(80 days)
Not Found
No
The device description details a standard 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.
No.
The device is described as an "in vitro diagnostic device" used for the quantitative measurement of Vitamin B12 and Folate in human samples, which falls under diagnostics, not therapeutics.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from the B12 Flex and FOL Flex reagent cartridges are "used in the diagnosis and treatment of anemias of the gastrointestinal malabsorption" and "used in the diagnosis and treatment of megaloblastic anemia" respectively. Furthermore, the "Device Description" section clearly labels both the B12 and FOL methods as "an in vitro diagnostic device."
No
The device description clearly outlines physical components (reagent cartridges, beads, dyes) and chemical processes, 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 description explicitly states that the reagent cartridges are "in vitro products for the quantitative measurement of Vitamin B12 in human serum and plasma" and "in vitro product for the quantitative measurement of Folate in human serum." It also mentions their use in the "diagnosis and treatment of anemias of the gastrointestinal malabsorption" and "diagnosis and treatment of megaloblastic anemia." This clearly indicates the device is intended for use outside of the body to examine specimens from the human body for the purpose of providing information for diagnosis.
- Device Description: The description details the reagents and the process used to measure Vitamin B12 and Folate in human samples (serum and plasma). This aligns with the nature of an in vitro diagnostic device.
- Performance Studies: The document describes performance studies conducted using human serum samples, comparing the device to predicate devices. This is typical for IVD submissions.
- Predicate Devices: The listed predicate devices are also described as "Flex Reagent Cartridge," further supporting the classification as an IVD.
The entire document describes a product designed to perform tests on human biological samples in vitro to aid in medical diagnosis and treatment, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The B12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension EXL™ integrated chemistry system.
The FOL method is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension EXL ™ integrated chemistry system.
The B12 Flex® reagent cartridge is an in vitro product for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension® EXI" integrated chemistry system. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of the gastrointestinal malabsorption.
The FOL Flex® reagent cartridge is an in vitro product for the quantitative measurement of Folate in human serum on the Dimension® EXL™ integrated chemistry system. Measurements of folate are used in the diagnosis and treatment of megaloblastic anemia
Product codes (comma separated list FDA assigned to the subject device)
CDD, CGN
Device Description
B12: The B12 method is an in vitro diagnostic device that consists of pre-packaged reagents in a plastic eight well cartridge for use on the Dimension EXL™ integrated chemistry svstem.
The vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCl® technology. LOCI® 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 Sodium Hydroxide (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.
Folate: The FOL method is an in vitro diagnostic device that consists of pre-packaged reagents in a plastic eight well cartridge for use on the Dimension EXL™ integrated chemistry svstem.
The Folate method is a homogeneous, competitive chemiluminescent immunoassay based on LOCI® technology. LOCI® 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 Sodium Hydroxide (NaOH) and Dithioerythritol (DTE) to release serum folate from endogenous folate binding protein (FBP) and to maintain 5-methyltetrahydrofolate 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.
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)
A split sample method comparison was conducted using the Dimension® B12 Flex® reagent cartridge vs. the Dimension Vista® B12 Flex® reagent cartridge. Two hundred and thirty- three (233) human serum samples ranging from 68 to 1920 pg/mL were used. The data was analyzed using least squares linear regression. The analysis is as follows:
Slope = 0.98
y-intercept = 19.0 per/mL
r = 0.995
n = 233
A split sample method comparison was conducted using the Dimension® FOL Flex® reagent cartridge vs. the Dimension Vista® FOL Flex® reagent cartridge. One hundred and thirty- eight (138) human serum samples ranging from 0.6 to 19.2 ng/mL were . used. The data was analyzed using least squares linear regression. The analysis is as follows:
Slope= 1.01
y-intercept = 0.05 ng/mL
r = 0.99
n = 138
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1810 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
FEB 1 2 2010
510(k) Summary for Dimension® EXL™ B12 and Dimension® EXL™ FOL Methods
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.
The assigned 510(k) number is: _ 15 093 3 1
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | Siemens Healthcare Diagnostics Inc
Newark, Delaware 19714-6101 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Siemens Healthcare Diagnostics Inc.
