(48 days)
No
The device description details a standard chemiluminescent immunoassay based on LOCI technology, which is a well-established laboratory technique. There is no mention of AI, ML, or any computational algorithms beyond standard data analysis for calculating results and performing statistical comparisons.
No.
This device is an in vitro diagnostic test for measuring Vitamin B12 levels, used in the diagnosis of vitamin B12 deficiency; it does not provide any therapeutic benefit.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The VB12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 (B12) in human serum and plasma... Measurements of Vitamin B12 may be used in the diagnosis of vitamin B12 deficiency."
No
The device is described as an in vitro diagnostic test utilizing chemical reagents and a chemistry system (Dimension® EXL™ with LM integrated chemistry system), indicating it involves hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the VB12 method is an "in vitro diagnostic test" for the quantitative measurement of Vitamin B12 in human serum and plasma. It also states that the LOCI ANEMIA CAL is an "in vitro diagnostic product" for calibration.
- Device Description: The description details a laboratory test that analyzes human biological samples (serum and plasma) using chemical and immunological reactions to measure a specific analyte (Vitamin B12). This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The document describes performance studies conducted on human serum and plasma samples, including method comparison with a predicate device. This type of testing is required for IVD devices to demonstrate their accuracy and reliability.
N/A
Intended Use / Indications for Use
The VB12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 (B12) in human serum and plasma on the Dimension® EXL™ with LM integrated chemistry system. Measurements of Vitamin B12 may be used in the diagnosis of vitamin B12 deficiency.
The LOCI ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI FOLA and LOCI VB12 assays on the Dimension® EXL™ with LM integrated chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
CDD, JIX
Device Description
LOCI VB12 Assay
The vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and biotinylated intrinsic factor (IF). The first bead reagent (Chemibead) is coated with a B12 derivative and contains a chemiluminescent dve. The second bead reagent (Sensibead) is coated with streptavidin and contains photosensitive dve. The patient sample is pretreated with sodium hydroxide (NaOH) and dithioerythritol (DTE) 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. Sensibead reagent is then added and binds 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.
The LOCI VB12 method reagents are packaged in an eight-well Flex® reagent cartridge as follows:
a. Wells are numbered consecutively from the wide end of the cartridge.
b. Nominal value per well in a cartridge.
Each cartridge contains a sufficient to perform 20 tests. Four (4) Flex® reagent cartridges are provided in each carton.
LOCI Anemia Calibrator
LOCI ANEMIA CAL is a multi-analyte liquid, frozen product containing Folate and Vitamin B12. All levels are prepared in a bovine serum albumin base.
The kit consists of ten vials, two each of five levels containing 2 mL per vial. Description of the manufacturing, value assignment and stability testing processes are provided.
Values are assigned to each lot of calibrator from a master pool using the Dimension® EXL with LM integrated chemistry system. The master pool is a frozen liquid, five level material, with the same composition as the calibrator with traceability to USP Grade Vitamin B12.
The assigned to LOCI Anemia Calibrator are stable for unopened frozen product until the expiration date on the label. Unopened (Thawed) product is stable for 30 days when stored at 2-8°C. Once the product is opened (cap removed), assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C. Shelf life and in use stability have been established by Siemens Healthcare through real time testing at the temperatures specified.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility Testing:
Conducted for the Dimension® LOCI VB12 method in accordance with the CLSI/NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day for 20 days. The repeatability and within-lab standard deviations were calculated by the analysis of variance method.
Sample Type Comparison (vs Serum):
A total of seventy-eight (78) matched serum, lithium heparin plasma, sodium heparin and EDTA plasma samples were analyzed on the Dimension ® EXL™ System. Of these 71 were native samples, 6 were spiked and one was diluted. Each plasma type was analyzed versus serum. Serum Separator tubes (SST) were analyzed in the same study. The Passing-Bablok regression analysis was used to analyze the data.
