(62 days)
Not Found
No
The description details a standard immunoassay technology (LOCI™) and calibration process, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
The device is described as an in vitro diagnostic device used for the quantitative measurement of ferritin, which aids in the diagnosis of diseases. It does not directly treat or prevent a disease, which is the function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The FERR method is an in vitro diagnostic device..." and "Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines physical components (reagent cartridges, calibrators, beads, antibodies, dyes) and a chemical reaction process, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states: "The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma..." It also mentions the calibrator as an "in vitro diagnostic device".
- Device Description: The description details a laboratory assay that analyzes biological samples (serum and plasma) outside of the body to measure a specific analyte (ferritin). This is the core function of an in vitro diagnostic device.
- Performance Studies: The document describes a split sample comparison study using "clinical patient samples," which is typical for evaluating the performance of an IVD.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FERR method is an in vitro diagnostic test for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin and EDTA) on the Dimension Vista™ system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of the Ferritin (FERR) method on the Dimension Vista™ system.
Product codes (comma separated list FDA assigned to the subject device)
DBF, JIT
Device Description
The Dimension Vista™ FERR Flex® reagent cartridge assay is a homogenous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ reagents include two synthetic bead reagents and a biotinylated anti-ferritin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ferritin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form a particle/ferritin/biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 mm and is a direct function of the ferritin concentration in the sample.
The Dimension Vista™ LOCI 4 Calibrator is a five level, liquid calibrator. It is packaged as a kit of 10 vials, two vials each of five levels. The product matrix is 6% bovine serum albumin with buffer, stabilizer and preservatives. Level A is zero. Levels B through E contain Ferritin at the following target concentrations :
Level | Ferritin concentration |
---|---|
A | 0 ng/mL |
B | 26 ng/mL |
C | 210 ng/mL |
D | 1050 ng/mL |
E | 2000 ng/mL |
Values are assigned to new lots from a masterpool that is referenced to the WHO standard for FERR, 3 rd IS 94/572
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™ Ferritin Flex® reagent cartridge assay and the Dimension® Ferritin Flex® reagent cartridge assay gave the following correlation statistics, when tested with clinical patient samples:
Method Comparison Data Dimension Vista™ FERR vs. Predicate Method | |||||
---|---|---|---|---|---|
Dimension Vista™ | Predicate | Slope | Intercept | Correlation Coefficient (r) | n |
FERR | Dimension ® Ferritin | 1.01 | 1.48 ng/mL | 0.996 | 158 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r): 0.996
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
APR 3 0 2007
510(k)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: | February 26, 2007 |
| Name of Product: | Dimension Vista™ Ferritin Flex® reagent cartridge (FERR)
Dimension Vista™ LOCI 4 Calibrator |
FDA Classification Name: Ferritin immunological test system (Class II) Calibrator (Class II)
Predicate Device:
The following table describes the predicate device classification, regulation and product code associated with this pre-market notification:
| New
Product | Predicate
Device | 510(k)
number | Device
Class | Regulation | Product
Code |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|-----------------|------------|-----------------|
| Ferritin (FERR) Flex® reagent
cartridge for the Dimension
Vista™ system (K6440) | Ferritin (FERR) Flex®
reagent cartridge for the
Dimension® clinical
chemistry system (RF440) | K963498 | II | 866.5340 | DBF |
| Dimension Vista™ LOCI 4
Calibrator | Dimension FERR
Calibrator | K983548 | II | 862.1150 | JIT |
Device Description:
The Dimension Vista™ FERR Flex® reagent cartridge assay is a homogenous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ reagents include two synthetic bead reagents and a biotinylated anti-ferritin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ferritin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form a particle/ferritin/biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 mm and is a direct function of the ferritin concentration in the sample.
The Dimension Vista™ LOCI 4 Calibrator is a five level, liquid calibrator. It is packaged as a kit of 10 vials, two vials each of five levels. The product matrix is 6% bovine serum albumin with buffer, stabilizer and preservatives. Level A is zero. Levels B through E contain Ferritin at the following target concentrations :
1
| Level | Ferritin
concentration |
|-------|---------------------------|
| A | 0 ng/mL |
| B | 26 ng/mL |
| C | 210 ng/mL |
| D | 1050 ng/mL |
| E | 2000 ng/mL |
Values are assigned to new lots from a masterpool that is referenced to the WHO standard for FERR, 3 rd IS 94/572
Intended Use:
The FERR method is an in-vitro diagnostic test for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin and EDTA) on the Dimension Vista™ system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of the Ferritin (FERR) method on the Dimension Vista™ system.
