Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard chemiluminescent immunoassay (CLIA) for measuring Vitamin B12. There is no mention of AI, ML, or any computational methods beyond basic signal processing and quantitative analysis of the chemiluminescent signal. The performance studies are standard analytical validation methods for an immunoassay.

Therapeutic

No
This device is an in vitro diagnostic (IVD) assay designed to measure Vitamin B12 levels, which are then used to aid in the diagnosis and treatment of anemia. It does not directly provide a therapeutic effect or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that "Measurements obtained by this device are used in the diagnosis and treatment of anemia's of gastrointestinal malabsorption." This directly indicates its use for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device is a chemiluminescent immunoassay (CLIA) which is a laboratory test involving chemical reactions and physical components (reagents, analyzer) to measure Vitamin B12. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of Vitamin B12 in human serum, SST serum and lithium heparin plasma." It also states that the measurements are "used in the diagnosis and treatment of anemia's of gastrointestinal malabsorption." This clearly indicates the device is used to test samples taken from the human body in vitro (outside the body) to provide information for diagnosis and treatment.
Device Description: The description details a "competitive chemiluminescence immunoassay (CLIA)" performed on "human serum, SST serum and lithium heparin plasma." This further confirms the testing of biological samples outside the body.
Performance Studies: The performance studies describe testing of "samples," "patient sets," and "serum samples," all of which are biological specimens.

The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help diagnose diseases or conditions. This device fits that definition perfectly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DiaSorin LIAISON® Vitamin B12 assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Vitamin B12 in human serum, SST serum and lithium heparin plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemia's of gastrointestinal malabsorption. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.

The assay must be performed on the LIAISON® XL Analyzer.

Product codes

CDD

Device Description

The LIAISON® Vitamin B12 assay is a competitive chemiluminescence immunoassay (CLIA) for quantitative determination of Vitamin B12 is serum. SST serum and lithium heparin plasma. During the first incubation, Vitamin B12 is dissociated from its binding protein. After the initial incubation of 10.5 minutes. Vitamin B12 binds to an intrinsic factor on the solid phase. After a second incubation of 10.5 minutes, a Vitamin B12 linked to an isoluminol derivative is added to compete with the Vitamin B12 in the sample. After a third incubation of 5.25 minutes, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added to initiate a flash chemiluminescent reaction. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of Vitamin B12 present in calibrators, controls, or samples.

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

The reference range study was performed with serum samples from 166 apparently healthy adults aged 21 - 59 years of age.

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)

Method Comparison: 155 samples spanning the assay range were tested by the LIAISON® Vitamin B12 and by another commercially available method following CLSI EP09-A3. Results: LIAISON® Vitamin B12 = 0.97 (Reference Method) + 6.25; R = 0.985.
Sample Matrix Comparison: 48 matched patient sets of serum, SST serum and lithium heparin plasma samples were tested.
Sample Equivalence SST serum compared to Serum: Constant Bias = 8.21 (95% CI: 2.14 to 16.56), Proportional Bias = 0.97 (95% CI: 0.94 to 0.99), R2 = 0.996.
Sample Equivalence Lithium Heparin compared to Serum: Constant Bias = 14.78 (95% CI: 1.09 to 29.87), Proportional Bias = 1.10 (95% CI: 1.05 to 1.15), R2 = 0.988.
Reference Range: Prospectively collected serum samples from 166 apparently healthy adults aged 21-59 were used. Observed Range (2.5th to 97.5th Percentile) = 107.2 pg/mL – 653.3 pg/mL, Median = 318.5 pg/mL.
Precision: One lot of kit controls and six serum samples were tested twice per day in duplicate over 20 operating days according to CLSI EP5-A3. Total Within One Lot and Site %CV ranged from 6.7% to 10.0%.
Linearity: One high sample of each specimen type (serum, lithium heparin plasma) was diluted and tested following CLSI EP6-A.
Serum: Observed Vitamin B12 = 1.076x + 6.896; R = 0.998.
SST Serum: Observed Vitamin B12 = 1.009x + 0.224; R = 0.999.
Lithium Heparin plasma: Observed Vitamin B12 = 1.029x - 0.095; R = 0.996.
Recovery Study: Five high and five low concentration serum samples were analyzed. Mean Recovery = 100%.
Analytical Specificity - Cross-Reactivity Studies: Dicyanocobinamide (10,000 pg/mL) showed -0.19% cross-reactivity.
Interference Studies: No interference was demonstrated from various substances at the highest tested concentrations.
Limit of Blank, Limit of Detection and Limit of Quantitation: LoB