Method Comparison:
A method comparison between the LOCI VB12 assay on the Dimension® EXL™ with LM System and the predicate, Dimension Vista® VB12 method (K121994), was performed with 166 native human serum samples across the proposed assay range. The samples ranged from 60 - 1966 pg/mL with the Dimension Vista® VB12 method, and, 86 - 1901pq/mL with the LOCI® VB12 assay on the Dimension® EXL™ with LM integrated chemistry system. These samples included thirty-five (35) samples that were positive for Intrinsic Factor Blocking Antibody (IFBA) with titers ranging from 15 - 164 IU/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reproducibility:
- Bio-Rad Liquichek® Immunoassay Control L1: Mean 290 pg/mL, Repeatability SD 13.2, %CV 4.6, Within-Lab Precision SD 15.0, %CV 5.2
- Bio-Rad Liquichek® Immunoassay Control L2: Mean 498 pg/mL, Repeatability SD 11.7, %CV 2.3, Within-Lab Precision SD 18.2, %CV 3.7
- Bio-Rad Liquichek® Immunoassay Control L3: Mean 645 pg/mL, Repeatability SD 15.9, %CV 2.5, Within-Lab Precision SD 21.5, %CV 3.3
- Serum Pool 1: Mean 180 pg/mL, Repeatability SD 10.1, %CV 5.6, Within-Lab Precision SD 11.6, %CV 6.5
- Li Heparin Plasma Pool: Mean 467 pg/mL, Repeatability SD 13.1, %CV 2.8, Within-Lab Precision SD 15.8, %CV 3.4
- Serum Pool 2: Mean 978 pg/mL, Repeatability SD 24.9, %CV 2.5, Within-Lab Precision SD 27.7, %CV 2.8
- Serum Pool 3: Mean 1733 pg/mL, Repeatability SD 27.4, %CV 1.6, Within-Lab Precision SD 35.2, %CV 2.0
Sample Type Comparison (Passing-Bablok Regression Analysis):
- Lithium Heparin Plasma (n = 78): Slope 1.00 (95% CI 0.99 - 1.02), Intercept -4.33 pg/mL (95% CI -13.4 to +2.5)
- Sodium Heparin Plasma (n = 78): Slope 1.02 (95% CI 0.99 - 1.04), Intercept -10.73 pg/mL (95% CI -20.2 to -0.4)
- EDTA Plasma (n = 78): Slope 1.00 (95% CI 0.98 - 1.02), Intercept -7.26 pg/mL (95% CI -15.8 to +3.5)
- SST Tubes (n = 78): Slope 1.01 (95% CI 0.99 - 1.03), Intercept -2.31 pg/mL (95% CI 12.0 to +6.3)
Method Comparison (Passing-Bablok Regression Analysis):
- Intercept (pg/mL): -6.37 (95% CI -12.90 to 0.36)
- Slope: 1.03 (95% CI 1.02 to 1.04)
- Correlation coefficient (least squares regression): r = 0.997
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
510(k) Summary
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:
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Contact Information:
Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714
Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Attn: A. Kathleen Ennis Regulatory Affairs Manager Tel: 302-631-9352 FAX # 302-631-6299
Date of Preparation:
December 30, 2013
2. Device Name
Proprietary Name
- . LOCI Vitamin B12 Flex® reagent cartridge
- LOCI Anemia Calibrator .
- Common Name
- Vitamin B12 Assay .
- Calibrator ●
- FDA Classification
- Radioassay Vitamin B12 code CDD ●
- Calibrator Multianalyte - code JIX .
3. Identification of the Predicate Device
- . Dimension Vista® Vitamin B12 Flex® reagent cartridge (VB12) K121994
- Dimension Vista® LOCI 4 CAL K121994 .
FDA Guidance Document(s):
- "Bundling Multiple Devices or Multiple Indications in a Single ● Submission" - 11/26/2003
1
Device Description(s): 4.
