(83 days)
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system.
The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.
The Dimension® EXL™ with LM clinical chemistry system is a floor model, fully automated, microprocessor-controlled, integrated instrument system which uses prepackaged Dade Behring Flex® reagent cartridges to measure a variety of analytes in human body fluids. The system can process samples in random access, batch or stat modes.
The Dimension® FT4L Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.
The LOCI® Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroxine. There are four calibrator levels with target values of 0.8, 1.6, 4.0 and 8.4 ng/dL.
The provided text describes a 510(k) premarket notification for the Dimension® EXL™ with LM clinical chemistry system, Dimension® FT4L Flex® reagent cartridge, and LOCI® Thyroid Calibrator. The primary study described is a method comparison study between the new Dimension® FT4L Flex® reagent cartridge and its predicate device, the Dimension® Vista FT4 Flex® reagent cartridge.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "slope must be between 0.95 and 1.05 and r > 0.98"). However, the study aims to demonstrate "excellent correlation" and substantial equivalence to the predicate device. The results indicate that this goal was met.
| Metric | Acceptance Criteria (Implied by "excellent correlation" and "substantial equivalence") | Reported Device Performance (Dimension® FT4L Flex® vs. Dimension® Vista FT4 Flex®) |
|---|---|---|
| Correlation Coefficient (r) | High correlation (e.g., > 0.98 for strong agreement) | 0.999 (Demonstrates excellent correlation) |
| Slope | Close to 1 (indicating proportional agreement) | 0.97 |
| 95% CI for Slope | Narrow interval around 1 | 0.96-0.97 |
| Y-intercept | Close to 0 (indicating no constant bias) | -0.03 |
| Sy,x (Standard Error of the Estimate) | Low value (indicating small scatter around the regression line) | 0.08 ng/mL |
2. Sample Size and Data Provenance
- Sample Size for Test Set: One hundred-and-eighty (180) serum samples.
- Data Provenance: Not explicitly stated whether the data is retrospective or prospective, nor the country of origin. It's common for such studies to use prospectively collected samples or a mix, but this information is absent.
3. Number of Experts and Qualifications for Ground Truth
The study described is a method comparison study between two in vitro diagnostic devices. It does not involve human interpretation or subjective assessment that would require experts to establish a "ground truth" in the traditional sense (like in image analysis or clinical diagnosis). Instead, the "ground truth" in this context is the measurement obtained from the predicate device.
4. Adjudication Method
Not applicable. This was a direct comparison of measurements between two automated analytical methods, not a study requiring adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of an in vitro diagnostic assay, comparing its measurements to a predicate device. It does not assess the diagnostic effectiveness with or without AI assistance for human readers.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily assesses the standalone performance of the Dimension® FT4L Flex® reagent cartridge on the Dimension® EXL™ with LM system by comparing its quantitative measurements to those of the predicate device. The "algorithm" here refers to the entire analytical process of the device, from reagent interaction to signal detection and calculation.
7. Type of Ground Truth Used
The ground truth used for the comparison was the measurements obtained from the predicate device, the Dimension® Vista FT4 Flex® reagent cartridge. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices.
8. Sample Size for Training Set
The document does not explicitly mention a "training set" or "training data" in the AI/machine learning sense. For in vitro diagnostic devices, method comparison studies typically use a test set to validate performance against a predicate. If method development and internal validation occurred, they would have used various samples, but these are not referred to as a "training set" in this context and their size is not provided.
9. How Ground Truth for Training Set Was Established
Not applicable, as a "training set" in the machine learning sense is not described. For the general development of such IVD assays, ground truth for initial development and calibration would typically be established using reference materials, certified calibrators, and samples characterized by a reference method or highly accurate established methods. However, these details are not provided in the summary.
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MAR 1 3 2008
510(k) Summary of Safety and Effectiveness Dimension® EXL™ with LM clinical chemistry system, Dimension® FT4L Flex® reagent cartridge and LOCI® Thyroid Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________
l. Manufacturer's Name, Address, Telephone, and Contact Person, Datc of Preparation
Manufacturer:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
February 18, 2008
2. Device Name / Classification
Dimension® EXLTM with LM clinical chemistry system / Class I Dimension® FT4L Flex® reagent cartridge / Class II LOCI® Thyroid Calibrator / Class II
3. Identification of the Predicate Device
Dimension® RxL Max® clinical chemistry system (the Dimension® RxL Max is a family member of the Dimension® XL clinical chemistry system, which was cleared under K944093} Dimension Vista™ FT4 Flex® reagent cartridge, K053531 Dimension Vista™ LOCI 1 Calibrator, K053531
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4. Device Description
The Dimension® EXL™ with LM clinical chemistry system is a floor model, fully automated, microprocessor-controlled, integrated instrument system which uses prepackaged Dade Behring Flex® reagent cartridges to measure a variety of analytes in human body fluids. The system can process samples in random access, batch or stat modes.
The Dimension® FT4L Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.
The LOCI® Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroxine. There are four calibrator levels with target values of 0.8, 1.6, 4.0 and 8.4 ng/dL.
5. Device Intended Use
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXL™ with LM system.
The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.
Medical device to which equivalence is claimed and comparison information 6.
The Dimension® EXL™ with LM system is substantially equivalent in intended use and technological characteristics to the Dimension® RxL Max® system. Both instruments are fully automated, microprocessor-controlled integrated instruments with similar detection technologies and modes of operation.
The Dimension® FT4L Flex® reagent cartridge is substantially equivalent in intended use and technological characteristics to the Dimension® Vista FT4 Flex® reagent cartridge. Both devices use LOCI technology and are intended for use in the quantitative measurement of Free Thyroxine in human serum and plasma. The devices have identical measuring ranges of 0.1 - 8.0 ng/dL.
The LOCI® Thyroid Calibrator is substantially equivalent in intended use and technological characteristics to the Dimension® LOCI 1 Calibrator. Both calibrators use a matrix comprised of stripped bovine albumin spiked with USP-grade Thyroxine.
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Comparison Information
Method comparison studies were conducted on the Dimension® FT4L Flex® vs. the Dimension® Vista FT4 Flex® reagent cartridge using one hundred-and-eighty (180) serum samples. The data was analyzed using least squares linear regression. The Dimension® FT4L Flex® demonstrated excellent correlation to the predicate device as evidenced by a correlation coefficient = 0.999. The resulting regressions statistics are shown below.
| Slope | 0.97 |
|---|---|
| 95% CI | 0.96-0.97 |
| y-int | -0.03 |
| r | 0.999 |
| Sy,x | 0.08 ng/mL |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. c/o Ms. Yuk-Ting Lewis, Regulatory Affairs and Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714-6101
MAR 13 2008
Re: K073604 Trade/Device Name: Dimension® FT4L Flex® reagént cartridge LOCI® Thyroid Calibrator Dimension® EXL™ with LOCI® Module (LM) Clinical Chemistry System Regulation Number: 21 CFR§ 862.1695 Regulation Name: Free thyroxine test system. Regulatory Class: Class II Product Code: CEC, JIT, JJE Dated: December 20, 2007 Received: December 21, 2007
Dear Ms. Lewis:
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 Eederal 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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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K073604
Device Name: Dimension® FT4L Flex® reagent cartridge LOCI® Thyroid Calibrator Dimension® EXL™ with LM clinical chemistry system
Indications For Use:
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system.
The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073604
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.