(66 days)
Not Found
No
The document describes a calibrator for a clinical chemistry system, which is a standard laboratory reagent. There is no mention of AI or ML in the intended use, device description, or any other section. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is a calibrator used to calibrate a method on a clinical chemistry system, not to treat a medical condition.
No
The device is a calibrator, used to calibrate a diagnostic method, not to directly diagnose a condition.
No
The device description clearly states it is a "liquid product" consisting of vials containing human serum, indicating it is a physical calibrator, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system." Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: The device is a "liquid product" containing "stripped human serum" and "L-triiodothyronine." These are components used in laboratory testing to calibrate instruments that measure substances in biological samples (like blood).
- Predicate Device: The mention of a "Predicate Device" with a K number (K953160) and name ("Opus Total T3 Calibrator") strongly indicates that this device is being compared to a previously cleared IVD device. This is a common regulatory pathway for IVDs.
The device is designed to be used in vitro (outside the body) to calibrate an instrument that performs diagnostic testing on biological samples. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.
Product codes (comma separated list FDA assigned to the subject device)
JIS
Device Description
The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.
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.
Opus Total T3 Calibrator (K953160)
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.
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Summary of Safety and Effectiveness Information
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: | Lorraine Piestrak
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | August 29, 2003 |
| Name of Product: | Dimension® Total Triiodothyronine (T3) Calibrator (RC414) |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Opus Total T3 Calibrator (K953160) |
Device Description: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.
Intended use: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.
Comparison to Predicate Device:
| | Dimension®
T3 Calibrator | Opus
Total T3 Calibrator |
|--------------|-------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | T3 | T3 |
| Matrix | stripped human serum base | stripped human serum base |
| Form | liquid | liquid |
| Volume | 2 mL per vial @ level 1
1 mL per vial @ levels 2-5 | 2 mL per vial @ level 1
1 mL per vial @ levels 2-6 |
| Levels | 5 levels
@ 0, 1, 2, 4, 6.5 ng/ml | 6 levels
@ 0, 0.5, 1, 2, 4, 6 ng/ml |
Comments on Substantial Equivalence: Both the proposed Dade Behring Dimension® Total Triiodothyronine (T3) Calibrator (RC414) and the existing Opus Total T3 calibrator are in vitro diagnostic products intended for calibrating T3 assays.
Conclusion: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is substantially equivalent to the Opus Total T3 Calibrators based on the comparison discussed above.
Lorraine Piestrak
Fraine Piestrak Regulatory Affairs and Compliance Manager August 29, 2003
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Larraine Piestrak Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community P.O. Box 6101 - Building 500 Newark, Delaware 19714
NOV - 7 2003
Re: K032697
Trade/Device Name: Dimension® Total Triiodothyronine Calibrator (RC414) Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS Dated: August 29, 2003 Received: September 2, 2003
Dear Ms. Piestrak:
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). 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.
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
iteven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Device Name: Dimension® Total Triiodothyronine Calibrator (RC414)
Indications for Use:
The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.
Lorraine Piestrak
Regulatory Affairs and Compliance Manager
August 29, 2003
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use
Carol Benson / Jean Cooper, DVM
Division Sign-Off
$10(k) K032697
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