Comparison to Predicate Device:
Both the Dimension Vista™ Flex® reagent cartridge (FERR) assay (catalogue number K6440) and the predicate Dimension® Ferritin Flex® reagent cartridge assay (catalogue number RF440) 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:
| Feature | Dimension Vista™ Ferritin
Flex® reagent cartridge
(K6440) | Dimension Ferritin Flex®
reagent cartridge
(RF440) |
|-----------------|-----------------------------------------------------------------|----------------------------------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Sample Type | Serum and Plasma | Serum and Plasma |
| Assay Range | 0- 2000 ng/mL | 0- 1000 ng/mL |
| Technology | Sandwich format monoclonal
antibody immunoassay | Sandwich format monoclonal
antibody immunoassay |
| Detection | Chemiluminescent reaction
measurement at 680 & 612 nm | Colorimetric rate measurement
at 577 & 700 nm |
| Sample Size | 2 µL | 40 µL |
| Antibody source | Monoclonal mouse | Monoclonal mouse |
2
Both the Dimension Vista™ LOCI 4 Calibrator and the predicate Dimension ® Ferritin Calibrator have the same intended use. A comparison of the important similarities and differences is provided in the following table:
| Feature | Dimension Vista™ LOCI 4
Calibrator | Dimension® Ferritin Calibrator |
|---------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Calibrate Ferritin on the
Dimension Vista™ system | Calibrate Ferritin on the
Dimension® clinical chemistry system |
| Analytes | Ferritin | Ferritin |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Traceable to: | WHO Standard for ferritin 3rd IS
94/572 | WHO Standard for ferritin 3rd IS
94/572 |
| Form | Liquid stored @ -10 to -20°C | Liquid stored @ 4 to 8°C |
| Volume | A 2.5 mL per vial
B 1.5 mL per vial
C 1.0 mL per vial
D 1.0 mL per vial
E 2.0 mL per vial | 1 ml per vial |
| Levels | 5 levels | 5 levels |
Comments on Substantial Equivalence:
Split sample comparison between the Dimension Vista™ Ferritin Flex® reagent cartridge assay and the Dimension® Ferritin Flex® reagent cartridge assay gave the following correlation statistics, when tested with clinical patient samples:
| Method Comparison Data
Dimension Vista™ FERR vs. Predicate Method | |||||
---|---|---|---|---|---|
Dimension | |||||
Vista™ | Predicate | Slope | Intercept | Correlation | |
Coefficient (r) | n | ||||
FERR | Dimension ® | ||||
Ferritin | 1.01 | 1.48 ng/mL | 0.996 | 158 |
Conclusion:
The Dimension Vista™ Ferritin Flex® reagent cartridge assay with the associated LOCI 4 Calibrator is substantially equivalent in principle and performance to the Dimension® Ferritin Flex® reagent cartridge assay based on the split sample comparison discussed above.
Lorraine H Piestrak Regulatory Affairs & Compliance Manager March 23, 2007
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
APR 3 0 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring Inc. c/o Ms. Lorraine H. Piestrak Regulatory Affairs and Compliance Manager P.O. Box 6101 Newark, DE 19714-6101
Re: K070552
Trade/Device Name: Dimension Vista™ Ferritin Flex® reagent cartridge Dimension Vista™ LOCI 4 Calibrator Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: DBF, JIT Dated: March 26, 2007 Received: March 27, 2007
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
4
Page 2 -
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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Beakerf
Robert L. Becker, Jr., M.D., Ph.D. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Ko 70552
Device Name: Dimension Vista™ Ferritin Flex® reagent cartridge (FERR)
Indications For Use:
The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
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)
Mari M Clar
Page 1 of
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko 70572
6
Indications for Use
KO 70552 510(k) Number (if known):
Device Name: Dimension Vista™ LOCI 4 Calibrator
Indications For Use:
The Dimension Vista™ LOCI 4 Calibrator is an in vitro diagnostic device intended to be used to calibrate the ferritin (FERR) assay on the Dimension Vista™ system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
Page 1 .of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ia mclam
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K070552