(290 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay using chemical reagents and an automated system for quantitative determination. There is no mention of AI, ML, image processing, or any data analysis techniques that would suggest the use of such technologies. The performance studies focus on analytical and method comparison metrics typical of IVD assays.
No
This device is an in vitro diagnostic (IVD) assay used for the quantitative determination of 25-hydroxyvitamin D in human serum to assist in the assessment of vitamin D sufficiency, not for treating a condition.
Yes
The device "assists the clinician in the assessment of vitamin D sufficiency," which is a diagnostic purpose.
No
The device description explicitly details physical components like reagent cartridges, calibrators, and controls, which are hardware and chemical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum". This is a classic description of an in vitro diagnostic test, which analyzes samples taken from the human body (in this case, serum) outside of the body.
- Sample Type: The device analyzes "human serum", which is a biological sample.
- Purpose: The results are used "to assist the clinician in the assessment of vitamin D sufficiency in an adult population". This indicates a diagnostic purpose.
- Device Description: The description details reagents, calibrators, and controls used to perform the test on an automated system. These are components typical of an IVD assay.
- Intended User / Care Setting: It is indicated for "In vitro diagnostic use only. Rx Only." This directly labels it as an IVD.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IDS iSYS 25-Hydroxy Vitamin DS Assay (IDS-iSYS 250HD*) is intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum on the IDS iSYS Multi-Discipline Automated System. 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.
The IDS-iSYS 25-Hydroxy Vitamin DS (25OHDS) Control Set is used for quality control of the IDSiSYS 25-Hydroxy Vitamin DS assay on the IDS-iSYS Multi-Discipline Automated System.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JJX
Device Description
The IDS-iSYS 25-Hydroxy Vitamin DS assay consists of a reagent cartridge and one set of calibrators (Calibrators A & B or CAL A & CAL B). The reagent cartridge contains multiple reagents: MPV1 (Magnetic particles coated with 25-OH D in a phosphate buffer containing methanol with sodium azide as preservative), CONJ (Anti- 25-OH D sheep polyclonal antibody labelled with an acridinium ester derivative, in buffer containing bovine, sheep, rabbit and mouse proteins with sodium azide as preservative), NaOH (Sodium hydroxide solution
§ 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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
IMMUNODIAGNOSTIC SYSTEMS LTD. MICK HENDERSON, RA OFFICER 10 DIDCOT WAY, BOLDON BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD UNITED KINGDOM
Re: K140554
Trade/Device Name: IDS-iSYS 25-Hydroxy Vitamin DS Assay IDS-iSYS 25-Hydroxy Vitamin D8 Control Set Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JJX Dated: November 10, 2014 Received: November 10, 2014
Dear Mr. 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.
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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/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No.0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140554
Device Name IDS-iSYS 25-Hydroxy Vitamin DS 1DS-iSYS 25-Hydroxy Vitamin DS Control Set
Indications for Use (Describe)
The IDS iSYS 25-Hydroxy Vitamin DS Assay (IDS-iSYS 250HD*) is intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum on the IDS iSYS Multi-Discipline Automated System. 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.
The IDS-iSYS 25-Hydroxy Vitamin DS (250HDS) Control Set is used for quality control of the IDSiSYS 25-Hydroxy Vitamin DS assay on the IDS-iSYS Multi-Discipline Automated System.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) SUMMARY
| 510k Number | K140554 |
|---|---|
| Introduction | According to the requirements of 21CFR807.92, the following |
| information provides sufficient detail to understand the basis for a | |
| determination of substantial equivalence. | |
| 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: 17, December 2014 |
| Device Name | Proprietary names: IDS-iSYS 25-Hydroxy Vitamin DS
IDS-iSYS 25-Hydroxy Vitamin DS Control Set |
| | Common names: As above |
| | Classification: 21CFR862.1825 Vitamin D Test System,
Class II
21CFR862.1660 Quality Control Material
(Assayed and Unassayed),
Class I, reserved |
| | Product Code: MRG |
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| Predicate Device | The IDS-iSYS 25-Hydroxy Vitamin DS is substantially equivalent to
other products in commercial distribution intended for similar use. We
claim equivalency to the currently marketed IDS-iSYS 25-Hydroxy
Vitamin D (K091849). |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The IDS-iSYS 25-Hydroxy Vitamin DS assay consists of a reagent
cartridge and one set of calibrators (Calibrators A & B or CAL A &
CAL B). The reagent cartridge contains multiple reagents: MPV1
(Magnetic particles coated with 25-OH D in a phosphate buffer
containing methanol with sodium azide as preservative), CONJ (Anti-
25-OH D sheep polyclonal antibody labelled with an acridinium ester
derivative, in buffer containing bovine, sheep, rabbit and mouse
proteins with sodium azide as preservative), NaOH (Sodium hydroxide
solution 40mg/dL might lead to falsely depressed values. Do not use hemolyzed samples.
