(74 days)
unknown, K970389
Not Found
No
The description details a chemiluminescent immunoassay technology (LOCI™) for measuring free thyroxine. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is a standard biochemical assay.
No
This device is an in-vitro diagnostic test for measuring Free thyroxine, used in the diagnosis and treatment of thyroid disease. It is a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in-vitro diagnostic test" and that "Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease."
No
The device description clearly outlines a chemical immunoassay process involving reagents, beads, and light detection, indicating a hardware component is essential for its function.
Yes, both devices described are explicitly stated to be In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use / Indications for Use: Both sections clearly state that the devices are "in-vitro diagnostic test" or "in-vitro diagnostic product."
- Purpose: The intended use describes the measurement of analytes (Free Thyroxine, Free Triiodothyronine, Thyroid Stimulating Hormone) in human specimens (serum and plasma) for the purpose of diagnosis and treatment of thyroid disease. This is a core function of IVD devices.
- Device Description: The description details the technology used to measure these analytes in a laboratory setting, which is consistent with IVD devices.
- Performance Studies: The inclusion of performance studies comparing the device to a predicate device (ADVIA Centaur FrT4 assay) is a standard requirement for demonstrating the performance of an IVD device.
- Predicate Device: The mention of a predicate device (ADVIA Centaur FrT4 assay and K970389 Thyroid Calibrator) further confirms that these devices are being compared to existing IVD devices.
Therefore, based on the provided text, both the Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) and the Dimension Vista™ LOCI I Calibrator are IVD devices.
N/A
Intended Use / Indications for Use
The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is an in-vitro diagnostic test for the quantitative measurement of Free thyroxine in human serum and plasma.
The Dimension Vista™ LOCI I Calibrator is an in-vitro diagnostic product intended for the calibration of Thyroid Stimulating Hormone (TSH), Free Triodothyronine (FT3), and Free Thyroxine (FT4).
The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is a device intended to measure Free (not protein bound) thyroxine (thyroid hormone) in serum and 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 disease.
The Dimension Vista™ LOCI I Calibrator is a device intended for medical purposes for use in the determination of values in the test of Free Thyroxine (FT4), Free Triiodothyronine (FT3), and Thyroid Stimulating Hormone (TSH) in human specimens.
Product codes (comma separated list FDA assigned to the subject device)
CEC, JIT
Device Description
The FT4 method is a homogenous, sequential, chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. The LOCI™ reagents include two latex bead reagents and a biotinylated anti-T4 mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with triiodothyronine (T3), a naturally occurring, weaker binding analog of T4. and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated antibody which allows T4 from the sample to saturate a fraction of the biotinylated antibody that is directly related to the free T4 concentration. In a second step, T3 chemibeads are added and form bead/ biotinylated antibody immunocomplexes with the non-saturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. When illuminated by light at 680 nm, sensibeads convert dissolved oxygen in the reaction solution into the singlet oxygen form ('O2). In the bead pairs, the singlet oxygen diffuses ("channels") into chemibeads, triggering a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is an inverse function of the concentration of free T4 in the sample.
The Dimension Vista™ LOCI I Calibrator is a three level, liguid, multi-analyte product. This product's matrix is bovine serum albumin and it contains buffer, stabilizer and preservatives. Level A is a zero level, while levels B and C contain human thyroxine, triodothyronine and thyroid stimulating hormone. Values are assigned to the calibrator from a masterpool that is traceable through a patient correlation study to an existing comparative method for FT3 and FT4. The TSH value is referenced to the WHO standard, 2nd IRP 80/588, and confirmed with the 3rd IS 81/565.
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)
Split sample comparison between the Dimension Vista™ FT4 Flex™® reagent cartridge and ADVIA Centaur FrT4 assay gave the following correlation statistics, when tested with clinical patient samples:
Method Comparison Data Dimension VistaTM FT4 vs Predicate Method:
Sample Type: Serum
Slope: 1.03
Intercept: 0.02
Correlation Coefficient (r): 0.983
n: 108
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r) = 0.983
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.
unknown, K970389
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
§ 862.1695 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.
0
2006 MAR 3
K 05353/
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: | Lorraine H Piestrak |
|---|---|
| Dade Behring Inc. | |
| P.O. Box 6101 | |
| Newark, DE 19714-6101 |
Date of Preparation: December 16, 2005
Name of Product:
Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) Dimension Vista™ LOCI 1 Calibrator
FDA Classification Name:
| Free Thyroxine test system | (Class II) |
|---|---|
| Calibrator, Secondary | (Class II) |
Predicate Device:
The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:
| New
Product | Predicate
Device | 510(k)
number | Device
Class | Regulation | Product
Code |
|---------------------------------------------------------------------|--------------------------|------------------|-----------------|------------|-----------------|
| Dimension Vista™ Free
Thyroxine (FT4) Flex® reagent
cartridge | ADVIA Centaur FrT4 assay | unknown | II | 862.1695 | CEC |
| Dimension Vista™
LOCI 1 Calibrator | Thyroid Calibrator | K970389 | II | 862.1150 | JIT |
Device Description:
The FT4 method is a homogenous, sequential, chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. The LOCI™
1
reagents include two latex bead reagents and a biotinylated anti-T4 mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with triiodothyronine (T3), a naturally occurring, weaker binding analog of T4. and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated antibody which allows T4 from the sample to saturate a fraction of the biotinylated antibody that is directly related to the free T4 concentration. In a second step, T3 chemibeads are added and form bead/ biotinylated antibody immunocomplexes with the non-saturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. When illuminated by light at 680 nm, sensibeads convert dissolved oxygen in the reaction solution into the singlet oxygen form ('O2). In the bead pairs, the singlet oxygen diffuses ("channels") into chemibeads, triggering a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is an inverse function of the concentration of free T4 in the sample.
