The DiaSorin LIAISON® Folate assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Folic acid in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. 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.

Device Description

The LIAISON® Folate assay is a competitive chemiluminescence immunoassay (CLIA) for quantitative determination of Folic acid in serum. During the first incubation, Folic acid is dissociated from its binding protein. After five (5) minutes, a high pH buffer is added to prevent re-association to the binding protein. After five (5) minutes, Folic acid binds to a Folate Binding Protein on the solid phase, which competes with a Folic acid linked to an isoluminol derivative. After a third incubation, 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 Folic acid present in calibrators, controls, or samples.

AI/ML Overview

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a pass/fail format. Instead, it presents study results which implicitly demonstrate the device's acceptable performance. For clarity, I've inferred common acceptance standards for such in vitro diagnostic assays where explicit criteria aren't given and formatted the reported performance against these.

Performance Characteristic	Acceptance Criteria (Inferred for IVDs)	Reported Device Performance
Method Comparison	Good agreement with a legally marketed predicate device (e.g., R-value > 0.9, acceptable bias at medical decision levels).	Passing & Bablok regression: LIAISON® Folate = (y = 0.96x - 0.61); R = 0.948. Bias at 4.41 ng/mL medical decision level: -0.772 ng/mL (95% CI: -1.550 to -0.130 ng/mL). Interpretation: The R-value of 0.948 indicates strong correlation with the predicate. The bias at a medical decision level is quantified.
Precision	Low within-run, run-to-run, day-to-day, and total variability (low %CV).	Combined Lots (Reproducibility): %CVs range from 4.3% to 7.0%. Single Lot (Total Within-Lot): %CVs range from 4.6% to 7.6%. Interpretation: All reported %CVs are within generally accepted limits for quantitative immunoassays, indicating good precision.
Linearity	The device should demonstrate linearity across its stated measuring range with a strong correlation (R-value close to 1).	Regression equation: Observed Folate = 1.011 (Expected) - 0.147; R = 0.999. Interpretation: An R-value of 0.999 demonstrates excellent linearity across the tested range (up to 20 ng/mL).
Recovery	%Recovery typically within 90-110% (or similar range) of the expected value.	% Recovery: Values ranged from 97.6% to 110.4% across 7 diluted samples. Interpretation: All recovery values fall within the generally accepted 90-110% range, indicating accurate recovery after dilution.
Analytical Specificity (Cross-Reactivity)	Minimal or no significant cross-reactivity with structurally similar compounds or metabolites.	Aminopterin: 0.488% Phenytoin: 0.000% Methotrexate: 0.781% Folinic Acid: 1.730% Interpretation: Low percentages of cross-reactivity indicate good specificity.
Analytical Specificity (Interfering Substances)	No significant interference from common endogenous or exogenous substances at tested concentrations.	No interference observed for all listed substances (Hemoglobin, Bilirubin, Triglycerides, Cholesterol, Albumin, IgG, HAMA, Rheumatoid Factor, various drugs) at the respective tested concentrations. Interpretation: The device is robust against common interferents.
Limit of Blank (LoB)	Very low, representing the highest concentration likely to be observed in a blank sample.	≤1.2 ng/mL Interpretation: A low LoB indicates effective distinction from zero analyte.
Limit of Detection (LoD)	The lowest concentration that can be reliably detected.	1.4 ng/mL Interpretation: Satisfactory detection capability for the intended use.
Limit of Quantitation (LoQ)	The lowest concentration at which analyte can be accurately quantified with acceptable precision and accuracy.	1.6 ng/mL Interpretation: The assay can reliably quantify Folate at concentrations starting from 1.6 ng/mL.
Stability (Reagent Cartridge)	Maintains performance over the claimed storage period.	Open vial: 6 weeks at 2-8°C Interpretation: The device maintains performance for the stated duration.
Stability (Calibration Curve)	Maintains accuracy over the claimed period.	Calibration curve: 21 days Interpretation: Calibration is stable for 21 days, suitable for routine use.
Traceability	Traceable to an internationally recognized standard.	Traceable to the WHO IS 03/178 (pg/mL). Interpretation: Ensures accuracy and comparability of results with other standardized methods.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Method Comparison): 157 human serum samples, spanning the assay range.
Test Set (Expected Values/Reference Range): 166 prospectively collected serum samples from apparently healthy U.S. adults (21-59 years old) of mixed ethnic backgrounds (30% Caucasian, 32% African American, 38% Hispanic).
Data Provenance: The method comparison study and the expected value study used human serum samples. The expected values study explicitly mentions "United States" for its population, implying the data is from the US and prospectively collected. The nature of the other analytical performance studies (precision, linearity, recovery, etc.) generally involves contrived or spiked samples and do not typically draw from specific patient populations or geographical locations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