- Assay cut-off: f.
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
A method comparison study was performed to demonstrate the accuracy of the newly aligned assay. With the aligned assay calibration parameters, 99 samples in the range of 9.0ng/mL to 98.6ng/mL, by ID-LC-MS/MS RMP, were used to assess the IDSiSYS 25-Hydroxy Vitamin D assay traceability against the ID-LC-MS/MS RMP.
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The relationship between the IDS-iSYS (y) and the ID-LC-MS/MS RMP (x) is described using Passing-Bablok regression & Deming regression:
Passing Bablok regression: IDS-iSYS = 0.95 x (ID-LC-MS/MS RMP)+ 0.80ng/mL 95 % CI of the slope: 0.86 to 1.04 95 % CI of the intercept: -1.32 to 3.08ng/mL
Deming regression: IDS-iSYS = 0.94 x (ID-LC-MS/MS RMP)+1.34ng/mL 95 % CI of the slope: 0.86 to 1.01 95 % CI of the intercept: -0.78 to 3.45ng/mL
Pearson correlation coefficient, r: 0.925
In addition, the following method comparison study was performed to characterize the comparison of the newly aligned IDS-iSYS 25-Hydroxy Vitamin De assay to the unaligned IDS-iSYS 25-Hydroxy Vitamin D assay:
Method comparison studies were performed following CLSI EP9-A2. An internal method comparison study was performed with a total of 283 European-sourced serum samples tested in singlicate on the IDS-iSYS 25-Hydroxy Vitamin D Assay and the predicate (the IDS-iSYS 25-Hydroxy Vitamin D Assay). Samples spanned the assay range with values from 7.3 -115.1 ng/mL (candidate values).
Passing-Bablok regression analysis was performed to produce a summary of results for each study, as shown below.
| Passing Bablok | y = 0.96x + 1.1ng/mL |
|---|---|
| Slope, 95% Confidence Interval | 0.91 to 1.01 |
| Intercept, 95% Confidence Interval | -0.3 to 2.3ng/mL |
| Correlation Coefficient, r | 0.94 |
| n | 283 |
| Range | 7.3 to 115.1 ng/mL |
Internal Study:
-
a. Matrix comparison:
Not applicable. Only serum may be used. -
- Expected values/Reference range:
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An expected values study performed according to the non-parametric method in CLSI protocol C28-A2.
Samples from 275 apparently healthy light skin and dark skin male and female adults living in the United States, aged 21 to 77 years, in geographical diverse regions of the United States to represent a broad spectrum of UV light exposure in the intended population were assayed in the IDS-iSYS 25-Hydroxy Vitamin DS Assay.
The 95% reference interval was calculated by a non-parametric method following C28-A2. The following range was obtained:
Normal Adults 12.7 - 64.2ng/mL (n=275)
| n | Observed Sample Range | Median | |
|---|---|---|---|
| Non-supplemented | 220 | 11.9 - 91.9ng/mL | 31.8ng/mL |
| Northern US | 116 | 11.9 - 55.4ng/mL | 29.7ng/mL |
| Southern US | 104 | 14.3 - 91.9ng/mL | 36.3ng/mL |
| Supplemented | 55 | 8.2 - 83.8ng/mL | 35.3ng/mL |
| Overall | 275 | 8.2 - 91.9ng/mL | 32.5ng/mL |
Observed sample ranges were:
The package insert states that there is no universal agreement on the optimal concentration of 250HD. Ranges should be based on clinical decision values that apply to both sexes of all ages rather than population based reference ranges for 25OHD.
Conclusion:
The IDS-iSYS 25-Hydroxy Vitamin DS and IDS-iSYS 25-Hydroxy Vitamin DS Control Set data presented and provided is complete and supports the basis for substantial equivalence to the predicate device.