(147 days)
The VB12 method is an in vitro diagnostic test for the quantitative measurement of vitamin B12 in human serum and plasma on the Dimension Vista® System. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The LOCI 4 CAL is an in vitro diagnostic product for the calibration of LOCI Ferritin (FERR), LOCI Folate (FOL), and LOCI Vitamin B12 (VB12) methods on the Dimension Vista® System.
The LOCI 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 dye. The second bead reagent (Sensibead) is coated with streptavidin and contains photosensitive dye. 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.
LOCI 4 CAL is a multi-analyte liquid, frozen, product containing Ferritin from human liver, Folate, and Vitamin B12. CAL A is a HEPES buffer solution whereas CAL B - E 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.
The provided text describes the Siemens Healthcare Diagnostics Dimension Vista® LOCI Vitamin B12 Flex reagent cartridge and Dimension Vista® LOCI 4 CAL and their performance in a study to establish substantial equivalence to predicate devices.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance for the Vitamin B12 method. While explicit acceptance criteria values (e.g., "r > 0.95" as a specific target) are not definitively stated, the study's aim is to demonstrate "substantial equivalence" to a predicate device. The reported performance for precision and method comparison serves to support this claim, aligning with typical performance expectations for such diagnostic assays.
Vitamin B12 Assay Performance
| Performance Metric | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Dimension Vista® VB12 Flex) |
|---|---|---|
| Reproducibility (Precision) | Generally high precision (low %CV) expected. | |
| QC L1 (275 pg/mL) | - | Repeatability SD: 11.0, %CV: 4.0; Within-Lab SD: 19.2, %CV: 7.0 |
| QC L2 (518 pg/mL) | - | Repeatability SD: 8.2, %CV: 1.6; Within-Lab SD: 20.3, %CV: 3.9 |
| QC L3 (682 pg/mL) | - | Repeatability SD: 16.3, %CV: 2.4; Within-Lab SD: 20.1, %CV: 3.0 |
| Serum Pool 1 (238 pg/mL) | - | Repeatability SD: 8.4, %CV: 3.5; Within-Lab SD: 18.0, %CV: 7.6 |
| Li Heparin Plasma Pool (365 pg/mL) | - | Repeatability SD: 8.9, %CV: 2.4; Within-Lab SD: 12.3, %CV: 3.4 |
| Serum Pool 2 (1007 pg/mL) | - | Repeatability SD: 14.4, %CV: 1.4; Within-Lab SD: 21.0, %CV: 2.1 |
| Serum Pool 3 (1716 pg/mL) | - | Repeatability SD: 20.6, %CV: 1.2; Within-Lab SD: 32.7, %CV: 1.9 |
| Sample Type Equivalence (vs. Serum) | Correlation Coefficient (r) generally expected > 0.975-0.99 for strong equivalence; Slope near 1.0; Intercept near 0.0. | |
| Lithium Heparin Plasma | - | Slope: 0.993; Intercept: -3.2 pg/mL; r: 0.999 |
| Sodium Heparin Plasma | - | Slope: 0.995; Intercept: -3.3 pg/mL; r: 0.999 |
| EDTA Plasma | - | Slope: 0.999; Intercept: -14.4 pg/mL; r: 0.998 |
| Method Comparison (vs. Predicate) | High correlation (r) and agreement (slope near 1, intercept near 0) with predicate device. | |
| Roche Elecsys B12 System (n=162) | - | Passing-Bablok Constant: -7.64; Proportional: 0.985; Least Squares Regression R: 0.993 |
Note: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" based on these performance characteristics, which show good agreement and precision comparable to typical diagnostic assays.
2. Sample Size Used for the Test Set and Data Provenance
- Reproducibility (Precision) Test: A "single test from two independent cups was analyzed twice per day for 20 days" for each of the 7 materials (3 QC levels, 4 serum/plasma pools). This totals 2 (cups) * 2 (tests/day) * 20 (days) = 80 measurements per material. The exact number of unique patient samples for the serum/plasma pools is not specified, but they are described as "Serum Pool" or "Plasma Pool," implying pooled samples.
- Sample Type Equivalence Test: Seventy-one (71) matched serum, lithium heparin plasma, sodium heparin, and EDTA plasma samples.
