(24 days)
P970007
Not Found
No
The summary describes calibrators for a laboratory assay, which are reference materials, not a device that processes data or makes decisions using AI/ML. There is no mention of AI, ML, or related concepts.
No
The device is a calibrator used as a reference in measuring tacrolimus levels, not for treating any condition or disease.
No
Explanation: The device is described as "calibrators" used as a reference in measuring tacrolimus. Calibrators are used to establish a known relationship between the measured signal and the concentration of the analyte, essentially for "calibration" of an assay, not for directly diagnosing a condition. It is a component used in a diagnostic process, but not a diagnostic device itself.
No
The device description explicitly states the calibrators "contain tacrolimus in preserved whole blood hemolysate" and are provided in "vials," indicating a physical, non-software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "measuring tacrolimus in human whole blood." This involves testing a sample taken from the human body (in vitro).
- Device Description: The description confirms it contains "tacrolimus in preserved whole blood hemolysate," which is a biological sample.
- Predicate Device: The mention of a predicate device (Abbott IMx® Tacrolimus II Calibrators) which is also an IVD, further supports this classification.
Calibrators are essential components of many IVD assays, used to establish a standard curve for accurate measurement of the analyte (in this case, tacrolimus) in patient samples.
N/A
Intended Use / Indications for Use
The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay. The calibrators contain tacrolimus in preserved whole blood hemolysate. The calibrator kit consists of one vial of each calibrator level with target concentrations of 0, 2.5, 5, 10, 20, and 30 ng/mL of tacrolimus.
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)
Not Found
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.
Abbott IMx® Tacrolimus II Calibrators, 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
§ 862.1150 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.
0
MAR 9 2006
Dade Behring Inc. 510(k) Premarket Notification -- Emit® 2000 Tacrolimus Calibrators
510(k) Summary Emit® 2000 Tacrolimus Calibrators
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:
K06037/
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
Feb. 7, 2006
2. Device Name / Classification
Emit® 2000 Tacrolimus Calibrators / Class II
3. Identification of the Predicate Device
Abbott IMx® Tacrolimus II Calibrators, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.)
4. Device Description
The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay. The calibrators contain tacrolimus in preserved whole blood hemolysate. The calibrator kit consists of one vial of each calibrator level with target concentrations of 0, 2.5, 5, 10, 20, and 30 ng/mL of tacrolimus.
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Dade Behring Inc. 510(k) Premarket Notification - Emit® 2000 Tacrolimus Calibrators
5. Device Intended Use
The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.
6. Medical device to which equivalence is claimed and comparison information
The Emit® 2000 Tacrolimus 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 Emit® 2000 Tacrolimus Calibrators consist of 6 calibrator levels - 0, 2,5, 5, 10, 20 and 30 ng/mL - in 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is composed of three thick, curved lines that suggest feathers or wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
2006 MAR 9
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yuk-Ting Lewis Regulatory Affairs & Compliance Manager Dade Behring Inc. Glasgow Business Community P.O. Box 6101, Building 500, M/S 514 Newark, DE 19714-6101
Re: K060371
Trade/Device Name: Emit® 2000 Tacrolimus Calibrators Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: February 7, 2006 Received: February 13, 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 fisting (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 Guts
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
4
Dade Behring Inc.
510(k) Premarket Notification -- Emit® 2000 Tacrolimus Calibrators
Indications for Use
K060371 510(k) Number (if known):
Device Name: Emit® 2000 Tacrolimus Calibrators
Indications For Use:
The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.
Prescription Use × (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)
Carol C Benson
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060371