(36 days)
Not Found
No
The device description and performance studies focus on chemical composition, stability, and traceability to a standard reference material. There is no mention of AI or ML in the intended use, device description, or performance evaluation.
No
The device is described as an "in vitro diagnostic product" intended to calibrate an IRON method for a clinical chemistry system, not for direct therapeutic use on a patient.
No
This device is a calibrator, used to calibrate a diagnostic device (the IRON method for the Dimension® clinical chemistry system), not to directly diagnose a patient.
No
The device description clearly states it is an "aqueous solution of iron wire dissolved in a dilute solution of HCl" and comes in "6 ampules". This indicates a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the IRON Calibrator is an "in vitro diagnostic product."
- Function: Calibrators are essential components in many in vitro diagnostic tests. They are used to ensure the accuracy and reliability of the test results by setting the reference points for the measurement.
- Context: The device is intended to be used with a "clinical chemistry system" (Dimension®), which is a type of instrument used for performing in vitro diagnostic tests on biological samples.
Therefore, based on the provided information, the IRON Calibrator clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- l . Intended use(s): The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
-
- Indication(s) for use: The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
- Indications for Use: The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
JIS
Device Description
The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability: Target shelf life for the Dimension® IRON Calibrator is 12 months. Studies require 13 months of real time testing on three lots of product. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with product stored at -20℃ to ensure that analytical system drift is dissociated with calibrator drift.
Traceability: The assigned values of the IRON calibrator are standardized to NIST SRM 937 (NIST SRM: National Institute of Standards and Technology- Standard Reference Material). Six working Iron Standard Solutions of NIST SRM 937 (0, 25, 50, 75, 500, 1075 µg/dL) are prepared and used to assign each new lot of calibrator.
Value Assignment: The new calibrator levels are made by adding acid dissolved NIST 837 into base matrix. The new calibrator lots are assigned verses the six working standard solutions prepared from NIST SRM 937(Reference Lot). The new calibrator lot must have acceptable recovery verses the Reference Lot and a Control Calibrator Lot (Control Calibrator Lot = Any Approved Calibrator Lot).
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.
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
2006 MAR 9
510(k) Summary for the Dimension® Iron Calibrator (IRON Cal - DC 85)
长060266 A. 510(k) Number:
- B. Analyte: Iron Calibrator
- C. Type of Test: Calibrator Material
D. Applicant:
Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager (302) 631-9454
Date of Preparation: January 30, 2006
E. Proprietary and Established Names: Dimension® Iron Calibrator (IRON Calibrator- DC 85)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 -- CALIBRATOR
-
- Classification: Class II
-
- Product Code: JIS CALIBRATORS, PRIMARY
-
- Panel: CLINICAL CHEMISTRY
G. Intended Use:
-
l . Intended use(s):
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system. -
- Indication(s) for use:
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
- Indication(s) for use:
This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
-
- Special condition for use statement(s): none
-
- Special instrument Requirements: none
1
H. Device Description:
The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three levels.
. Substantial Equivalence Information:
-
- Predicate Device: Dimension® IRN/TIBC Calibrator (DC21)
2. Predicate K Number(s): K944093
3. Comparison with Predicate:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | To calibrate the iron method for the | |
| Dimension® clinical chemistry | ||
| system. | same | |
| Traceability | NIST SRM 937 (NIST SRM: National | |
| Institute of Standards and | ||
| Technology- Standard Reference | ||
| Material) | same | |
| Matrix | Aqueous solution of iron wire | |
| dissolved in a dilute solution of HCl | same | |
| Number of | ||
| Levels | 3 | same |
| Differences | ||
| Item | Device | Predicate |
| Target | ||
| Concentrations | 0, 50, 1075 ug/dL | 50, 500 1000ug/dL |
J. Standard/Guidance Document Referenced:
- Guidance;
Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999
Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004
- Standards: Continuous Quality Improvement Essential Management Approaches GP22-A Stability testing of In-Vitro Diagnostic Devices CEN 13640
2
Medical devices -Application of risk management to medical devices ISO 14971:2000 Medical devices -- Symbols to be used with medical device labeling ISO 15223 and information to be supplied
K. Test Principle:
The Dimension® Iron Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® IRON (Cat # DF85) method for the Dimension® clinical chemistry system.
L. Performance Characteristics:
- Stability
Target shelf life for the Dimension® IRON Calibrator is 12 months. Studies require 13 months of real time testing on three lots of product. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with product stored at -20℃ to ensure that analytical system drift is dissociated with calibrator drift.
2. Traceability:
The assigned values of the IRON calibrator are standardized to NIST SRM 937 (NIST SRM: National Institute of Standards and Technology- Standard Reference Material). Six working Iron Standard Solutions of NIST SRM 937 (0, 25, 50, 75, 500, 1075 µg/dL) are prepared and used to assign each new lot of calibrator.
3. Value Assignment
The new calibrator levels are made by adding acid dissolved NIST 837 into base matrix. The new calibrator lots are assigned verses the six working standard solutions prepared from NIST SRM 937(Reference Lot). The new calibrator lot must have acceptable recovery verses the Reference Lot and a Control Calibrator Lot (Control Calibrator Lot = Any Approved Calibrator Lot).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
2006 MAR 9
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community P.O. Box 6101, Building 500, M/S 514 Newark, DE 19714-6101
Re: K060266
Trade/Device Name: Dimension® IRON Calibrator (IRON Cal- DC85) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: January 30, 2006 Received: February 1, 2006
Dear Ms. Tasker:
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. Iisting 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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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 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
5
Indications For Use Statement
510(k) Number (if known):
Device Name:
Dimension® IRON Calibrator (IRON Cal- DC85)
Indications for Use:
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
Prescription Use 11 (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(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
Office of In Vitro Diagnostic Device Evaluation and Safety
313(x) K070266