MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.

Device Description

MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (<0.1%) Calibrator Low-Containing BSA and 25-OH Vitamin D antigen, NaN3(<0.1%) Calibrator High- Containing BSA and 25-0H Vitamin D antigen, NaN3(<0.1%) Displacing Reagent- Acidic buffer ABEI Label- 25-OH Vitamin D antigen labeled with ABEI Control 1- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%) Control 2- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%)

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance & Compliance
Precision	CV% within acceptable limits for various levels (Controls, Calibrators, Serum Pools) across repeatability, within-run, between-day, and total reproducibility.	All reported CV% values are within typical acceptable ranges for clinical assays, indicating good precision. Example: Control 1 Total CV of 6.33% and Reproducibility CV of 6.46%.
Linearity	Demonstrate linearity across the claimed measuring range with a strong correlation coefficient (R²).	Linear between 4.6 and 145.8 ng/mL with R² = 0.9986. (Meets)
Stability	Reagents, calibrators, and controls maintain stability over a reasonable period (e.g., 12 months at 2-8°C).	Accelerated studies show stability for 12 months at 2-8°C for controls, calibrators, and reagents. Real-time stability is ongoing. (Meets based on accelerated data)
Detection Limit (LOB)	Limit of blank should be low, indicating the ability to differentiate from zero.	LOB = 1.990 ng/mL. (Meets)
Detection Limit (LOD)	Limit of detection should be low, indicating the lowest concentration at which analyte can be detected.	LOD = 3.8 ng/mL. (Meets)
Limit of Quantitation (LOQ)	LOQ should be the lowest concentration reproducibly measurable with an intermediate precision CV of ≤ 20%.	LOQ = 5.371 ng/mL with an intermediate precision CV of ≤ 20%. (Meets)
Interference (Cross-reactivity)	Minimal cross-reactivity with structurally similar compounds.	High cross-reactivity with 25-OH Vitamin D2 (98.10%) and D3 (96.13%), which is expected as the assay measures total 25-OH Vitamin D. Low cross-reactivity with other D metabolites (e.g., Vitamin D2, Vitamin D3, 1,25-(OH)2-Vitamin D3). (Meets, as intended for total 25-OH Vitamin D)
Interference (Endogenous Substances)	No significant interference from common endogenous substances (bilirubin, hemoglobin, triglycerides, etc.) at high concentrations.	No significant interference observed (defined as recovery ± 10% of initial value) at high concentrations listed for each substance. (Meets)
Interference (Common Drugs/Substances)	No significant interference from common drugs and other substances (e.g., Ascorbic Acid, Acetaminophen, Biotin) at typical therapeutic/high concentrations.	No significant interference observed (defined as recovery ± 10% of initial value) at high concentrations listed for each substance. (Meets)
Interference (HAMA, RF, Total Protein)	No significant interference from HAMA, RF, and total protein at high concentrations.	No significant interference observed (defined as recovery ± 10% of initial value) at high concentrations listed for each substance. (Meets)
Method Comparison	Strong correlation and agreement with a legally marketed predicate device.	Regression equation: Y = 1.013X - 0.504, R² = 0.9739, indicating strong correlation and agreement with the predicate. (Meets)

Study Details:

The provided document describes a series of analytical performance studies and a method comparison study to demonstrate the performance characteristics of the MAGLUMI 2000 25-OH Vitamin D assay.