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

October 2, 2019

DiaSorin Inc. Mari Meyer Regulatory Affairs Specialist 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082-0285

Re: K192064

Trade/Device Name: LIAISON® Vitamin B12 Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: II Product Code: CDD Dated: July 31, 2019 Received: August 5, 2019

Dear Mari Meyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192064

Device Name LIAISON® Vitamin B12

Indications for Use (Describe)

The DiaSorin LIAISON® Vitamin B12 assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Vitamin B12 in human serum, SST serum and lithium heparin plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemia's of gastrointestinal malabsorption. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.

The assay must be performed on the LIAISON® XL Analyzer.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

LIAISON® Vitamin B12

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

1. 510(k) Number: K192064

Applicant: Mari Meyer DiaSorin Inc. 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 Office Number: 651-351-5635; Fax Number: 651-351-5669 Email: mari.meyer@diasorin.com
Date: September 25, 2019

4. Proprietary and Established Names:

LIAISON® Vitamin B12

5. Requlatorv Information:

LIAISON® Vitamin B12

Regulation Section: 21 CFR 862.1810 Classification: Class II Product Code: CDD Panel: Clinical Chemistry (75)

6. Predicate Device(s):

The predicate device used to demonstrate substantial equivalence to the LIAISON® Vitamin B12 assay is the Beckman Coulter Access Vitamin B12 assay previously FDA cleared under (K140496).

7. Device Description:

The LIAISON® Vitamin B12 assay is a competitive chemiluminescence immunoassay (CLIA) for quantitative determination of Vitamin B12 is serum. SST serum and lithium heparin plasma. During the first incubation, Vitamin B12 is dissociated from its binding protein. After the initial incubation of 10.5 minutes. Vitamin B12 binds to an intrinsic factor on the solid phase. After a second incubation of 10.5 minutes, a Vitamin B12 linked to an isoluminol derivative is added to compete with the Vitamin B12 in the sample. After a third incubation of 5.25 minutes, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added to initiate a flash chemiluminescent reaction. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of Vitamin B12 present in calibrators, controls, or samples.

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8. Intended Use:

The DiaSorin LIAISON® Vitamin B12 assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Vitamin B12 in human serum, SST serum and lithium heparin plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemia's of gastrointestinal malabsorption. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.

The assay must be performed on the LIAISON® XL Analyzer.

9. Indication(s) for Use:

Same as Intended Use

10. Substantial Equivalence Information:

A comparison of the similarities and differences between the LIAISON® Vitamin B12 assay and the predicate Beckman Coulter Access Vitamin B12 assay is provided in the following table:

Assay Similarities and Differences
Characteristic	Candidate Device
LIAISON® Vitamin B12	Predicate Device
Beckman Coulter Access
Vitamin B12 (K140496)
Intended Use	The DiaSorin LIAISON® Vitamin
B12 assay uses chemiluminescent
immunoassay (CLIA) technology
for the quantitative determination
of Vitamin B12 in human serum,
SST serum and lithium heparin
plasma. Measurements obtained
by this device are used in the
diagnosis and treatment of
anemia's of gastrointestinal
malabsorption. Assay results
should be used in conjunction with
other clinical or laboratory data to
assist the clinician in making
individual patient management
decisions.
The assay must be performed on
the LIAISON® XL Analyzer.	The Access Vitamin B12
assay is a paramagnetic
particle, chemiluminescent
immunoassay for the
quantitative determination of
vitamin B12 levels in human
serum and plasma (heparin)
using the Access
Immunoassay Systems.
Measured Analyte	Vitamin B12	Same
Assay Type	Chemiluminescence
immunoassay	Same
Results	Quantitative	Same

