(195 days)
No
The device description details a chemiluminescent immunoassay technology (LOCI™) for quantitative measurement of analytes. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section of the summary. The technology described is a standard laboratory assay method.
No.
The device is an in vitro diagnostic test used for quantitative measurement of substances in human serum and plasma to aid in diagnosis and treatment, not to directly treat a condition.
Yes
The document explicitly states that the B12 Flex and FOL Flex reagent cartridges are "in vitro diagnostic tests" and that their measurements are "used in the diagnosis and treatment" of specific conditions. Additionally, the LOCI 4 Calibrator is described as an "in vitro diagnostic product".
No
The device description clearly details physical reagent cartridges and calibrators, which are hardware components used in an in vitro diagnostic system.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated in Intended Use: The "Intended Use / Indications for Use" section for both the B12 Flex® and FOL Flex® reagent cartridges, as well as the LOCI 4 Calibrator, explicitly states that they are "in vitro diagnostic test" or "in vitro diagnostic product."
- Measurement of Analytes in Human Samples: The devices are designed to measure Vitamin B12 and folate in human serum and plasma, which are biological samples taken from the human body.
- Used for Diagnosis and Treatment: The measurements obtained are used in the "diagnosis and treatment" of specific medical conditions (gastrointestinal malabsorption and megaloblastic anemia). This is a key characteristic of IVD devices.
- Laboratory-Based Testing: The description of the device and the performance studies indicate that these tests are performed on a laboratory system (Dimension Vista® system).
Therefore, all components described (the B12 Flex® reagent cartridge, the FOL Flex® reagent cartridge, and the LOCI 4 Calibrator) are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The B12 Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
The FOL Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of megaloblastic anemia.
The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of Ferritin (FERR), Vitamin B12 (B12), and Folate (FOL) methods on the Dimension Vista® system.
Product codes
CDD, CGN, JIX
Device Description
B12
The Dimension Vista® Vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCTM technology. LOCT™ reagents include two synthetic bead reagents and biotinylated intrinsic factor (IF). The first bead reagent (Chemibeads) is coated with a B12 derivative and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The patient sample is pretreated with NaOH to release the serum B12 from its carrier proteins. Potassium cyanide (KCN) is added to convert all the forms of B12 into a single, cyanocobalamin form, and dicyanocobinamide is added to keep the B12 from rebinding with the carrier proteins. After the sample pretreatment, the biotinylated IF and Chemibead reagents are added sequentially to the reaction vessel. Vitamin B12 from the sample competes with the B12-Chemibead for a limited amount of biotinylated IF. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from the Sensibeads which diffuses to the Chemibeads triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the concentration of vitamin B12 in the sample.
FOL
The Dimension Vista® Folate method is a homogenous, competitive chemiluminescent immunoassay based on LOCT™ technology. LOCT™ reagents include two synthetic bead reagents and labeled folate binding protein (FBP). The first bead reagent (Chemibeads) is coated with a folic acid derivative and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. Before the immunological portion of the reaction is initiated, the patient sample is pretreated with NaOH and DTT to release serum folate from endogenous folate binding protein and to maintain 5-methyl tetrahydrofolate in its reduced form. After the sample pretreatment, Chemibeads and labeled folate binding reagent are added sequentially to the reaction vessel. Folate from the patient sample competes with the folate-Chemibead for a limited amount of labeled FBP. Sensibeads are then added and bind to the biotinylated portion of the labeled FBP to form bead pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from the Sensibeads which diffuses to the Chemibeads triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the concentration of folate in the sample.