2. Sample Sizes and Data Provenance

Test Set (for specific performance characteristics):
- Precision: 240 samples per level across 9 sample types (3 controls, 2 calibrators, 3 spiked serum pools, 3 native serum pools). Total N = 240 * 9 = 2160 individual measurements (though some are duplicates/runs, the total 'data points' are numerous).
- Linearity: 11 levels of linearity samples, each measured in quadruplicate, on 3 lots of reagent.
- Detection Limit:
  - LOB: 60 measurements of 25-OH VITAMIN D depleted serum samples using 3 different lots of reagents over 5 days.
  - LOD: 4 levels of low samples measured in 60 replicates over 5 days per sample using 3 lots of reagents.
  - LOQ: Six low serum samples, in six replicates per run, one run per day, over 5 days, using 3 lots of reagents.
- Interference (Cross-reactivity): Used two base serum samples (30 ng/mL and 60 ng/mL total 25-OH VD) spiked with various cross-reactants, measured using 3 lots of reagents.
- Interference (Endogenous Substances & Common Drugs): Three serum samples (20, 30, and 60 ng/mL 25-OH VITAMIN D) analyzed for each substance.
- Interference (HAMA, RF, Total Protein): Human serum samples supplemented with potential interferents, tested using 3 lots of reagents.
- Method Comparison: 241 human serum samples.
Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It uses "human serum samples" and "patient serum pools." The studies appear to be retrospective in nature, using collected serum samples.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic immunoassay. The concept of "ground truth" established by experts (like radiologists for imaging) is not applicable in the same way. The ground truth for such assays is typically established by:
- Known concentrations for controls and calibrators, often traceable to reference materials (e.g., NIST RMP 2972 for traceability as mentioned).
- Spiking studies where a known amount of analyte is added to a sample.
- Comparison to a legally marketed predicate device, which itself has an established ground truth.
- Pathology/biochemical analysis where the exact concentration of the analyte is determined by highly accurate reference methods (e.g., ID-LC-MS/MS).
Therefore, there were no human experts establishing the ground truth in the context of clinical interpretation, but rather a robust analytical process to define true concentrations.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings where human interpretation or consensus for a diagnosis is required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices (often imaging AI) where multiple human readers interpret cases and their performance is compared with and without AI assistance. The MAGLUMI 2000 25-OH Vitamin D is an automated immunoassay, not a device requiring human interpretation in this manner.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance was done. The entire analytical performance section (Precision, Linearity, Stability, Detection Limit, Interference) directly assesses the algorithm's (the immunoassay's) performance without human intervention in the measurement process. The "MAGLUMI 2000 Fully-auto chemiluminescence immunoassay analyzer" is an automated system, meaning the results are generated directly by the device. The method comparison study is also a standalone assessment of the device's output against a predicate.

7. Type of Ground Truth Used

The ground truth for the analytical validation aspects (e.g., calibrators, controls, linearity samples) is based on pre-defined concentrations, often traceable to reference methods like ID-LC-MS/MS (Isotope Dilution Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) and reference materials such as NIST RMP 2972.
For interference studies, the "ground truth" is inferred by the known addition of interferents and measuring the deviation from the expected value.

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. This device is an immunoassay, which functions based on established biochemical principles and reagents, not on a machine learning model that requires a separate training set. The "development" or "optimization" of the assay would involve various experiments, but not a formally defined "training set" like in AI/ML validation.

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

Not applicable, as there is no mention of a training set for an AI/ML model for this immunoassay.

Summary

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August 1, 2019

Shenzhen New Industries Biomedical Engineering Co., Ltd % Joe Shia. Director LSI International Inc 504E Diamond Ave., Suite F Gaithersburg, MD 20877

Re: K191499

Trade/Device Name: MAGLUMI 2000 25-OH Vitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: June 2, 2019 Received: June 6, 2019

Dear Joe Shia:

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

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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 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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191499

Device Name MAGLUMI 2000 25-OH Vitamin D

Indications for Use (Describe)

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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K191499

510(k) SUMMARY

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

1. Date: July 26, 2019
1. Submitter: Shenzhen New Industries Biomedical Engineering Co., Ltd. No.16, Jinhui Road, Pingshan New District, Shenzhen China 518122
1. Contact person: Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl(@yahoo.com
1. Device Name: MAGLUMI 2000 25-OH VITAMIN D

Classification: Class II (assay)

Product Code	CFR #	Product Name
MRG	862.1825	Vitamin D Test System

1. Predicate Devices:
  K 112725, DiaSorin LIAISON 25-OH VITAMIN D Total Assay
1. Device Description:
  MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (<0.1%) Calibrator Low-Containing BSA and 25-OH Vitamin D antigen, NaN3(<0.1%) Calibrator High- Containing BSA and 25-0H Vitamin D antigen, NaN3(<0.1%) Displacing Reagent- Acidic buffer ABEI Label- 25-OH Vitamin D antigen labeled with ABEI Control 1- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%) Control 2- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%)
1. Intended Use:
  MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the

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quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.

1. Standard/Guidance Documents
  Clinical and Laboratory Standards Institute EP5-A2 - Evaluation of Precision Performance of Clinical Chemistry Devices-Approved Guideline-Second Edition.

Clinical and Laboratory Standards Institute EP6-A - Evaluation of the Linearity of Quantitative Analytical

Clinical and Laboratory Standards Institute EP17-A2: Evaluation of detection Capability for Clinical Laboratory Measurement Procedures

Clinical and Laboratory Standards Institute EP7-A2 - Interference Testing in Clinical Chemistry Clinical and Laboratory Standards Institute EP9-A2 - Method Comparison and Bias Estimation Using Patient Samples

1. Substantial Equivalence Information

Item	Predicate Device	Candidate Device
Intended Use/Indication forUse	For the quantitative determination of 25-hydroxyvitamin D and other hydroxylatedvitamin D metabolites to be used in theassessment of vitamin D sufficiency usingthe LIAISON® Analyzer family.	Same
Specimen	Serum (plain serum tubes and serumseparator tubes)	Same
Measurement	Quantitative	Same
Calibration	2 points	Same
Calibrator	Calibrator 1 and Calibrator 2	Calibrator Low and Calibrator High
Automated	Yes	Same

