Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a manual assay test and does not require an automated system. There is no mention of AI, ML, or any computational analysis beyond reading absorbance values.

Therapeutic

No
This device is an in vitro diagnostic (IVD) assay used to quantitatively determine 25-hydroxyvitamin D levels, which assists clinicians in assessing vitamin D sufficiency. It is not used for treating or diagnosing a disease directly but provides information for diagnostic purposes.

Diagnostic

Yes

This device is a diagnostic device because its "Intended Use / Indications for Use" states that it provides a quantitative determination of 25-hydroxyvitamin D to "assist the clinician in the assessment of vitamin D sufficiency." This directly aims to diagnose or assess a health condition (vitamin D sufficiency).

SaMD (Software as a Medical Device)

No

The device is a manual assay test performed in a microtitre plate, requiring physical reagents and a microtitre plate reader, indicating it is a hardware-based in vitro diagnostic device, not software only.

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 25-hydroxyvitamin D... in human serum or plasma." This is a test performed in vitro (outside the body) on a biological sample.
Purpose: The results are used "to assist the clinician in the assessment of vitamin D sufficiency." This indicates the test provides information for medical diagnosis or assessment.
Device Description: The description details a laboratory assay performed on a microtitre plate using reagents to measure a substance in a biological sample. This is characteristic of an in vitro diagnostic test.
Performance Studies: The document includes performance studies like precision, linearity, detection limit, analytical specificity, and method comparison, which are standard for demonstrating the analytical performance of an IVD.
Predicate Device: The mention of a "predicate device" with a K number (K021163) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 25-Hydroxy Vitamin DS EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

Product codes (comma separated list FDA assigned to the subject device)

MRG

Device Description

The 25-Hydroxy Vitamin De EIA is a manual assay test and does not require the use of an automated system. The whole assay is performed in a microtitre plate and requires a user to perform each step.

The 25-Hydroxy Vitamin De assay is an enzymeimmunoassay for the quantitation of 25(OH)D and other hydroxylated metabolites in serum or plasma. 25uL of each calibrators, controls and samples are diluted with biotin labelled 25(OH)D. The diluted samples are incubated in microtitre wells which are coated with a highly specific sheep 25(OH)D at room temperature before aspiration and washing. Enzyme (horseradish peroxidase) labelled avidin, is added and binds selectively to complexed biotin and, following a further wash step, colour is developed using a chromogenic substrate (TMB).

The absorbance of the stopped reaction mixtures are read in a microtitre plate reader, colour intensity developed being inversely proportional to the concentration of 25(OH)D.

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

adult population

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)

1. Analytical performance:
a. Precision/Reproducibility:
Precision was determined in accordance with CLSI EP5-A2, "Evaluation of Precision Performance of Quantitative Measurement Methods". 10 serum samples were assayed using 3 lots of reagents in duplicate, twice per day for a minimum of 20 days (n ≥ 80 replicates per sample).

**b. Linearity/assay reportable range:**
Linearity was evaluated based on a modified version of CLSI EP-6A, "Evaluation of the Linearity of Quantitative Measurement Procedures". Samples containing varying concentrations of 25-hydroxyvitamin D were assayed in replicate of four. The resulting mean concentrations were compared to predicted concentrations. Samples were prepared by diluting a high patient sample with a low patient sample prior to assay. The linear regression (weighted) of the Observed concentrations versus the expected concentrations is:
Observed = 1.02 x (Expected) + 0.23 ng/mL
Observed = 1.02 x (Expected) + 0.58 nmol/L
Regression coefficient R == 1.00
Maximum deviation; -8.8% for samples > 20 ng/mL and 2.37 ng/ml for samples

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, line-art style, and the text is in a sans-serif font.

August 25, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

IMMUNODIAGNOSTIC SYSTEMS LTD. MICK HENDERSON RA OFFICER 10 DIDCOT WAY, BOLDON BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD, GREAT BRITAIN

Re: K142351

Trade/Device Name: 25-Hydroxy Vitamin De EIA Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG Dated: August 14, 2015 Received: August 19, 2015

Dear Mick Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142351

Device Name 25-Hydroxy Vitamin DS EIA

:

Indications for Use (Describe)

The 25-Hydroxy Vitamin DS EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 510k Number | 510(k) SUMMARY
K142351 | |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | determination of substantial equivalence. | According to the requirements of 21CFR807.92, the following
information provides sufficient detail to understand the basis for a |
| Submitter | Immunodiagnostic Systems Limited
10 Didcot Way
Boldon Business Park
Boldon
Tyne and Wear
NE35 9PD
United Kingdom | |
| | Contact Person: Mick Henderson
Phone: +44 191 5190660
Fax: +44 191 5190760
Email: mick.henderson@idsplc.com | |
| | Secondary Contact: Mr. R. Prebula
Hogan Lovells US LLP,
Columbia Square,
555 Thirteenth Street, NW,
Washington DC | |
| | 20004
Washington
Phone: (202)637 6548
Fax: (202)637 5910
Email: randy.prebula@hoganlovells.com | |
| | Date prepared:18 August 2015 | |
| Device Name | | |
| | Proprietary names: | 25-Hydroxy Vitamin Dª EIA |
| | Common names: | Vitamin D test |
| | Classification:
Regulatory Class: | 21CFR862.1825 Vitamin D Test System
II |
| | Product Code: | MRG |
| IDS, OCTEIA 25-OH Vitamin D EIA, (K021163)
Predicate Device Name: | | |

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A. Test Principle:

The 25-Hydroxy Vitamin De EIA is a manual assay test and does not require the use of an automated system. The whole assay is performed in a microtitre plate and requires a user to perform each step.