- Method Comparison Test: One hundred sixty-two (162) native serum samples.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device by a major diagnostics company, it's highly probable the studies were conducted prospectively with samples collected for research purposes, likely within a regulated environment (e.g., US or EU).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The device is a quantitative immunoassay for Vitamin B12. The ground truth for such assays is typically established by the analytical method itself or by comparison to an established, validated method (the predicate device in this case) and traceable calibrators.
- Number of Experts: Not applicable in the traditional sense of expert consensus on qualitative data. The "ground truth" for the method comparison is the measurement obtained from the predicate device (Roche Elecsys Vitamin B12 Test System). For precision studies, the 'truth' is inherent to the statistical analysis of repetitive measurements.
- Qualifications of Experts: Not relevant for this type of analytical assay validation.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative assay, the results are numerical measurements from the instruments. Adjudication methods (like 2+1 or 3+1 consensus) are typically used for qualitative or subjective assessments (e.g., image interpretation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation (e.g., by radiologists, pathologists) is involved, and the AI's role is to assist human readers. This device is an automated, quantitative immunoassay.
- Effect Size of Human Readers with vs. Without AI: Not applicable.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies presented are all standalone (algorithm only) performance assessments. The device is an automated immunoassay system that provides quantitative results without human interpretation in the loop for the measurement itself. The "method comparison" directly compares the new device's standalone performance to a predicate device's standalone performance.
7. The Type of Ground Truth Used
- For Method Comparison: The ground truth was the measurements obtained from the predicate device, the Roche Elecsys® Vitamin B12 System. This represents a comparative "ground truth" for demonstrating equivalence.
- For Traceability: The calibrators are traceable to United States Pharmacopeia (USP) Grade vitamin B12, which is a form of recognized reference standard. This establishes the metrological ground truth for the measurements.
- For Precision: The ground truth is statistical, derived from repeated measurements of the same sample, indicating the variability of the device itself.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. This device is a traditional immunoassay, not an AI/ML-based diagnostic. Its performance characteristics are established through analytical validation studies rather than learning from a training dataset. The development of the assay itself would involve optimization and characterization using various analytical samples, but this is not referred to as a "training set" in the sense of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML context for this traditional immunoassay device. The assay design and calibration are based on chemical and biological principles, validated against reference materials and predicate devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and fills most of the frame. The background is plain white.
.
.
.
.
510(k) Summary Dimension Vista VB12
NOV 3 0 2012
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: _______________________________________________________________________________________________________________________________________________
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation
Manufacturer:
Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714
Contact Information:
Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Attn: A. Kathleen Ennis Tel: 302-631-9352 FAX # 302-631-6299
Date of Preparation:
· November 9, 2012
-
- Device Name Proprietary Name
- Dimension Vista® LOCI Vitamin B12 Flex reagent cartridge / Class II .
- Dimension Vista® LOCI 4 CAL / Class II, .
Common Name
- Vitamin B12 Assav ●
- Calibrator .
- FDA Classification
- Radioassay Vitamin B12 code CDD .
- Calibrator Multianalyte - code JIX .
3. Identification of the Predicate Device
FDA Guidance Document(s):
- "Bundling Multiple Devices or Multiple Indications in a Single . Submission"-11/26/2003
{1}------------------------------------------------
Device Description(s): 4.
Method
The LOCI 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 dye. The second bead reagent (Sensibead) is coated with streptavidin and contains photosensitive dye. 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.
Calibrator
LOCI 4 CAL is a multi-analyte liquid, frozen, product containing Ferritin from human liver, Folate, and Vitamin B12. CAL A is a HEPES buffer solution whereas CAL B - E 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.
Device Intended Use: 5.
Method
The VB12 method is an in vitro diagnostic test for the quantitative measurement of vitamin B12 in human serum and plasma on the Dimension Vista® System. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Calibrator
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.
6. Medical device to which equivalence is claimed:
Substantial Equivalence:
The Dimension Vista® LOCI Vitamin B12 Flex® reagent cartridge is substantially equivalent to the Roche Elecsys Vitamin B12 Test System (K060755) . The Dimension Vista® LOCI 4 Calibrator (KC640A) is substantially equivalent to the Dimension Vista® LOCI 4 Calibrator, cat.# KC640 (K071224).
{2}------------------------------------------------
Comparison to Predicate Device:
The proposed Siemens Healthcare Diagnostics Dimension Vista® VB12 method and the predicate Roche Elecsys® Vitamin B12 Test System(K060755) are both in vitro diagnostic immunoassays intended for the quantitative measurement of vitamin B12 in serum and plasma.
