" which is a physical component containing prepackaged reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure tacrolimus in human whole blood..."
The "Device Description" section also states: "The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents..."
N/A
Intended Use / Indications for Use
The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Product codes (comma separated list FDA assigned to the subject device)
MLM
Device Description
The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dade Behring Dimension® clinical chemistry system.
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
Prescription Use
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)
Method comparison studies were conducted at two external sites comparing the Dimension® TACR Flex® reagent cartridge against two predicates:
- . liquid chromatography / tandem mass spectrometry (LC/MS/MS) and
- the Abbott IMx® Tacrolimus II Assay.
Samples from 2 transplant patient groups (liver and kidney) were included in the studies. The data from both sites were pooled and analyzed by Passing Bablok linear regression.
Comparative Method - LC/MS/MS:
All samples: Slope 1.13, Intercept -0.27, r 0.88, n 184
Kidney: Slope 1.16, Intercept -0.60, r 0.88, n 103
Liver: Slope 1.06, Intercept 0.49, r 0.88, n 81
Comparative Method - Abbott IMx® Tacrolimus II Assay:
All samples: Slope 0.92, Intercept 0.10, r 0.85, n 175
Kidney: Slope 0.90, Intercept -0.06, r 0.87, n 97
Liver: Slope 0.93, Intercept 0.45, r 0.82, n 78
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
P970007
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
§ 862.1678 Tacrolimus test system.
(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.
0
MAY 1 8 2006
510(k) Summary Dimension® TACR Flex® reagent cartridge
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:
The assigned 510(k) number is: صحب 60 حي
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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:
May 2, 2006
2. Device Name / Classification
Dimension® TACR Flex® reagent cartridge / Class II
3. Identification of the Predicate Device
Abbott IMx® Tacrolimus II Assay, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.)
4. Device Description
The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dade Behring Dimension® clinical chemistry system.
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ડ. Device Intended Use
The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
6. Medical device to which equivalence is claimed and comparison information
The Dimension® TACR Flex® reagent cartridge is substantially equivalent in intended use and technological characteristics to the Abbott IMx® Tacrolimus II Assay. Both devices are immunoassays intended for use in the quantitative measurement of tacrolimus in human whole blood. The Dimension® TACR Flex® reagent cartridge has an assay range of 1.2-30 ng/mL. The Abbott IMx® Tacrolimus II Assay has an assay range of 1.5-30 ng/mL
Comparison Information
Method comparison studies were conducted at two external sites comparing the Dimension® TACR Flex® reagent cartridge against two predicates:
- . liquid chromatography / tandem mass spectrometry (LC/MS/MS) and
- the Abbott IMx® Tacrolimus II Assay.
Samples from 2 transplant patient groups (liver and kidney) were included in the studies. The data from both sites were pooled and analyzed by Passing Bablok linear regression.
Comparative Method
| LC/MS/MS | Slope | Intercept | r | n |
|---|---|---|---|---|
| All samples | 1.13 | -0.27 | 0.88 | 184 |
| Kidney | 1.16 | -0.60 | 0.88 | 103 |
| Liver | 1.06 | 0.49 | 0.88 | 81 |
| Abbott IMx® Tacrolimus II Assay | ||||
| All samples | 0.92 | 0.10 | 0.85 | 175 |
| Kidney | 0.90 | -0.06 | 0.87 | 97 |
| Liver | 0.93 | 0.45 | 0.82 | 78 |
・・・・・・・・
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 18 2006
Ms. Yuk-Ting Lewis Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714
K060502 Trade/Device Name: Dimension® TACR Flex® reagent cartridge Regulation Number: 21 CFR§862.1678 Regulation Name: Tacrolimus test system Regulatory Class: Class II Product Code: MLM Dated: April 20, 2006 Received: April 21, 2006
Dear Ms. Lewis:
Re:
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): くつんてここ
Dimension® TACR Flex® reagent cartridge Device Name:
Indications For Use:
. . . . . . .
The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
C.A. Cox
Division Sigh-Off
210(K)
Office of In Vitro Diaznostic Device Evaluation and Safet
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