500 GBC Drive
P.O. Box 6101
Newark, Delaware 19714-6101
Attn: A. Kathleen Ennis
Tel: 302-631-9352
Fax: 302-631-6299 |
November 17, 2009 Preparation date:
2. Device Name:
| B12 Flex® Reagent Cartridge | |
|---|---|
| Classification: | Class II |
| Product Code: | CDD |
| Panel: | Clinical Chemistry (75) |
FOL Flex® Reagent Cartridge Classification: Class II Product Code: CGN Clinical Chemistry (75) Panel:
Identification of the Legally Marketed Device: 3.
Dimension Vista® B12 Flex Reagent Cartridge - K071224 Dimension Vista® Folate Flex Reagent Cartridge - K071224
CONFIDENTIAL
1
Device Descriptions: 4.
B12
The B12 method is an in vitro diagnostic device that consists of pre-packaged reagents in a plastic eight well cartridge for use on the Dimension EXL™ integrated chemistry svstem.
The vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCl® technology. LOCI® 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 Sodium Hydroxide (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.
Folate
The FOL method is an in vitro diagnostic device that consists of pre-packaged reagents in a plastic eight well cartridge for use on the Dimension EXL™ integrated chemistry svstem.
The Folate method is a homogeneous, competitive chemiluminescent immunoassay based on LOCI® technology. LOCI® 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 Sodium Hydroxide (NaOH) and Dithioerythritol (DTE) to release serum folate from endogenous folate binding protein (FBP) and to maintain 5-methyltetrahydrofolate 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.
5. Device Intended Uses:
The B12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension EXL™ integrated chemistry system.
The FOL method is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension EXL ™ integrated chemistry system.
CONFIDENTIAL
2
Siemens Healthcare Diagnostics Inc. B12 and Folate Special 510(k) Notification
Summary of the devices technological characteristics 6.
The Dimension B12 Flex® reagent cartridge has the same technological characteristics as the Dimension Vista ® B12 Flex reagent cartridge. A comparison of features is provided.
| Feature | Predicate Device: | New Device: |
|---|---|---|
| Dimension Vista® B12 Flex® | ||
| reagent cartridge (K071244) | Dimension® B12 Flex® | |
| reagent cartridge | ||
| Intended Use | Both test systems are for in vitro diagnostic use for the | |
| quantitative measurement of B12 in human serum and plasma. | Both test systems are for in vitro diagnostic use for the | |
| quantitative measurement of B12 in human serum and plasma. | ||
| Sample Type | Both devices are for use with human serum and plasma. | Both devices are for use with human serum and plasma. |
| Analytical Measuring | ||
| Range | The Dimension Vista® B12 | |
| method has an assay range of | ||
| 50 - 2000 pg/mL | The Dimension® B12 method | |
| has an assay range of 56 – | ||
| 2000 pg/mL | ||
| Technology | Both devices use LOCI® technology. | Both devices use LOCI® technology. |
| Sample size | Uses 15 µL of serum or | |
| plasma and has a dilution ratio | ||
| of 1:11 in the extracting step. | Uses 12 µL of serum or | |
| plasma and has a dilution ratio | ||
| of 1:10 in the extracting step. | ||
| Reagents | Both systems use the same reagents. | Both systems use the same reagents. |
| Instrument | The Dimension Vista® B12 | |
| Flex® is run on the Dimension | ||
| Vista® System. | The Dimension® B12 Flex® is | |
| run on the Dimension® EXL | ||
| integrated chemistry System. |
The Dimension FOL Flex® reagent cartridge has the same technological characteristics as the Dimension Vista ® FOL Flex reagent cartridge. A comparison of features is provided.