The Siemens Healthcare Diagnostics Dimension Vista® LOCI 4 Calibrator, cat. # KC640A, and the predicate Dimension Vista® LOC1 4 Calibrator, cat. # KC640 (K071224) are both used for the calibration of the LOCI Ferritin (FERR), LOCI Folate (FOL) and LOCI Vitamin B12 (VB12) methods on the Dimension Vista® System.
A comparison summary of the features of the products is included in the following table.
| Item | DeviceDimension Vista® VB12 Flex® reagent cartridge | PredicateRoche Elecsys Vitamin B12 Test System(K060755) |
|---|---|---|
| Similarities | ||
| Intended Use | in vitro diagnostic test for the quantitative measurement of vitamin B12 in human serum and plasma | Binding assay for the in vitro quantitative determination 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:Electrochemiluminescence Immunoassay "ECLIA" |
| Differences | ||
| Instrument | The Dimension Vista® Vitamin B12 method (VB12) is for use on the Dimension Vista® System. | The Roche Vitamin B12 Assay is for use on Elecsys and cobas e immunoassay analyzers. |
| Measuring Range | 60 - 2000 pg/mL | 30 - 2000 pg/mL |
| Lower limit of the assay | 60 pg/mL (Functional Sensitivity) | 30 pg/mL (Analytical Sensitivity) |
| Sample Size | 12 ul | 15 ul |
Method:
{3}------------------------------------------------
Calibrator:
| Item | DeviceModified LOCI 4 CAL | PredicateLOCI 4 CAL (K071224) |
|---|---|---|
| Similarities | ||
| Intended Use | The LOCI 4 CAL is an in vitrodiagnostic product for thecalibration of the LOCI Ferritin(FERR), LOCI Folate (FOL) andLOCI Vitamin B12 (VB12)methods on the DimensionVista® System. | The LOCI 4 CAL is an in vitrodiagnostic product for thecalibration of the LOCI Ferritin(FERR), LOCI Folate (FOL) andLOCI Vitamin B12 (B12)methods on the DimensionVista® System. |
| Traceability | ||
| Ferritin | Traceable to the World HealthOrganization (WHO) WHOStandard for Ferritin, 3rd IS 94/572 | Traceable to the World HealthOrganization (WHO) WHOStandard for Ferritin, 3rd IS 94/57 |
| Folate | United States PharmacopeiaGrade Folic Acid | United States PharmacopeiaGrade Folic Acid |
| Vitamin B12 | United States PharmacopeiaGrade vitamin B12 | United States PharmacopeiaGrade vitamin B12 |
| Form | Frozen Liquid | Frozen Liquid |
| Differences | ||
| Matrix | HEPES Buffer Level A2% BSA in Level B - E | BSA-based matrix Level A6% BSA in Level A - E |
| TargetConcentrationsVB12 | Level A : 45 pg/mLLevel B 200 pg/mLLevel C 500 pg/mLLevel D 1000 pg/mLLevel E: 2200 pg/mL | Level A : 0 pg/mLLevel B 200 pg/mLLevel C 500 pg/mLLevel D 1000 pg/mLLevel E: 2100 pg/mL |
| Folate | Level A: 0 ng/mLLevel B: 2.5 ng/mLLevel C: 5.0 ng/mLLevel D: 10.0 ng/mLLevel E: 21.0 ng/mL | Level A: 0 ng/mLLevel B: 2.5 ng/mLLevel C: 5.0 ng/mLLevel D: 10.0 ng/mLLevel E: 21.0 ng/mL |
| Ferritin | Level A: 0 ng/mLLevel B: 25 ng/mLLevel C: 210 ng/mLLevel D: 1050 ng/mLLevel E: 2200 ng/mL | Level A: 0 ng/mLLevel B: 25 ng/mLLevel C: 210 ng/mLLevel D: 1050 ng/mLLevel E: 2200 ng/mL |
.
{4}------------------------------------------------
Comments on Substantial Equivalence:
Method
The Siemens Healthcare Diagnostics Dimension Vista® VB12 method and the predicate Roche Elecsys Vitamin B12 Assay are both in vitro diagnostic immunoassays intended for the measurement of vitamin B12 in serum and plasma.