The Dimension Vista™ LOCI I Calibrator is a three level, liguid, multi-analyte product. This product's matrix is bovine serum albumin and it contains buffer, stabilizer and preservatives. Level A is a zero level, while levels B and C contain human thyroxine, triodothyronine and thyroid stimulating hormone. Values are assigned to the calibrator from a masterpool that is traceable through a patient correlation study to an existing comparative method for FT3 and FT4. The TSH value is referenced to the WHO standard, 2nd IRP 80/588, and confirmed with the 3rd IS 81/565.
Intended Use:
The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is an in-vitro diagnostic test for the quantitative measurement of Free thyroxine in human serum and plasma.
The Dimension Vista™ LOCI I Calibrator is an in-vitro diagnostic product intended for the calibration of Thyroid Stimulating Hormone (TSH), Free Triodothyronine (FT3), and Free Thyroxine (FT4).
Comparison to Predicate Device:
Both the Dimension Vista™ Free Thyroxine Flex® reagent cartridge and the predicate Advia Centaur FrT4 assay employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the important similarities and differences of these methods is provided in the following table:
2
| Feature | Dimension Vista™ Free
Thyroxine (FT4) Flex® reagent
cartridge | ADVIA Centaur FrT4 assay |
|--------------|---------------------------------------------------------------------|----------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Sample Type | Serum and Plasma | serum |
| Assay Range | 0.1 - 8.0 ng/dL | 0.1 - 12.0 ng/dL |
| Technology | chemiluminescent | chemiluminescent |
| Sample Size | 10 µL | 25 µL |
| Antibody | Anti - T4 mouse monoclonal | Anti -T4 rabbit polyclonal |
| Feature | Dimension Vista™ LOCI I Calibrator | Dimension® Thyroid Calibrator |
|---|---|---|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Analytes | FT4, TSH, FT3 | FT4, TSH |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Form | liquid | liquid |
| Volume | A 2.5 mL per vial | |
| B 1.5 mL per vial | ||
| C 2.0 mL per vial | 2 mL per vial | |
| Levels | 3 levels | 5 levels |
Comments on Substantial Equivalence:
Split sample comparison between the Dimension Vista™ FT4 Flex™® reagent cartridge and ADVIA Centaur FrT4 assay gave the following correlation statistics, when tested with clinical patient samples:
3
| Dimension
Vista™ | Predicate | Sample
Type | Slope | Intercept | Correlation
Coefficient (r) | n |
|---------------------|-----------------------|----------------|-------|-----------|--------------------------------|-----|
| FT4 | ADVIA Centaur
FrT4 | Serum | 1.03 | 0.02 | 0.983 | 108 |
Method Comparison Data sion VistaTM FT4 vs Predicate Method
Conclusion:
The Dimension Vista™ FT4 Flex® reagent cartridge with the associated LOCI I calibrator is substantially equivalent in principle and performance to the ADVIA Centaur FrT4 assay based on the split sample comparison discussed above.
Louanie H Restrole
Lorraine H Piestrak Regulatory Affairs & Compliance Manager December 16, 2005
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is arranged on a single line. The font is simple and easy to read. The text is likely part of a document or sign.
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
2006 MAR 3
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manager Dade Behring Inc. PO Box 6101, M/S 514 Newark DE 19714- 6101
Re: K053531
Trade/Device Name: Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) Dimension Vista™ LOCI 1 Calibrator Regulation Number: 21 CFR$862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC, JIT Dated: December 16, 2005 Received: December 19, 2005
Dear Ms. Piestrak:
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 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).
5
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 vours,
Alberto Gutz
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
6
Indications for Use
510(k) Number (if known): K053531
Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) Device Name:
Indications For Use:
The Dimension Vista™ Free Thyroxine Flex® reagent cartridge (FT4) is a device intended to measure Free (not protein bound) thyroxine (thyroid hormone) in serum and 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 disease.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use --------(21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ivision Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K053531
7
Indications for Use
510(k) Number (if known): K053553
Device Name:
Dimension Vista™ LOCI 1 Calibrator
Indications For Use:
The Dimension Vista™ LOCI I Calibrator is a device intended for medical purposes for use in a the Dithenston + Iba - Dints of reference that are used in the determination of values in the test are creating of Free Thyroxine (FT4), Free Triiodothyronine (FT3), and Thyroid Stimulating Hormone (TSH) in human specimens.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use --------(21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
g Page 1 of
C.H
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K053531