Calibrator
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, Vitamin B12, and Folate at the following target concentrations :
| Level | Ferritin
ng/mL | B12
pg/mL | Folate
ng/mL |
|-------|-------------------|--------------|-----------------|
| A | 0 | 0 | 0.0 |
| B | 26 | 200 | 2.5 |
| C | 210 | 500 | 5.0 |
| D | 1050 | 1000 | 10.0 |
| E | 2000 | 2100 | 21.0 |
Values are assigned to new lots from a masterpool that is referenced to the WHO standard for FERR, 3 14 IS 94/572 and United States Pharmacopoeia materials for B12 and Folate
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
Prescription Use
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
Split sample comparison between the Dimension Vista® B12 and FOL Flex® reagent cartridge assays and ADVIA Centaur® system VB12 and FOL assay gave the following correlation statistics, when tested with clinical patient samples:
| Dimension Vista® B12 and FOL vs. Predicate Method | |||||
|---|---|---|---|---|---|
| Dimension | |||||
| Vista® | Predicate | Slope | Intercept | Correlation | |
| Coefficient (r) | n | ||||
| B12 | VB12 for the | ||||
| ADVIA | |||||
| Centaur® | |||||
| System | 0.93 | -14.4 pg/mL | 0.98 | 124 | |
| FOL | FOL for the | ||||
| ADVIA | |||||
| Centaur® | |||||
| system | 1.02 | -0.07 ng/mL | 0.96 | 110 |
Key Metrics
B12:
Slope: 0.93
Intercept: -14.4 pg/mL
Correlation Coefficient (r): 0.98
n: 124
FOL:
Slope: 1.02
Intercept: -0.07 ng/mL
Correlation Coefficient (r): 0.96
n: 110
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is 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: | April 30, 2007 | |
| Name of Product: | 1. Dimension Vista® Vitamin B12 Flex® reagent cartridge (B12)
2. Dimension Vista® Folate Flex® reagent cartridge (FOL)
3. Dimension Vista® LOCI 4 Calibrator | |
FDA Classification Name:
- Radioassay, Vitamin B12 2. Acid, Folic, Radioimmunoassay 3. Calibrator
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 |
|----------------------------------------------------------------|---------------------------------------------|------------------|-----------------|------------|-----------------|
| B12 Flex® reagent cartridge for
the Dimension Vista® system | VB12 for the ADVIA
Centaur® System | K041133 | II | 862.1810 | CDD |
| FOL Flex® reagent cartridge for
the Dimension Vista® system | FOL for the ADVIA
Centaur® system | K010050 | II | 862.1295 | CGN |
| LOCI 4 Calibrator for the
Dimension Vista® system | FERR Calibrator for the
Dimension system | K983548 | II | 862.1150 | JIX |
Device Description:
B12
The Dimension Vista® Vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCTM technology. LOCT™ reagents include two synthetic bead reagents and biotinylated intrinsic factor (IF). The first bead reagent (Chemibeads) is coated with a B12 derivative and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The patient sample is pretreated with NaOH to release the serum B12 from its carrier proteins. Potassium cyanide (KCN) is added to convert all the forms of B12 into a single, cyanocobalamin form, and dicyanocobinamide is added to keep the B12 from rebinding with the carrier proteins. After the sample pretreatment, the biotinylated IF and Chemibead reagents are added sequentially to the reaction vessel. Vitamin B12 from the sample competes with the B12-Chemibead for a limited amount of biotinylated IF. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from the Sensibeads which diffuses to the
1
Chemibeads triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the concentration of vitamin B12 in the sample. FOL
The Dimension Vista® Folate method is a homogenous, competitive chemiluminescent immunoassay based on LOCT™ technology. LOCT™ reagents include two synthetic bead reagents and labeled folate binding protein (FBP). The first bead reagent (Chemibeads) is coated with a folic acid derivative and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. Before the immunological portion of the reaction is initiated, the patient sample is pretreated with NaOH and DTT to release serum folate from endogenous folate binding protein and to maintain 5-methyl tetrahydrofolate in its reduced form. After the sample pretreatment, Chemibeads and labeled folate binding reagent are added sequentially to the reaction vessel. Folate from the patient sample competes with the folate-Chemibead for a limited amount of labeled FBP. Sensibeads are then added and bind to the biotinylated portion of the labeled FBP to form bead pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from the Sensibeads which diffuses to the Chemibeads triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the concentration of folate in the sample. Calibrator
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, Vitamin B12, and Folate at the following target concentrations :
| Level | Ferritin
ng/mL | B12
pg/mL | Folate
ng/mL |
|-------|-------------------|--------------|-----------------|
| A | 0 | 0 | 0.0 |
| B | 26 | 200 | 2.5 |
| C | 210 | 500 | 5.0 |
| D | 1050 | 1000 | 10.0 |
| E | 2000 | 2100 | 21.0 |
Values are assigned to new lots from a masterpool that is referenced to the WHO standard for FERR, 3 14 IS 94/572 and United States Pharmacopoeia materials for B12 and Folate
Intended Use:
B12
The B12 method is an in-vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension Vista® system.
FOL
The FOL method is an in-vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension Vista® system.
Calibrator
The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of the Ferritin (FERR), Vitamin B12 (B12), and Folate (FOL) methods on the Dimension Vista® system.