Reproducibility testing was conducted for the Dimension Vista® 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.
Typical precision observed for the Dimension Vista® VB12 method is summarized below:
| Material | Meanpg/mL | Repeatability | Within-Lab Precision | ||
|---|---|---|---|---|---|
| SD | %CV | SD | %CV | ||
| QC L1* | 275 | 11.0 | 4.0 | 19.2 | 7.0 |
| QC L2* | 518 | 8.2 | 1.6 | 20.3 | 3.9 |
| QC L3* | 682 | 16.3 | 2.4 | 20.1 | 3.0 |
| Serum Pool 1 | 238 | 8.4 | 3.5 | 18.0 | 7.6 |
| Li HeparinPlasma Pool | 365 | 8.9 | 2.4 | 12.3 | 3.4 |
| Serum Pool 2 | 1007 | 14.4 | 1.4 | 21.0 | 2.1 |
| Serum Pool 3 | 1716 | 20.6 | 1.2 | 32.7 | 1.9 |
*BioRad Liquichek™ Immunoassay Plus Controls, BioRad Laboratories, Irvine, CA
Seventy-one matched serum. lithium heparin plasma, sodium heparin and EDTA plasma samples were analyzed on the Dimension Vista® system. Each plasma type was analyzed versus serum. The least squares regression statistics are as follows:
| Sample Type (vs Serum)n = 71 | Slope | Interceptpg/mL | Correlation Coefficient (r) |
|---|---|---|---|
| Lithium Heparin Plasma | 0.993 | -3.2 | 0.999 |
| Sodium Heparin Plasma | 0.995 | -3.3 | 0.999 |
| EDTA Plasma | 0.999 | -14.4 | 0.998 |
A method comparison between the Dimension Vista® VB12 assay and the Vitamin B12 assay on the Roche Elecsys® System was performed with one hundred sixty-two (162) native serum samples across the proposed assay range. The samples ranged from 69 to 1829 pg/mL on the Roche Elecsys, and 60 to 1963 pg/mL on the Dimension Vista® and included thirty-two (32) samples with known Intrinsic Factor Binding Antibody (IFBA) titers ranging from 7 to 133.85 U/mL.
{5}------------------------------------------------
Passing-Bablok regression analysis of the results yielded the following:
| Bias | 95% CI | |
|---|---|---|
| Passing - Bablok Regression | ||
| Constant | -7.64 | -17.89 to -0.48 |
| Proportional | 0.985 | 0.965 to 1.004 |
The correlation coefficient, using least squares regression, for this data set (R) is 0.993
Conclusion:
The Siemens Healthcare Diagnostics Dimension Vista® VB12 method and the predicate Roche Elecsys Vitamin B12 Assay method (K060755) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products, the Siemens Healthcare Diagnostics modified Dimension Vista® LOCI 4 calibrator and the predicate Dimension Vista® LOCI 4 (K071224) are also substantially equivalent in its design and intended use with their respective assay systems.
A. Kathleen Ennis Regulatory Affairs Manager September 26, 2012
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD. 20993-002
November 30, 2012
Siemens Healthcare Diagnostics, Inc. c/o A. Kathleen B. Ennis 500 GBC Drive Newark. DE 19714
Re: K121994
Trade/Device Name: Dimension Vista® LOCI Vitamin B12 Flex reagent cartridge and Dimension Vista® LOCI 4 CAL
Regulation Number: 21 CFR 862.1810
Regulation Name: Vitamin B12 Test System
Regulatory Class: Class II Product Code: CDD, JIX
Dated: October 18, 2012
Received: October 19, 2012
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.
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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
Page 2 - A. Kathleen Ennis
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson 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
{8}------------------------------------------------
Indications for Use
510(k) Number (if known): __ K121994
Device Name: Dimension Vista® LOCI Vitamin B12 Flex reagent cartridge Dimension Vista® LOCI 4 CAL
Indications for Use: The VB12 method is an in vitro diagnostic test for the quantitative measurement of vitamin B12 in human serum and plasma on the Dimension Vista® System. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The LOCI 4 CAL is an in vitro diagnostic product for the calibration of LOCI Ferritin (FERR), LOCI Folate (FOL), and LOCI Vitamin B12 (VB12) methods on the Dimension Vista® System.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Yung Chan
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k) k 121994
Page 1 of __ 1___
§ 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.