| Feature | Predicate Device: | New Device: |
|---|---|---|
| Dimension Vista® FOL Flex® | ||
| reagent cartridge (K071244) | Dimension® FOL Flex® | |
| reagent cartridge | ||
| Intended Use | Both test systems are for in vitro diagnostic use for the | |
| quantitative measurement of FOL in human serum and plasma. | Both test systems are for in vitro diagnostic use for the | |
| quantitative measurement of FOL in human serum and plasma. | ||
| Sample Type | Both devices are for use with human serum and heparinized | |
| plasma. | Both devices are for use with human serum and heparinized | |
| plasma. | ||
| Analytical Measuring | ||
| Range | The analytical measuring range for both methods is 0.5 – 20 ng/mL | The analytical measuring range for both methods is 0.5 – 20 ng/mL |
| Technology | Both devices use LOCI® technology. | Both devices use LOCI® technology. |
| Sample size | Both methods use 10 µL of sample. | Both methods use 10 µL of sample. |
| Reagents | Both systems use the same liquid reagents and has the same | |
| reaction concentrations for all reagents. | Both systems use the same liquid reagents and has the same | |
| reaction concentrations for all reagents. | ||
| The Dimension Vista® FOL | ||
| Flex® uses four (4), 70 mg | ||
| tablets per well which contain | ||
| a total of 26 mg of DTE. | The Dimension FOL Flex® | |
| uses one (1), 95 mg tablet per | ||
| well which contains 26 mg of | ||
| DTE. | ||
| Instrument | The Dimension Vista® FOL | |
| Flex® is run on the Dimension | ||
| Vista® System. | The Dimension® FOL Flex® is | |
| run on the Dimension® EXL | ||
| integrated chemistry System. |
7. Method Comparison
A split sample method comparison was conducted using the Dimension® B12 Flex® reagent cartridge vs. the Dimension Vista® B12 Flex® reagent cartridge. Two hundred and thirty- three (233) human serum samples ranging from 68 to 1920 pg/mL were used.
3
The data was analyzed using least squares linear regression. The analysis is as follows:
$$\mathsf{Slope} = \mathtt{0.98} \ \mathsf{y-intercept} = \mathtt{19.0} \text{ рэр/и} \ \mathsf{r} = \mathtt{0.995} \ \mathsf{n} = \mathtt{233}$$
A split sample method comparison was conducted using the Dimension® FOL Flex® reagent cartridge vs. the Dimension Vista® FOL Flex® reagent cartridge. One hundred and thirty- eight (138) human serum samples ranging from 0.6 to 19.2 ng/mL were . used. The data was analyzed using least squares linear regression. The analysis is as follows:
Slope= 1.01 y-intercept = 0.05 ng/mL r = 0.99 n = 138
-
- Conclusion
Based on a review of the devices technological features and the method comparison study, the Dimension® B12 Flex® reagent cartridge is substantially equivalent to the legally marketed device, the Dimension Vista® B12 Flex® reagent cartridge.
- Conclusion
Based on a review of the devices technological features and the method comparison study, the Dimension® FOL Flex® reagent cartridge is substantially equivalent to the leqally marketed device, the Dimension Vista® FOL Flex® reagent cartridge.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a stylized eagle-like symbol. The text is arranged in a circular fashion around the symbol. The symbol itself is composed of three curved lines that resemble a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics Inc. c/o Anna Marie Kathleen Ennis Regulatory Affairs Technical Specialist 500 GBC Drive, P.O. Box 6101 Newark, DE 19714, USA
FEB 1 2 2010
Re: K093631 Trade/Device Name: Dimension® B12 Flex® Reagent Cartridge and Dimension® FOL Flex® Reagent Cartridge Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 Test System Regulatory Class: Class II Product Code: CDD and CGN Dated: January 15, 2009 Received: January 19, 2009
Dear Ms. Ennis
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 arior 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 thorers) maisions 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 I loast of advised that sour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of a comply with all r coolur statues and regularing, but not limited to: registration and listing (21 CFR Part 807); the rece of equirements, and 809); and 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) This letter will anow you to began maine of substantial equivalence of your device to a legally premarket notification. The PDF Michig sification for your device and thus, permits your device to proceed to the market.
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, 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 Form
K093631 510(k) Number (if known):
Dimension® B12 Flex® reagent cartridge Device Name:
Indications for Use:
The B12 Flex® reagent cartridge is an in vitro product for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension® EXI" integrated chemistry system. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of the gastrointestinal malabsorption.
ХХ Over-The-Counter Use Prescription Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carl Benarr
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K09 3631
Page 1 of 2
7
Indications for Use Form
K093631 510(k) Number (if known):
Device Name: _ Dimension® FOL Flex® reagent cartridge_
Indications for Use:
The FOL Flex® reagent cartridge is an in vitro product for the quantitative measurement of Folate in human serum on the Dimension® EXL™ integrated chemistry system. Measurements of folate are used in the diagnosis and treatment of megaloblastic anemia
Prescription Use ХХХХ Over-The-Counter Use Prescription Ose -------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093631
Page 2 of 2