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| Characteristic | Candidate Device
LIAISON® Vitamin B12 | Predicate Device
Beckman Coulter Access
Vitamin B12 (K140496) |
|-------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Sample Type | Human serum, SST serum and
lithium heparin plasma | Human serum and heparin
plasma |
| Sample Size | 100 µL | 45 µL |
| Storage | 2-8°C | 2-10°C |
| Operating
Principle | Automated Chemiluminescent
Immunoassay (CLIA) | Same |
| Solid Phase | Magnetic particles coated intrinsic
factor | Paramagnetic particles coated
with goat anti-mouse IgG |
| Conjugate | Proprietary polymer conjugated
with Vitamin B12 and an
isoluminol derivative,
in MES buffer | Porcine intrinsic factor-alkaline
phosphate (bovine) conjugate
in TRIS buffered saline |
| Analytical
Measuring Range | 55 - 1500 pg/mL | 50 -1500 pg/mL |
| Calibrators | 2 Levels, on board | 5 Levels |

11. Standard/guidance Document Reference:

CLSI Guideline EP5-A3, Evaluation of Precision of Quantitative Measurement o Procedures; Approved Guideline.
CLSI Guideline EP15-A3, User Verification of Precision and Estimation of Bias; O Approved Guideline.
CLSI Guideline EP EP07-A2, Interference Testing in Clinical Chemistry, O Approved Guideline.
CLSI Guideline EP06-A, Evaluation of the Linearity of Quantitative Measurement O Procedures: A Statistical Approach; Approved Guideline.
CLSI Guideline EP 17-A2, Evaluation of Detection Capability for Clinical o Laboratory Measurement Procedures; Approved Guideline.
CLSI Guideline EP09-A3, Measurement Procedure Comparison and Bias O Estimation Using Patient Samples; Approved Guideline.
CLSI Guideline EP28-A3C, Defining, Establishing and Verifying Reference o Intervals in the Clinical Laboratory; Approved Guideline.

12. Performance Characteristics:

Method Comparison

A total of 155 samples spanning the assay range, were tested by the LIAISON® Vitamin B12 and by another commercially available method following CLSI EP09-A3, and yielded the following Passing & Bablok regression analysis:

LIAISON® Vitamin B12 = 0.97 (Reference Method) + 6.25; R = 0.985.

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| Assay | N | Slope (95% CI) | Intercept (95% CI) | Correlation
Coefficient |
|-------------|-----|------------------|--------------------|----------------------------|
| Vitamin B12 | 155 | 0.97 (0.94-1.00) | 6.25 (-3.50-18.29) | 0.985 |

Image /page/6/Figure/2 description: The image is a scatter plot titled "Scatter Plot with Passing & Bablok Fit". The x-axis is labeled "B12 (pg/mL) - Comparator Assay", ranging from 0 to 1500. The y-axis is labeled "LIAISON® 12 (pg/mL) - AVERAGE", ranging from 0 to 1600. The plot shows a linear relationship between the two variables, with a blue line representing the Passing & Bablok fit (6.25 + 0.97x) and a gray line representing identity.

Sample Matrix Comparison

Forty eight (48) matched patient sets of serum, SST serum and lithium heparin plasma samples were tested to determine if these sample types provide equivalent results on the LIAISON® Vitamin B12 assay.