Assay Similarities

Assay Differences

Item	Predicate Device	Candidate Device
Test principle	Direct competitive chemiluminescenceimmunoassay (CLIA)	Two-step Competitivechemiluminescence immunoassay(CLIA)
Traceability	Calibrators are traceable to concentrationsdetermined by UV	ID-LC-MS/MS traceable toNIST RMP 2972

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	spectrophotometric analysis
Measuring range	4-150 ng/ml	5.371-143 ng/ml
Capture antibody	Magnetic particles coated with antibody against 25 OH Vitamin D	Magnetic microbeads coated with 25-OH Vitamin D monoclonal antibody
Detection	25 OH Vitamin D conjugated to an isoluminol derivative	ABEI-labeled 25-OH Vitamin D antigen
Sample size	25 ul	100 ul

10. Test Principle

The 25-OH VITAMIN D assay is a competitive chemiluminescence immunoassay using FDA previously cleared MAGLUMI 2000 instrument (K162698).

The 25-OH Vitamin D assay is a two-incubation chemiluminescence immunoassay for the quantitative determination of total 25-OH vitamin D in human serum. In the first incubation, the 25-OH vitamin D is dissociated from its binding protein by the displacing reagent and binds to the 25-0H vitamin D antibody on the magnetic microbeads forming an antibodyantigen complex. Following a second incubation, the 25-OH Vitamin D labeled ABEI are added. The rest unbound material is removed during a wash cycle. Subsequently, the Starter 1+2 are added to initiate a flash chemiluminescent reaction. The resulting chemiluminescent reaction is measured as relative light units (RLUs), which is inversely proportional to the concentration of 25-OH Vitamin D present in the sample (or calibrator/control, if applicable).

11. Performance Characteristics

1. Analytical Performance
- a. Precision

The precision was determined using the CLSI EP5-A3 protocol as a guide. The study was conducted on three different instruments with three controls, two calibrators, three spiked patient serum pools and three native patient sample pools. The data was collected over 20 days in duplicate with 2 runs per day with a total of 80 samples analyzed per level on each instrument. The results (in ng/mL) obtained are summarized in the following tables:

Sample	N	Mean(ng/mL)	Repeatability		Between-Run		Between-Day		Total(within instrument)		Reproducibility(across instruments)
			SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Control 1	240	30.077	1.039	3.45	0.389	1.29	1.546	5.14	1.903	6.33	1.944	6.46
Control 2	240	60.362	1.625	2.69	0.487	0.81	2.590	4.29	3.096	5.13	3.096	5.13
Control 3	240	119.953	1.741	1.45	1.842	1.54	3.971	3.31	4.711	3.93	4.930	4.11
CalibratorLow	240	7.635	0.385	5.04	0.177	2.32	0.408	5.34	0.588	7.70	0.602	7.89
CalibratorHigh	240	97.863	1.529	1.56	0.938	0.96	3.585	3.66	4.009	4.10	4.278	4.37

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Spiked SerumPool 1	240	56.361	1.850	3.28	0.576	1.02	1.788	3.17	2.637	4.68	2.764	4.90
Spiked SerumPool 2	240	80.795	1.800	2.23	0.705	0.87	1.972	2.44	2.762	3.42	2.812	3.48
Spiked SerumPool 3	240	130.363	1.530	1.17	1.960	1.50	3.572	2.74	4.353	3.34	4.701	3.61
Native SerumPool 1	240	8.387	0.458	5.46	0.235	2.80	0.578	6.89	0.774	9.23	0.778	9.28
Native SerumPool 2	240	30.512	1.092	3.58	0.682	2.24	1.330	4.36	1.851	6.07	2.220	7.27
Native SerumPool 3	240	106.049	1.353	1.28	1.971	1.86	2.068	1.95	3.161	2.98	3.313	3.12

b. Linearity

The linearity of the MAGLUMI 25-OH VITAMIN D method was determined following the CLSI EP6-A procedure. Eleven levels of linearity samples were prepared by blending a low serum sample pool and a high serum sample pool to span the whole measuring range with 25-OH VITAMIN D concentrations from 4.6 to 145.8 ng/mL. Each sample was measured in quadruple on 3 lots of reagent. Linearity was evaluated using regression analysis based on CLSI EP6-A.