The 25-Hydroxy Vitamin De EIA assay

The 25-Hydroxy Vitamin De assay is an enzymeimmunoassay for the quantitation of 25(OH)D and other hydroxylated metabolites in serum or plasma. 25uL of each calibrators, controls and samples are diluted with biotin labelled 25(OH)D. The diluted samples are incubated in microtitre wells which are coated with a highly specific sheep 25(OH)D at room temperature before aspiration and washing. Enzyme (horseradish peroxidase) labelled avidin, is added and binds selectively to complexed biotin and, following a further wash step, colour is developed using a chromogenic substrate (TMB).

The absorbance of the stopped reaction mixtures are read in a microtitre plate reader, colour intensity developed being inversely proportional to the concentration of 25(OH)D.

B. Indications For Use:

For In Vitro Diagnostic Use

The 25-Hydroxy Vitamin De EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

Rx Only

C. Comparison with the predicate:

Similarities compared to the chosen predicate device (OCTEIA 25-hydroxy vitamin D EIA)

| | Predicate
K021163 | Candidate Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Intended Use | The OCTEIA 25-hydroxy
vitamin D EIA (25-OH D) kit is
an assay for the quantitative
measurement of 25-Hydroxy
vitamin D in serum and plasma. | Same |
| Indications for use | Results are to be used in
conjunction with other clinical
and laboratory data to assist the | Same |

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| | clinician in the assessment of
vitamin D sufficiency | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Analyte | 25-hydroxy vitamin D | Same |
| Reagent storage | 2-8°C | Same |
| Capture | Antibody coated micro plate | Same |
| Calibrator | Low charcoal stripped human
serum containing 25-hydroxy
vitamin D and sodium azide as a
preservative | Same |
| Sample volume | 25µL | Same |
| Units | nmol/L | Same |
| Kit components | EIA kit consisting of Anti-25-
OH D coated plate, Biotinylated
25-OH D, Standards (7 levels),
kit controls (2 levels), Avidin
HRP solution, substrate solution,
stop solution and wash solution | Same |
| Calibration | Full standard curve to be run
with all assays | Same |
| Calibration interval | Per assay run | Same |
| Quality Control | Two (2) controls provided | Same |
| Conversion of units | nmol/L x 0.40 = ng/mL
ng/ml. x 2.5 = nmol/L | Same |

Differences compared to the chosen (FDA cleared; marketed) predicate device

| | Predicate
K021163 | Candidate Device |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Antibodies | Sheep anti 25-hydroxy vitamin
D. | new source |
| Analytical sensitivity | 5 nmol/L | NA |
| Functional Sensitivity
(Limit of Quantitation
(LoQ) | NA | 4.8ng/mL (12 nmol/L) |
| Limit of Detection
(LoD) | NA | 2.7ng/mL (6.9 nmol/L) |
| Limit of Blank
(LoB) | NA | 1.3ng/mL (4.5nmol/L) |
| Precision | Intra-assay Precision n = 10
5.3% to 6.7% in the
concentration range 39 to
165nmol/L
Inter-assay Precision n = 11
4.6% to 8.7% in the
concentration range 40 to
132nmol/L | Within Run Precision n = 88
1.9% to 3.7% in the
concentration range 11.7 to
65.1 ng/mL (29.3 to 183
nmol/L)
Total Precision n = 88
3.7% to 11.6% in the
concentration range 11.7 to
65.1ng/mL (29.3 to 183
nmol/L) |

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Specificity,	Specificity	Specificity
Interfering substances	25-Hydroxy vitamin D3	25-Hydroxy vitamin D3
& Cross Reactivity	100%	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે

| Performance | Predicate
K021163 | Candidate Device |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specificity,
Interfering substances
& Cross Reactivity | Interference:
Haemoglobin
Tested up to 1470 mg/dL

Bilirubin
Tested up to 513 µmol/L

Lipid
Tested up to 5.6 mmol/L
triglyceride | Interference:
Haemoglobin
No interference up to
400mg/dL

Bilirubin, conjugated
No interference up to 20mg/dL

Triglyceride (Intra Lipid)
No interference up to
475mg/dL

Total Protein
No interference up to 9.2g/dL

HAMA
No interference up to
1000ng/mL

Red Blood Cells
No interference up to 0.4%

Rheumatoid Factor
No interference up to
800IU/mL

Vitamin D Binding Protein
(Gc globulin)
No interference up to 2000
ng/mL

Cholesterol, Total
No interference up to
500mg/dL