Sample Equivalence SST serum compared to Serum

N = 48	Bias	95% CI
Constant	8.21	2.14 to 16.56
Proportional	0.97	0.94 to 0.99
R2	0.996	N/A

Sample Equivalence Lithium Heparin compared to Serum

N = 48	Bias	95% CI
Constant	14.78	1.09 to 29.87
Proportional	1.10	1.05 to 1.15
R2	0.988	N/A

Reference Range

It is recommended that each laboratory establish its own range of expected values for the population taken into consideration.

Observed Reference Ranges
Population (n=166)	Median	Observed Range
2.5th to 97.5th Percentile
United States	318.5 (pg/mL)	107.2 pg/mL – 653.3 pg/mL

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Prospectively collected serum samples from 166 apparently healthy adults aged 21-59 who had been fasting for at least 8 hours were obtained. Apparently healthy status of the adults were determined by the Inclusion/Exclusion criteria listed below. Samples were collected, centrifuged and removed from cells within 2 hours. Once serum was removed from the cells, the sample was frozen immediately and stored at -70°C in order to maintain integrity. Samples were shipped frozen and kept frozen until tested.

To assess the expected reference range for the LIAISON® Vitamin B12 assay, a study was performed with serum samples from 166 apparently healthy adults aged 21 - 59 years of age from mixed ethnic backgrounds (30% Caucasian, 31% African Americans, 39% Hispanics) who were fasting for at least 8 hrs. Apparently healthy status was determined by subjects who had no history of anemias, Folic acid or B12 deficiency, IBD or suspected IBD, celiac disease, gastrointestinal malabsorption disorders, or eating disorders. No oral contraceptive use within 3 months, and no alcohol within 48 hrs of blood draw or excessive alcohol usage. No pregnant women or anyone taking B12 supplementation were included in the study population.

Based on the 95% Confidence Interval, the following values were established following CLSI guideline C28-A3.

Precision

One (1) lot of kit controls and six (6) serum samples spanning the range of the assay measuring range were tested twice per day in duplicate, over 20 operating days using one (1) reagent lot at DiaSorin Inc. The testing was performed according to CLSI EP5-A3.

| | Mean | Intra-Run
Within One Lot
and Site | | Total Within
One Lot and
Site | |
|----------------|---------|-----------------------------------------|------|-------------------------------------|-------|
| Sample ID | (pg/mL) | SD | %CV | SD | %CV |
| Sample #1 (KC) | 642 | 21.56 | 3.4% | 42.99 | 6.7% |
| Sample #2 (KC) | 1262 | 48.79 | 3.9% | 86.28 | 6.8% |
| Sample #3 | 240 | 10.16 | 4.2% | 20.36 | 8.5% |
| Sample #4 | 417 | 21.85 | 5.2% | 39.76 | 9.5% |
| Sample #5 | 646 | 24.83 | 3.8% | 57.55 | 8.9% |
| Sample #6 | 773 | 29.36 | 3.8% | 60.12 | 7.8% |
| Sample #7 | 1039 | 39.87 | 3.8% | 103.87 | 10.0% |
| Sample #8 | 1093 | 47.96 | 4.4% | 93.89 | 8.6% |

Linearity

One (1) high sample of each specimen type (serum, lithium heparin plasma) containing endogenous and/or spiked Vitamin B12 above the measuring range of the assay at 1500 pg/mL was diluted and tested by the LIAISON® Vitamin B12 assav following CLSI EP6-A. The results for each sample were analyzed by regression of observed concentration versus expected concentration.