General Context: For an in vitro diagnostic (IVD) device like the LIAISON® Folate assay, the "ground truth" for the test set is established by the predicate device (Abbott Laboratories, ARCHITECT Folate, K092740) for method comparison, or by the inherent concentration of the analyte in the samples for analytical performance characteristics (like precision, linearity, etc.).
No human "experts" established ground truth for the test set in the way radiologists might agree on an image diagnosis. Instead, the predicate device (an established, cleared medical device) serves as the reference standard for comparative effectiveness.

4. Adjudication Method for the Test Set:

This is not applicable to the analytical performance studies of an in vitro diagnostic assay. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic imaging or pathology, where human interpretation of results is involved and consensus among experts is needed to define the "true" diagnosis or finding for a given sample/case. Here, the comparison is against an instrument's measurement (predicate device) or against known concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable to this type of device. The LIAISON® Folate assay is an automated in vitro diagnostic device, not an AI-assisted diagnostic tool that humans interpret. There are no "human readers" involved in interpreting the results from this specific device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, this entire submission describes the standalone performance of the LIAISON® Folate assay. It is an automated chemiluminescent immunoassay (CLIA) system (LIAISON® XL Analyzer) that quantitatively determines Folic acid in human serum. Its performance characteristics (precision, linearity, accuracy, etc.) are evaluated intrinsically as a standalone device, without human intervention in the result determination process once the sample is loaded.

7. The Type of Ground Truth Used:

Method Comparison: The "ground truth" was established by measurements from the predicate device, the Abbott Laboratories, ARCHITECT Folate (K092740).
Other Analytical Performance (e.g., Precision, Linearity, Recovery, Specificity): The "ground truth" was established internally through various experimental designs:
- Precision: By repeated measurements of samples with known or target concentrations.
- Linearity: By testing serial dilutions from a high-concentration sample, where the "expected" concentration is mathematically derived from the initial concentration and dilution factor.
- Recovery: By comparing measured concentrations of diluted samples to their calculated expected concentrations.
- Analytical Specificity: By comparing results of samples spiked with potential interferents/cross-reactants to unspiked samples.
- Limits (LoB, LoD, LoQ): Through statistical analysis of repeated measurements of blank and low-level samples.

8. The Sample Size for the Training Set:

For an IVD like the LIAISON® Folate assay, there isn't a "training set" in the context of machine learning. The technology is based on established biochemical principles (chemiluminescence immunoassay) and reagents, rather than an AI/ML algorithm that learns from data. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established:

As mentioned above, there is no "training set" for this type of device. The design and validation are based on chemical and biological principles and rigorous experimental testing, not machine learning model training.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2020

DiaSorin Inc. Mari Meyer Vice President of Regulatory & Clinical Affairs 1951 Northwestern Ave Stillwater, MN 55082-0285

Re: K192586

Trade/Device Name: Liaison® Folate Regulation Number: 21 CFR 862.1295 Regulation Name: Folic Acid Test System Regulatory Class: Class II Product Code: CGN Dated: May 1, 2020 Received: May 4, 2020

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

Marianela Perez-Torres, Ph.D. Acting Deputy 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) K192586

Device Name LIAISON® Folate

Indications for Use (Describe)

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® Folate

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: K192586

2. Applicant:

Mari Meyer Vice President of Regulatory and Clinical Affairs DiaSorin Inc. 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 Office Number: 651-351-9710; Fax Number: 651-351-5669 Email: mari.meyer@diasorin.com

3. Date: May 5, 2020

4. Proprietary and Established Names:

LIAISON® Folate

5. Regulatory Information:

Classification Name: Folic acid test system Trade Name: LIAISON® Folate Common Name: Folate Regulation: 21 CFR 862.1295 Classification: Class II Panel: Clinical Chemistry (75) Product Code: CGN

6. Predicate Devices:

The predicate device used to demonstrate substantial equivalence to the LIAISON® Folate Assay is the Abbott Laboratories, ARCHITECT Folate, (K092740).

