(45 days)
The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of transferrin (TRNF) by its polyclonal antibody.
The Acceptance Criteria for the device, TRNF Flex® Reagent Cartridge, are based on demonstrating substantial equivalence to its predicate device, the Beckman Array® TRF method. The primary criterion used for this determination is a strong statistical correlation between the results obtained from both methods when testing clinical patient samples.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Substantial Equivalence | Correlation Coefficient (r) between TRNF Flex® and Predicate Device | Expected to be high, indicating strong agreement (e.g., >0.95) | 0.984 |
| Slope of regression line (TRNF Flex® vs. Predicate Device) | Expected to be close to 1.0, indicating proportional agreement | 0.90 | |
| Intercept of regression line (TRNF Flex® vs. Predicate Device) | Expected to be close to 0, indicating minimal constant bias | 7.9 mg/dL | |
| Clinical Sample Type | Ability to measure Transferrin in Human Serum and Heparinized Plasma | Must be able to use both sample types for intended use | Serum and plasma (Predicate device only specified Serum) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: 95 clinical patient samples.
- Data Provenance: The data is retrospective, as it involves a "split sample comparison" of historical clinical patient samples. The country of origin is not explicitly stated, but given the submission is to the FDA in the USA, it's highly likely to be U.S.-based or a region with similar clinical practices.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The study relies on a comparative method (split sample comparison) rather than subjective expert interpretation for establishing ground truth. The "ground truth" for this device is effectively the measurements produced by the legally marketed predicate device, which is assumed to be accurate and reliable.
4. Adjudication Method for the Test Set
None. The ground truth is established by the measurements from the predicate device. There is no mention of independent expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not applicable to an in vitro diagnostic device for quantitative measurement like the TRNF Flex® Reagent Cartridge. MRMC studies are typically used for imaging or diagnostic aids where human interpretation is a key component.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, in essence. The entire evaluation of the TRNF Flex® Reagent Cartridge is a standalone performance assessment. The device itself (the reagent and the Dimension® clinical chemistry system) provides a quantitative measurement, and its performance is compared directly to another quantitative device (the predicate device). There is no "human-in-the-loop" interaction in the measurement process being tested.
7. Type of Ground Truth Used
The ground truth used is the measurements obtained from a legally marketed predicate device (Beckman Array® TRF method). This falls under a form of "established method comparison" or "reference method comparison."
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its size. The 95 clinical patient samples appear to be the primary dataset used for the performance evaluation and comparison to the predicate device. For quantitative assays like this, method development and calibration would typically involve a different process than the "training set" concept used in machine learning for image analysis, for instance.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" as commonly understood in AI/ML contexts is not mentioned, the method for establishing its ground truth is not applicable/not provided. The "ground truth" for the performance evaluation was established by running the same 95 clinical patient samples on the predicate device.
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4 2000 FEB
DADE BEHRI
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: | Richard M. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101 | |
|---|---|---|
| Date of Preparation: | December 20, 1999 | |
| Name of Product: | TRNF Flex® Reagent Cartridge | |
| FDA Classification Name: | Transferrin, Antigen, Antiserum, Control; 82DDG | |
| Predicate Device: | Beckman Array® Transferrin (TRF) method (K780913; K922273) |
Device Description: The TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of transferrin (TRNF) by its polyclonal antibody.
Intended Use: The TRNF Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure TRNF in human serum and heparinized plasma.
Comparison to Predicate Device:
| Dimension® TRNF Flex® | Beckman.TRF method | |
|---|---|---|
| Item | Reagent Cartridge | |
| Sample Type | Serum and plasma | Serum |
| Methodology | Immunoprecipitation | Immunoprecipitation |
| Antibody | Rabbit polyclonal | Goat polyclonal |
| Detection | Bichromatic endpoint | Nephelometry |
| (340 and 700 nm) | (405 nm) | |
| (turbidimetry) |
Comments on Substantial Equivalence: Split sample comparison between the TRNF Flex® reagent cartridge method and the Beckman Array® TRF method gave a correlation coefficient of 0.984, slope of 0.90, and an intercept of 7.9 mg/dL when tested with 95 clinical patient samples.
Conclusion: The TRNF Flex® reagent cartridge method is substantially equivalent in principle and performance to the Beckman Array® TRF method based on the split sample comparison discussed above.
R m Vaught
Richard M. Vaught
Regulatory Affairs and Compliance Manager Date: December 20, 1999
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FEB 4 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re: K994294 Trade Name: Dimension® TRNF Flex® Reagent Cartridge Regulatory Class: II Product Code: DDG Dated: December 20, 1999 Received: December 21, 1999
Dear Mr. Vaught:
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 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" (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 Butman
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® TRNF Flex® Reagent Cartridge
Indications for Use:
The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
R M. Van
Richard M. Vaught Regulatory Affairs and Compliance Manager
December 20, 1999
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maxim
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(Division Sign-Off) Division of Clinical Labora
ﺎ Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).