(18 days)
No
The summary describes a calibrator product for a clinical chemistry system, with no mention of AI or ML in its function or description.
No.
The device is a calibrator used to calibrate a ferritin diagnostic method on a clinical chemistry system, not to provide therapeutic treatment to a patient.
No.
Explanation: The device is a calibrator for a clinical chemistry system, used to ensure the accuracy of a diagnostic test (ferritin measurement), but it does not directly diagnose a condition itself.
No
The device description clearly states it is a "liquid bovine albumin-based product" and contains "human liver ferritin," indicating it is a physical substance, not software.
Based on the provided information, the Ferritin Calibrator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's used to "calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system." This system is used for clinical chemistry testing, which involves analyzing biological samples (like blood or serum) outside the body to diagnose or monitor medical conditions. Calibration is a crucial step in ensuring the accuracy of these diagnostic tests.
- Device Description: The description mentions it's a "liquid bovine albumin-based product" containing "human liver ferritin." These are biological components used in the calibration process for a diagnostic test.
- Predicate Device: The mention of a predicate device (K963493; Dimension® Ferritin Calibrator) strongly suggests that this device is regulated as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory clearance of new IVD devices.
- Intended User/Care Setting: The intended user is associated with a "clinical chemistry system," which is a setting where IVD testing is performed.
While the document doesn't explicitly state "In Vitro Diagnostic," the context of its intended use, description, and predicate device clearly align with the definition and characteristics of an IVD device. It's a reagent used to ensure the accuracy of a diagnostic test performed on biological samples outside the body.
N/A
Intended Use / Indications for Use
The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
Product codes
JIT
Device Description
The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Dimension® Ferritin Calibrator, K963493
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KG83548
Dade Behring
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
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: | Cathy P. Craft
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | October 5, 1998 |
| Name of Product: | Ferritin Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Dimension® Ferritin Calibrator, K963493 |
Device Description: The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.
Intended use: The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
Comparison to Predicate Device:
| Item | Cleared Ferritin Calibrator | Modified Ferritin Calibrator |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | ferritin | ferritin |
| Matrix | bovine albumin base | bovine albumin base |
| Form | lyophilized | liquid |
| Volume | 2.0 mL per vial, reconstituted | 1.0 mL per vial |
| Levels | 5 levels | 5 levels |
| Reference | WHO standard, 2nd IS | WHO standard, 3rd IS |
1
Comments on Substantial
Equivalence: Both the cleared Ferritin Calibrator and the modified Ferritin Calibrator are intended to be used as calibrators for the Dimension® Ferritin (FERR) method.
Conclusion: The modified Ferritin Calibrator is substantially equivalent to the cleared Ferritin Calibrator based on the comparison discussed above.
Cathy P. Craft Regulatory Affairs and Compliance Manager Date: October 5, 1998
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 7 1998
Ms. Cathy P. Craft Regualtory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delware 19714-6101
K983548 Re : Trade Name: Ferritin Calibrator Requlatory Class: II Product Code: JIT Dated: October 5, 1998 Received: October 9, 1998
Dear Ms. Craft:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known) K983548
Device Name: Ferritin Calibrator
Indications for Use:
The Ferritin Calibrator is intended to be used to calibrate the Ferritin (FERR) Method on the Dimension® RxL clinical chemistry system.
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Cathy P. Craft Regulatory Affairs and Compliance Manager
October 5, 1998
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
| (Division Sign-Off) | |
|---|---|
| Division | Medical Laboratory Devices |
| 510(k) Number | KG8354 |
Image /page/4/Picture/10 description: The image shows the words "Prescription Use" with a check mark next to it. Below that, it says "(Per 21 CFR 801.109)". The text is in a simple, sans-serif font and is likely part of a form or document.
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Over-The-Counter Use