LOCI VB12 Assav
The vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and biotinylated intrinsic factor (IF). The first bead reagent (Chemibead) is coated with a B12 derivative and contains a chemiluminescent dve. The second bead reagent (Sensibead) is coated with streptavidin and contains photosensitive dve. The patient sample is pretreated with sodium hydroxide (NaOH) and dithioerythritol (DTE) 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. Sensibead reagent is then added and binds 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.
| Wellsa | Form | Ingredient | Concentrationb | Source |
|---|---|---|---|---|
| 1 | Liquid | VB12 Sensibead reagent | 360 µg/mL | Recombinant E. coli |
| 2 | Liquid | VB12-Chemibead reagent | 200 µg/mL | |
| 3 | empty | |||
| 4 | Liquid | Biotinylated IF | 3 ng/mL | porcine |
| Dicyanocobinimide | 60 ng/mL | |||
| 5 | Tablet | Dithioerythritol (DTE) | 12.5 mg/mL | |
| 6 | Liquid | Sodium Hydroxide (NaOH) | 0.75 N | |
| Potassium Cyanide (KCN) | 3 mM | |||
| 7-8 | empty |
The LOCI VB12 method reagents are packaged in an eight-well Flex® reagent cartridge as follows:
a. Wells are numbered consecutively from the wide end of the cartridge.
b. Nominal value per well in a cartridge.
Each cartridge contains a sufficient to perform 20 tests. Four (4) Flex® reagent cartridges are provided in each carton.
LOCI Anemia Calibrator
LOCI ANEMIA CAL is a multi-analyte liquid, frozen product containing Folate and Vitamin B12. All levels are prepared in a bovine serum albumin base.
2
The kit consists of ten vials, two each of five levels containing 2 mL per vial. Description of the manufacturing, value assignment and stability testing processes are provided.
Values are assigned to each lot of calibrator from a master pool using the Dimension® EXL with LM integrated chemistry system. The master pool is a frozen liquid, five level material, with the same composition as the calibrator with traceability to USP Grade Vitamin B12.
The assigned to LOCI Anemia Calibrator are stable for unopened frozen product until the expiration date on the label. Unopened (Thawed) product is stable for 30 days when stored at 2-8°C. Once the product is opened (cap removed), assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C. Shelf life and in use stability have been established by Siemens Healthcare through real time testing at the temperatures specified.
5. Device Intended Use:
LOCI VB12 Assay
The VB12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 (B12) in human serum and plasma on the Dimension® EXL™ with LM integrated chemistry system. Measurements of Vitamin B12 may be used in the diagnosis of vitamin B12 deficiency.
LOCI Anemia Calibrator
The LOCI ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI FOLA and LOCI VB12 assays on the Dimension® EXL™ with LM integrated chemistry system.
6. Medical device to which equivalence is claimed:
Substantial Equivalence:
The LOCI Vitamin B12 Flex® reagent cartridge (RF642) is substantially equivalent to the Dimension Vista® Vitamin B12 method (k#121994). The LOCI Anemia Calibrator (RC640) is substantially equivalent to the LOCI 4 Calibrator, cat.# KC640A (k#121994).
Comparison to Predicate Device:
The proposed Siemens Healthcare Diagnostics LOCI VB12 method and the predicate Dimension Vista® VB12 method (K121994) are both in vitro diagnostic immunoassays intended for the quantitative measurement of vitamin B12 in serum and plasma.
The Siemens Healthcare Diagnostics LOCI Anemia Calibrator, cat, # RC640 and the predicate Siemens LOCI 4 Calibrator, cat. # KC640A (K121994) are both used for the calibration of Folate and Vitamin B12 methods.
A comparison summary of the features of the products is included in the following table.