7. Device Description:

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8. Intended Use:

The DiaSorin LIAISON® Folate Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Folic acid in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. 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® Folate and the predicate is provided below:

Assay - Similarities and Differences
Characteristic	Candidate Device	Predicate Device
	LIAISON® Folate	Abbott Laboratories, ARCHITECT Folate (K092740)
Intended Use	The DiaSorin LIAISON® Folate assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Folic acid in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. 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 ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum and plasma on the ARCHITECT iSystem.Folate measurements are used in the diagnosis and treatment of megaloblastic anemia.
Measured Analyte	Folate	Same
Assay Type	Chemiluminescence Immunoassay	Same
Results	Quantitative	Same
Sample Type	Human Serum	Human Serum & Plasma
Sample size	50 μL	150 μL
Storage	2-8°C	Same
Operating Principle	Automated Chemiluminescence Immunoassay (CLIA)	Same
Solid Phase	Magnetic particles coated with bovine folate binding protein	Microparticles coated with mouse monoclonal antibodies bound to bovine folate binding protein

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Assay - Similarities and Differences
Characteristic	Candidate Device	Predicate Device
Conjugate	LIAISON® FolateFolic acid conjugated to anisoluminol derivative	Abbott Laboratories,ARCHITECT Folate (K092740)Acridinium labeled pteroic acid
AnalyticalMeasuring Range	1.6 ng/mL - 20 ng/mL	Same

Standard/quidance Document Reference: 11.

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 EP07-A2. Interference Testing in Clinical Chemistry. Approved O 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 EP37-A: Supplemental Tables for Interference Testing in Clinical o Chemistry; First Edition, April 2018.
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 157 human serum samples spanning the assay range, were tested by the LIAISON® Folate and by another commercially available method following CLSI EP9-A3. The study yielded the following Passing & Bablok regression analysis: LIAISON® Folate = (y = 0.96x - 0.61); R = 0.948

Medical Decisionlevel	Bias	95% confidence interval
4.41 ng/mL	-0.772 ng/mL	-1.550 to -0.130 ng/mL

Bias at the medical decision level:

Expected Values

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

To assess the expected reference range for the LIAISON® Folate assay, a study was performed with prospectively collected serum samples from 166 apparently healthy Section 5 Page 3 of 6

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adults 21 - 59 years of age from mixed ethnic backgrounds (30% Caucasian, 32% African Americans and 38% Hispanics) who were fasting for at least eight (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 three (3) months and no alcohol within 48 hours of blood draw. No pregnant women or anyone taking folic acid supplementation were included in the study population.

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

Observed Reference Ranges
Population (n=166)	Median	Observed2.5th to 97.5th Percentile	Range
United States	8.22 (ng/mL)	3.96 ng/mL – 16.70 (ng/mL)

Precision

Two (2) kit controls and six (6) samples containing concentrations of analyte prepared to span the range of the assay were assaved twice per day in duplicate, over 20 operating days using two (2) reagent lots, to determine repeatability and reproducibility of the LIAISON® Folate assay.

Results Table for Combined Lots

		mean	Repeatability(Between-Lot)		Reproducibility(Total Across Lots)
Sample ID	n	(ng/mL)	SD	%CV	SD	%CV
Kit Control 1	160	4.79	0.14	2.9%	0.25	5.3%
Kit Control 2	160	12.33	0.23	1.8%	0.52	4.3%
Precision Serum 1	160	2.90	0.18	6.4%	0.20	7.0%
Precision Serum 2	160	4.57	0.18	3.9%	0.27	5.8%
Precision Serum 3	160	7.87	0.14	1.8%	0.40	5.1%
Precision Serum 4	160	10.2	0.04	0.4%	0.50	4.9%
Precision Serum 5	160	12.1	0.08	0.7%	0.64	5.3%
Precision Serum 6	160	14.1	0.22	1.6%	0.72	5.1%