The assays are linear between 4.6 and 145.8 ng/mL with the following relationship: Observed = 0.9885 (Expected) + 0.1192, R2 = 0.9986

c. Stability
Accelerated stability study at 37°C showed that all controls are stable for 12 months at 2-8°C. Accelerated stability study at 37°C showed all that calibrators are stable for 12 months at 2-8°C. Accelerated stability study at 37°C showed that the reagent is stable for 12 months at 2-8°C. The real time stability at 2-8°C is on-going.
d. Detection Limit
Detection limit studies were performed following CLSI EP17-A guidelines. The limit of blank (LOB) is the 95th percentile value from 60 measurements of 25-OH VITAMIN D depleted serum samples using 3 different lots of 25-OH VITAMIN D reagents over 5 days. The LOB corresponds to the concentration below which analyte-free samples are found with a probability of 95% and was determined to be 1.990 ng/mL (highest of the 3 lots). The limit of detection (LOD) is determined based on the LOB and the standard

deviation of low concentration samples. The LOD corresponds to the lowest analyte concentration which can be detected. Four level of low samples were measured in 60 replicates over 5 days per sample using 3 lots of reagents. LOD was determined to be 3.8 ng/mL (highest of the 3 lots).

The limit of quantitation (LOQ) was determined by measuring six low serum samples, in six replicates per run, one run per day, over 5 days, using 3 lots of reagents. LOQ is defined as the lowest analyte concentration that can be

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reproducibly measured with an intermediate precision CV of ≤ 20 % and was determined to be 5.371 ng/mL (highest of the 3 lots).

Interference e.
A cross reactivity study was performed using two base serum samples containing total 25-OH VD 30 ng/mL and 60 ng/mL respectively. These samples were spiked with various cross reactants and measured for these solutions using 3 lots of reagents. The following table shows cross reactivity of potential cross reactant.

Cross Reactant	%Cross-reactivity
25-OH Vitamin D2	98.10%
25-OH Vitamin D3	96.13%
Vitamin D2	1.04%
Vitamin D3	1.98%
1,25-(OH)2-Vitamin D3	8.12%
1,25-(OH)2-Vitamin D2	8.77%
3-epi-25OH D3	2.04%

The effect of endogeous substances were evaluated using human serum pools. For each substance, three serum samples containing 20, 30 and 60ng/mL concentration of 25-OH VITAMIN D were analyzed, the highest concentration of interferents were listed below at which no significant interference was observed.

Potential Interferent	Highest concentration tested at which nosignificant interference is observed (mg/dL)
Conjugated bilirubin	60
Unconjugated bilirubin	42.5
Hemoglobin	250
triglyceride	500
Uric acid	20
Cholesterol	300

The effect of common drugs and interference substances were evaluated using human serum pools. For each substance, three serum samples containing 20, 30 and 60ng/mL concentration of 25-OH VITAMIN D were analyzed. For all substances tested, no significant interference was defined as recovery ± 10% of initial value. The substances and the highest concentration tested which did not cause significant interference are listed below.

Potential Interferent	Highest concentration tested at which nosignificant interference is observed (mg/dL)
Cefoxitin	340
Levodopa	3.25
Metronidazole	12.3
Ascorbic Acid (Vitamin C)	16.95
Acetaminophen	15.6

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Biotin	5
Cyclosporine	0.6
Rifampicin	6.5
Doxycycline	3.2
Theophylline	11.4

The effect of human anti-mouse antibodies (HAMA), rheumatoid factor (RF) and human serum total protein was evaluated using human serum samples. Each potential interferent was added to 25-OH VITAMIN D human serum samples and tested using 3 lots of reagents. For all substances tested, no significant interference was defined as recovery ± 10% of initial value. The potential interferents and the highest concentration tested which did not cause significant interference are listed below.

Potential Interferent	Highest concentration tested at which no significant interference is observed (mg/dL)
HAMA	401 ng/mL
RF	1745 IU/mL
Total protein	6.25 g/dL

2. Comparison Studies

A method comparison study was performed with 241 human serum samples with concentrations ranging from 5.371 to 143 ng/mL. The comparison of the MAGLUMI 25-OH VITAMIN D assay (y) with the predicate device, LIAISON 25-OH VITAMIN D total assay (x), produced the following

linear regression equation:

Y = 1.013X - 0.504, R2 =0.9739

1. Expected values/Reference range:
  A total of 302 serum samples from normal, apparently healthy adult (20 years and older) individuals were tested according to the procedure in CLSI C28-A3. The expected normal range is 9.99 - 49.3 ng/dL based on the central 95% of the frequency distribution.

12. Conclusion

Based on the test principle and acceptable performance characteristics including precision. interference, specificity and method comparison of the device, it is concluded that the MAGLUMI 2000 25-OH VITAMIN D is substantially equivalent to the predicate.

Regulation Number and Section

§ 862.1825 Vitamin D test system.

(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.