2
Comparison to Predicate Device:
Both the Dimension Vitamin B12 Flex® reagent cartridge (B12) assay and the predicate VB12 assay on the ADVIA Centaur® System 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® B12 Flex®
reagent cartridge | VB12 on the ADVIA
Centaur® System |
|-----------------|----------------------------------------------------------|-------------------------------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Sample Type | Serum and Plasma | Serum and Plasma |
| Assay Range | 50 - 2000 pg/mL | 45 - 2000 pg/mL |
| Technology | Competitive format homogeneous
immunoassay | Competitive format heterogeneous
immunoassay |
| Detection | Chemiluminescent reaction
measurement at 680 & 612 nm | Chemiluminescent reaction
Wavelength not disclosed |
| Sample Size | 15 µL | 100 µL |
| Binding Protein | Purified porcine Intrinsic Factor | Purified porcine Intrinsic Factor |
Both the Dimension Vista® Folate Flex® reagent cartridge (FOL) assay and the predicate Folate(FOL) assay on the ADVIA Centaur® System 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® FOL Flex®
reagent cartridge | FOL on the ADVIA
Centaur® System |
|-----------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Sample Type | Serum and Plasma | Serum and Red Blood Cells |
| Assay Range | 0.5 - 20 ng/mL | 0.35 - 24 ng/mL |
| Technology | Competitive format immunoassay | Competitive format immunoassay |
| Detection | Chemiluminescent reaction
measurement at 680 & 612 nm | Chemiluminescent reaction
Wavelength not disclosed |
| Sample Size | 10 µL | 150 µL |
| Binding protein | Folate Binding Protein (FBP)
complexed with biotinylated mouse
monoclonal anti-FBP antibody | Biotinylated Folate Binding Protein |
3
Both the Dimension Vista® LOCI 4 Calibrator and the predicate Dimension® Ferritin Calibrator have similar 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, Vitamin B12 and
Folate on the
Dimension Vista® system | Calibrate Ferritin on the
Dimension® clinical chemistry system |
| Analytes | Ferritin, Vitamin B12, Folate | Ferritin |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Traceable to: | WHO Standard for ferritin
3rd IS 94/572 and
USP material for B12, and Folate | WHO Standard for ferritin 3rd IS
94/572 |
| Form | Liquid stored @ -10 to -20°C | Liquid stored @ 2 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 |
Note: The Dimension Vista® LOCI 4 Calibrator with Ferritin only is currently under review by FDA in K070552.
Comments on Substantial Equivalence:
Split sample comparison between the Dimension Vista® B12 and FOL Flex® reagent cartridge assays and ADVIA Centaur® system VB12 and FOL assay gave the following correlation statistics, when tested with clinical patient samples:
| Dimension Vista® B12 and FOL vs. Predicate Method | |||||
|---|---|---|---|---|---|
| Dimension | |||||
| Vista® | Predicate | Slope | Intercept | Correlation | |
| Coefficient (r) | n | ||||
| B12 | VB12 for the | ||||
| ADVIA | |||||
| Centaur® | |||||
| System | 0.93 | -14.4 pg/mL | 0.98 | 124 | |
| FOL | FOL for the | ||||
| ADVIA | |||||
| Centaur® | |||||
| system | 1.02 | -0.07 ng/mL | 0.96 | 110 |
Method Comparison Data
4
Conclusion:
The Dimension Vista® Vitamin B12 and Folate Flex® reagent cartridge assays with the associated LOCI 4 Calibrator are substantially equivalent in principle and performance to the ADVIA Centaur VB12 and FOL assays based on the split sample comparison discussed above.
Lorraine Pestiak
Lorraine H Piestrak Regulatory Affairs & Compliance Manager April 30, 2007
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2007
Dade Behring, Inc. c/o Ms Lorraine H Piestrak P.O. Box 6101 M/S 514 Newark, DE 19714
Re: K071224
Trade Name: Dimension Vista Vitamin B12 Flex reagent cartridge (B12), Dimension Vista Folate Flex reagent cartridge (FOL) and Dimension Vista LOCI 4 Calibrator Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CDD, CGN and JIX
Dated: October 15, 2007 Received: October 22, 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 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).
6
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) 276-0490. 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.
Yean 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
7
Indications for. Use
510(k) Number (if known):
Device Name: Dimension Vista® Vitamin B12 Flex® reagent cartridge (B12)
Indications For Use:
The B12 Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
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)
Carol C. Benson
Division Sign-
Office of In Vitao Diagnost Evaluation and Sa
10(k) K071224
Page 1 of
8
Indications for Use
510(k) Number (if known):
Device Name: Dimension Vista® Folate Flex® reagent cartridge (FOL)
Indications For Use:
The FOL Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of megaloblastic 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)
Carol C. Benam
Division Sign-Off
Office of In Vitre Diagnostic " Evaluation and Safe
10(k) K0712-24
9
Indications for Use
510(k) Number (if known):
Device Name: Dimension Vista® LOCI 4 Calibrator
Indications For Use:
The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of Ferritin (FERR), Vitamin B12 (B12), and Folate (FOL) methods on the Dimension Vista® system.
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)
Carol C. Benson
Division Sign-Off
Office of In Vita Cagreem Evaluation and Safety
.10(k) k67/224
Page 3 of 3
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