(45 days)
The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.
The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each of three levels.
This document is a 510(k) summary for the Dimension® IBCT Calibrator, a device used to calibrate total iron binding capacity (IBCT) methods on the Dimension® clinical chemistry system. It is a regulatory submission, not a study report detailing specific performance metrics or clinical efficacy. Therefore, much of the requested information regarding acceptance criteria, study design, and performance statistics is not present in the provided text.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document is a 510(k) submission asserting substantial equivalence to a predicate device, not a performance study report with specific acceptance criteria and detailed device performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to the device as a "liquid protein based product" for calibration, implying its performance would be assessed in a laboratory setting for accuracy, precision, etc., but the details of such assessments are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The concept of "ground truth" as typically applied in AI/medical imaging studies (e.g., expert consensus on image interpretation) is not relevant to a calibrator device for clinical chemistry. The ground truth for a calibrator would be its accurate concentration and stability, which are established through analytical methods, not typically by expert interpretation in the way "ground truth" is used in the prompt. The primary standard for the calibrator is mentioned as "NIST Iron Standard SRM 937".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically used in studies involving human interpretation (e.g., radiologists reading images) to resolve discrepancies, which is not applicable to a calibrator device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. An MRMC study is relevant to imaging diagnostics or AI-assisted interpretation, where human readers are involved. This document describes a calibrator for a clinical chemistry system, which does not involve human readers interpreting "cases" in the same way.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a calibrator, not an algorithm. Its performance is inherent to its chemical composition and stability, and its effect on instrument accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the calibrator itself is established by its manufacturing process and verified against a primary standard. The document states:
- Primary standard: NIST Iron Standard SRM 937
This refers to a certified reference material used to ensure the accuracy of the calibrator's stated values. This is an analytical standard, not an "expert consensus" or "pathology" in the typical sense.
8. The sample size for the training set
This information is not provided in the document. The concept of a "training set" is not applicable to a calibrator device. Calibrators are manufactured products, not AI algorithms that require training data.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" for a calibrator device.
Summary regarding the provided document:
The provided document is a 510(k) premarket notification for a medical device (a calibrator). Its primary purpose is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present detailed performance data against specific acceptance criteria. Therefore, most of the questions, which are geared towards performance studies for diagnostic algorithms or imaging devices, are not addressed within this type of regulatory submission. The "study" referenced in the prompt's context is effectively the substantial equivalence comparison documented by the submitter, which focuses on device characteristics and intended use rather than specific clinical performance metrics.
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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: | Robin O. Norris |
|---|---|
| Dade Behring Inc. | |
| P.O. Box 6101 | |
| Newark, DE 19714-6101 | |
| Date of Preparation: | December 2, 1999 |
| Name of Product: | Dimension® IBCT Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Dimension® IRN/TIBC Calibrator, K863840 |
Device Description: The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each of three levels.
Intended use: The Dimension® IBCT Calibrator is intended to be used to calibrate the Total Iron Binding Capacity (IBCT) method on the Dimension® clinical chemistry system.
Comparison to Predicate Devices
| Item | Dimension® IRN/TIBC Calibrator | Dimension® IBCT Calibrator |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | iron | human transferrin |
| Matrix | aqueous solution | protein based solution |
| Form | liquid | liquid |
| Volume | 1.0 mL per ampule | 1.0 mL per vial |
| Levels | 3 levels | 3 levels |
| Reference | Primary standard --NIST Iron Standard SRM 937 | Primary standard --NIST Iron Standard SRM 937 |
Comments on Substantial Equivalence: Both the Dimension® IRN/TIBC Calibrator and the Dimension® IBCT Calibrator are intended to be used as calibrators for total iron binding capacity methods.
Conclusion: The Dimension® IBCT Calibrator is substantially equivalent to the Dimension® IRN/TIBC Calibrator based on the comparison discussed abd
Robin O. Norris
bin O. Norris Manager, Quality Assurance and Compliance December 2, 1999
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 2000
Ms. Robin O. Norris Manager, Quality Assurance and Compliance Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark. Delaware 19714-6101
Re: K994114
Trade Name: Dimension® IBCT Calibrator Regulatory Class: II Product Code: JIS Dated: December 2, 1999 Received: December 6, 1999
Dear Ms. Norris:
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 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). 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 Regulations, 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 OS 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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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" (21CFR 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 Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Device Name: Dimension® IBCT Calibrator
Indications for Use:
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The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.
Dan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
ivision of Clinical 510(k) Number
Robbi Onons
Robin O. Norris Manager, Quality Assurance and Compliance
December 2, 1999
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-the-counter Use
§ 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.