3
LOCI VB12 Assay:
:
| Item | Device
LOCI Vitamin B12 Flex®
reagent cartridge | Predicate
Dimension Vista® Vitamin
B12 Flex® reagent cartridge
(K121994) |
|-----------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | in vitro diagnostic test for the
quantitative measurement of
vitamin B12 in human serum
and plasma | in vitro diagnostic test for the
quantitative measurement of
vitamin B12 in human serum
and plasma |
| Sample Types | Serum and Plasma | Serum and Plasma |
| Measurement
method | Chemiluminescent:
Homogenous sandwich
immunoassay based on LOCI®
technology | Chemiluminescent:
Homogenous sandwich
immunoassay based on LOCI®
technology |
| Sample Size | 12 uL | 12 uL |
| Differences | | |
| Instrument | The Dimension® EXL™ with
LM System | The Dimension Vista® System. |
| Measuring Range | 80 - 2000 pg/mL | 60 - 2000 pg/mL |
4
LOCI Anemia Calibrator:
| Item | Device
LOCI Anemia Calibrator
(ANEM CAL) | Predicate
LOCI 4 Calibrator
(K121994) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The LOCI ANEM CAL is an in
vitro diagnostic product for the
calibration of the LOCI FOLA
and LOCI VB12 assays on the
Dimension® EXLT™ with LM
System. | The LOCI 4 CAL is an in vitro
diagnostic product for the
calibration of the LOCI Ferritin
(FERR), LOCI Folate (FOL) and
LOCI Vitamin B12 (VB12)
methods on the Dimension
Vista® System. |
| Traceability | | |
| Folate | United States Pharmacopeia
Grade Folic Acid | United States Pharmacopeia
Grade Folic Acid |
| Vitamin B12 | United States Pharmacopeia
Grade vitamin B12 | United States Pharmacopeia
Grade vitamin B12 |
| Form | Frozen Liquid | Frozen Liquid |
| Target
Concentrations
VB12 | Level 1 : 45 pg/mL
Level 2 200 pg/mL
Level 3 500 pg/mL
Level 4 1000 pg/mL
Level 5: 2200 pg/mL | Level A: 45 pg/mL
Level B: 200 pg/mL
Level C: 500 pg/mL
Level D: 1000 pg/mL
Level E: 2200 pg/mL |
| Folate | Level 1: 0 ng/mL
Level 2: 2.5 ng/mL
Level 3: 5.0 ng/mL
Level 4: 10.0 ng/mL
Level 5: 21.0 ng/mL | Level A: 0 ng/mL
Level B: 2.5 ng/mL
Level C: 5.0 ng/mL
Level D: 10.0 ng/mL
Level E: 21.0 ng/mL |
| Differences | | |
| Matrix | bovine serum albumin base in
levels 1 - 5 | HEPES buffer Level A
bovine serum base (BSA) in
levels B - E |
| Constituents | LOCI ANEM CAL is assigned for
vitamin B12 and Folate. | LOCI 4 CAL is assigned for
vitamin B12, Folate and Ferritin |
5
Comments on Substantial Equivalence:
Method
The Siemens Healthcare Diagnostics Dimension® LOCI VB12 method and the predicate Siemens Healthcare Diagnostics Dimension Vista® LOCI VB12 method (K121994) are both in vitro diagnostic immunoassays intended for the measurement of vitamin B12 in serum and plasma.
Reproducibility testing was conducted for the Dimension® LOCI VB12 method in accordance with the CLSI/NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day for 20 days. The repeatability and within-lab standard deviations were calculated by the analysis of variance method.