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The resulting equations for each sample type are: Serum: Observed Vitamin B12 = 1.076x + 6.896; R = 0.998 SST Serum: Observed Vitamin B12 = 1.009x + 0.224; R = 0.999 Lithium Heparin plasma: Observed Vitamin B12 = 1.029x - 0.095; R = 0.996

Recovery Study

Five (5) high concentration (endogenous or spiked) serum samples and five (5) low concentration serum samples were analyzed neat. Recovery samples were then prepared by mixing defined ratios of the high and low samples and tested in replicates of five (5). The mean results of the five (5) replicates are provided in the table below.

| | Defined
Concentration | Expected
(pg/mL) | Observed
(pg/mL) | %
Recovery |
|----------------| | Sample
High | 1484 | 2 H:1 L | | 1 H:1 L | | 1 H:2 L | | Low neat | 108 | Sample
High | 1280 | 2 H:1 L | | 1 H:1 L | | 1 H:2 L | | Low neat | 352 | Sample
High | 1112 | 2 H:1 L | | 1 H:1 L | | 1 H:2 L | | Low neat | 247 | Sample
High | 1098 | 2 H:1 L | | 1 H:1 L | | 1 H:2 L | | Low neat | 176 | Sample
High | 1184 | 2 H:1 L | | 1 H:1 L | | 1 H:2 L | | Low neat | 180 | | Recovery | 100% | --------------------------|---------------------|---------------------|---------------|
| - | - | - |
| 1129 | 1144 | 101% |
| 946 | 940 | 99% |
| 763 | 752 | 99% |
| - | - | - |
| - | - | - |
| 974 | 946 | 97% |
| 816 | 773 | 95% |
| 658 | 633 | 96% |
| - | - | - |
| - | - | - |
| 827 | 816 | 99% |
| 680 | 683 | 100% |
| 533 | 553 | 104% |
| - | - | - |
| - | - | - |
| 794 | 775 | 98% |
| 637 | 641 | 101% |
| 480 | 499 | 104% |
| - | - | - |
| - | - | - |
| 853 | 904 | 106% |
| 682 | 707 | 104% |
| 512 | 534 | 104% |
| - | - | - |
| | Mean

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Analytical Specificity

Cross-Reactivity Studies

Controlled Studies of potentially cross-reacting substances were performed on the LIAISON® Vitamin B12 assay at the concentrations listed below. The testing was based on CLSI-EP7-A2.

| Cross-Reactant | Spiked
Concentration | % Cross Reactivity |
|-------------------|-------------------------|--------------------|
| Dicyanocobinamide | 10,000 pg/mL | -0.19% |

The cross reactivity study for the LIAISON® Vitamin B12 was designed to evaluate potential interference from other closely analytes with similar structure.

Interference Studies

Controlled studies of potentially interfering substances performed in serum at two (2) levels (200 and 800 pq/mL) demonstrated no interference in the LIAISON® Vitamin B12 at the highest concentration for each substance listed below.

Drug/Substance	Concentration Tested
Hemoglobin	300 mg/dL
Bilirubin (conjugated)	40 mg/dL
Bilirubin (unconjugated)	40 mg/dL
Triglycerides	3,000 mg/dL
Cholesterol	500 mg/dL
Albumin	12 g/dL
Human IgG	12 g/dL
HAMA	1387.5 ng/mL
Rheumatoid Factor	1035 IU/mL
Acetaminophen	20 mg/dL
Acetylsalicylic Acid	65 mg/dL
Ibuprofen	50 mg/dL
Biotin	2 mg/mL

Limit of Blank, Limit of Detection and Limit of Quantitation

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline June 2012- Second Edition.

The following limits were determined with the LIAISON® Vitamin B12 assay: The limits are reported in the following table:

LoB	LoD	LoQ
≤ 38.7 pg/mL	51.2 pg/mL	55 pg/mL

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Stability

Product	Storage Conditions	Claimed stability
Reagent Integral	Open vial on system	42 days
Reagent Integral	Open vial 2-8°C	28 days
Calibration curve	N/A	21 days

Traceability

The LIAISON® Vitamin B12 Calibrators are traceable to an in-house standard preparation (pg/mL).

13. Conclusion:

The LIAISON® Vitamin B12 assay is substantially equivalent in principle and performance to the Beckman Coulter Access Vitamin B12 assay.