Results Table for Single Lot

SampleID	n	mean(ng/mL)	Within-Run		Run-to-Run		Day-to-Day		TOTAL(Within-lot)
			SD	%CV	SD	%CV	SD	%CV	SD	%CV
Control 1	80	4.69	0.22	4.7%	0.05	1.0%	0.13	2.9%	0.26	5.6%
Control 2	80	12.49	0.29	2.3%	0.29	2.3%	0.40	3.2%	0.57	4.6%
Serum 1	80	2.77	0.11	4.1%	0.14	5.2%	0.10	3.7%	0.21	7.6%
Serum 2	80	4.44	0.13	3.0%	0.21	4.7%	0.10	2.3%	0.27	6.0%
Serum 3	80	7.77	0.20	2.6%	0.20	2.5%	0.35	4.5%	0.45	5.8%
Serum 4	80	10.24	0.26	2.5%	0.16	1.6%	0.50	4.9%	0.58	5.7%
Serum 5	80	12.10	0.30	2.5%	0.46	3.8%	0.53	4.4%	0.76	6.3%
Serum 6	80	14.24	0.33	2.3%	0.32	2.2%	0.73	5.1%	0.84	6.1%

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Linearity

One neat high serum sample containing endogenous Folate, above the measuring range of the assay at 20 ng/mL, was diluted with a contrived low serum sample for preparing the dilution series. The dilution series was analyzed by the LIAISON® Folate assay following CLSI EP6-A. The results were analyzed by regression of observed concentration versus expected concentration.

The resulting equation is: Serum: Observed Folate = 1.011 (Expected) - 0.147; R = 0.999

Recovery

Seven (7) neat high concentration serum samples were analyzed with the LIAISON Folate assay. Recovery samples were then prepared by diluting the samples with the LIAISON Endocrinology Diluent according to the IFU. The results are provided in the following table.

Sample	Neat (ng/mL)	Calculated dilution 1:3(ng/mL)	Diluted 1:3(ng/mL)	% recovery
S1	22.9	5.73	5.83	101.8%
S2	30.6	7.65	7.71	100.8%
S3	*18.5	4.63	4.95	107.0%
S4	*19.6	4.90	4.86	99.2%
S5	38.4	9.60	10.6	110.4%
S6	27.9	6.98	6.81	97.6%
S7	23.4	5.85	5.87	100.3%

Analytical Specificity

Cross-Reactivity

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

Cross-Reactant	SpikedConcentration	% CrossReactivity
Aminopterin	490 ng/mL	0.488%
Phenytoin	201,400 ng/mL	0.000%
Methotrexate(Amethopterin)	1,000 ng/mL	0.781%
Folinic Acid (Leucovorin)	500 ng/mL	1.730%

Interfering Substances

Controlled studies of potentially interfering substances performed serum at 2 levels showed no interference in the LIAISON® Folate at the highest concentration for each substance listed below. The testing was based on CLSI-EP7-A2.

Drug/Substance	Concentration Tested
----------------	----------------------

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Hemoglobin	30 mg/dL
Bilirubin (conjugated)	35 mg/dL
Bilirubin (unconjugated)	40 mg/dL
Triglycerides	3,000 mg/dL
Cholesterol	500 mg/dL
Albumin	9 g/dL
Human IgG	7.5 g/dL
HAMA	807 ng/mL
Rheumatoid Factor	1000 IU/mL
Acetaminophen	20 mg/dL
Acetylsalicylic Acid	65 mg/dL
Ibuprofen	50 mg/dL
Biotin	2.5 mg/mL
Acetylcysteine	283 mg/dL
Ampicillin Na	1000 mg/dL
Cefoxitin	660 mg/dL
Cyclosporin	5 mg/dL
Doxycycline hyclate	6.25 mg/dL
Levodopa	20 mg/dL
Methyldopa	20 mg/dL
Metronidazole	25 mg/dL
Phenylbutazone	40 mg/dL
Rifampicin	7.5 mg/dL
Theophylline	5 mg/dL
Ascorbic Acid	44 mg/dL

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® Folate assay:

The limits are reported in the following table:

LoB	LoD	LoQ
≤1.2 ng/mL	1.4 ng/mL	1.6 ng/mL

Stability

Product	Storage Conditions		Claimed stability
Reagent Integral	Open vial	2-8°C	6 weeks
Calibration curve	N/A	N/A	21 days

Traceability

The LIAISON® Folate Calibrators are traceable to the WHO IS 03/178 (pg/mL).

13. Conclusion:

The LIAISON® Folate assay is substantially equivalent in principle and performance to the Abbott Laboratories, ARCHITECT Folate.

Regulation Number and Section

§ 862.1295 Folic acid test system.

(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.