| Material | Mean
pg/mL | Repeatability | | Within-Lab Precision | |
|--------------------------------------------|---------------|---------------|-----|----------------------|-----|
| | | SD | %CV | SD | %CV |
| Bio-Rad Liquichek® Immunoassay
Control* | | | | | |
| L1 | 290 | 13.2 | 4.6 | 15.0 | 5.2 |
| L2 | 498 | 11.7 | 2.3 | 18.2 | 3.7 |
| L3 | 645 | 15.9 | 2.5 | 21.5 | 3.3 |
| Serum Pool 1 | 180 | 10.1 | 5.6 | 11.6 | 6.5 |
| Li Heparin Plasma
Pool | 467 | 13.1 | 2.8 | 15.8 | 3.4 |
| Serum Pool 2 | 978 | 24.9 | 2.5 | 27.7 | 2.8 |
| Serum Pool 3 | 1733 | 27.4 | 1.6 | 35.2 | 2.0 |
Typical precision observed for the Dimension® LOCI VB12 method is summarized below:
*BioRad Liquichek™ Immunoassay Plus Controls, BioRad Laboratories, Irvine, CA
A total of seventy-eight (78) matched serum, lithium heparin plasma, sodium heparin and EDTA plasma samples were analyzed on the Dimension ® EXL™ System. Of these 71 were native samples, 6 were spiked and one was diluted. Each plasma type was analyzed versus serum. Serum Separator tubes (SST) were analyzed in the same study. The Passing-Bablok regression analysis was used to analyze the data. The results are as follows:
| Sample Type (vs Serum)
n = 78 | Slope | 95%
Confidence
Interval | Intercept
pg/mL | 95%
Confidence
Interval pg/mL |
|----------------------------------|-------|-------------------------------|--------------------|-------------------------------------|
| Lithium Heparin Plasma | 1.00 | 0.99 - 1.02 | -4.33 | -13.4 to +2.5 |
| Sodium Heparin Plasma | 1.02 | 0.99 - 1.04 | -10.73 | -20.2 to -0.4 |
| EDTA Plasma | 1.00 | 0.98 - 1.02 | -7.26 | -15.8 to +3.5 |
| SST Tubes | 1.01 | 0.99 - 1.03 | -2.31 | 12.0 to +6.3 |
6
A method comparison between the LOCI VB12 assay on the Dimension® EXL™ with LM System and the predicate, Dimension Vista® VB12 method (K121994), was performed with 166 native human serum samples across the proposed assay range. The samples ranged from 60 - 1966 pg/mL with the Dimension Vista® VB12 method, and, 86 - 1901pq/mL with the LOCI® VB12 assay on the Dimension® EXL™ with LM integrated chemistry system. These samples included thirty-five (35) samples that were positive for Intrinsic Factor Blocking Antibody (IFBA) with titers ranging from 15 - 164 IU/mL.
Passing-Bablok regression analysis of the results yielded the following:
| Passing & Bablok Regression | ||
|---|---|---|
| Bias | 95% CI | |
| Intercept(pg/mL) | -6.37 | -12.90 to 0.36 |
| Slope | 1.03 | 1.02 to 1.04 |
The correlation coefficient, using least squares regression, for this data set (r) is 0.997.
Conclusion:
The Siemens Healthcare Diagnostics LOCI VB12 method and the predicate Siemens Healthcare Diagnostics Dimension Vista® VB12 method (K121994) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products, the Siemens Healthcare Diagnostics LOCI Anemia Calibrator and the predicate Dimension Vista® LOCI 4 Calibrator (K121994) are also substantially equivalent in its design and intended use with their respective assay systems.
Anna Marie K. Ennis Requlatory Affairs Manager December 30 2013
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2014
SIEMENS HEALTHCARE DIAGNOSTICS ANNA MARIE KATHLEEN ENNIS P.O. Box 6101 500 GBC DRIVE M/S 514 NEWARK DE 19714-6101
Re: K133512
Trade/Device Name: LOCI Vitamin B12 Flex® Reagent Cartridge and LOCI Anemia Calibrator
Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: II Product Code: CDD, JIX Dated: November 5, 2013 Received: November 15, 2013
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
8
Page 2-Ms. Ennis
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K133512
Device Name: LOCI vitamin B12 Flex® Reagent Cartridge and LOCI Anemia Calibrator
Indications for Use:
The VB12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 (B12) in human serum and plasma on the Dimension® EXL™ with LM integrated chemistry system. Measurements of Vitamin B12 may be used in the diagnosis of vitamin B12 deficiency.
The LOCI ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI FOLA and LOCI VB12 assays on the Dimension® EXL™ with LM integrated chemistry system.
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 Diagnostics and Radiological Health (OIR)
YungFDAban-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K133512