(75 days)
DiaSorin 25-Hydroxyvitamin D 125I RIA kit
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No
The summary describes a standard immunoassay for measuring vitamin D metabolites. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies are based on traditional statistical methods for assay validation.
No
Explanation: This device is an in-vitro diagnostic assay used for the quantitative determination of 25-hydroxyvitamin D. It provides information for diagnosis and assessment, but it does not treat or cure a disease or condition.
Yes
The device is an "aid in the assessment of vitamin D sufficiency" and its results "should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions." This indicates its purpose is to aid in diagnosis or assessment of a medical condition.
No
The device description explicitly states it contains "sufficient reagents for 100 tests" and is an "automated 25-OH-D assay for use only on the Nichols Advantage Immunoassay System," indicating it is a hardware-based immunoassay system that utilizes reagents, not a software-only device.
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 (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma". Serum and plasma are biological specimens taken from the human body.
- Purpose: The purpose is to be "used as an aid in the assessment of vitamin D sufficiency in an adult population". This is a diagnostic purpose, providing information about a patient's health status.
- Device Description: It's described as an "automated 25-OH-D assay", which is a type of test performed on biological samples.
- Performance Studies: The document details performance studies like method comparison and a clinical study, which are typical for IVD devices to demonstrate their accuracy and clinical utility.
The definition of an In Vitro Diagnostic (IVD) device is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
The Nichols Advantage® 25-Hydroxyvitamin D assay is intended for the quantitative determination of 25-hydrxoyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
Product codes
MRG, JIT, JJX
Device Description
The Nichols Advantage 25-OH-D (NA 25-OH-D) contains sufficient reagents for 100 tests. The NA 25-OH-D is an automated 25-OH-D assay for use only on the Nichols Advantage Immunoassay System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult population
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Clinical Study: Patients (n=100) with a diagnosis of chronic renal insufficiency were evaluated with the NA 25-OH-D. Using a cutoff of 20 ng/mL, the results demonstrate the assay recognizes vitamin D deficiency and vitamin D insufficiency, consistent with biochemical measures of disordered calcium mineral ion metabolism. As renal failure becomes progressive worse, the frequency of low 25-0H-D levels increases as do biochemical measures of worsening indices of calcium mineral ion metabolism.
Comparison to Predicate Device:
Study type: Split sample method comparison study following the NCCLS EP9-A quidelines.
Sample size: N=99 samples. For n=80 samples within the reportable ranges of each method, the Passing & Bablok method comparison demonstrates: Y=1.1(X) - 0.6 (95% cf slope: 0.94 to 1.27; 95% cf intercept: -4.6 to 2.1), and a Pearson correlation r=0.84 (95%cf: 0.76-0.89). For the entire n=99 samples, relative agreement using a cut-off of 20 ng/mL or greater was 91%, and the relative agreement for values less than 20 ng/mL was 98%, with an overall agreement of 94%.
Method comparison against DiaSorin 25-Hydroxyvitamin D 125RIA kit following NCCLS Method Comparison (EP9A) procedures.
Sample size: n=111 total samples assayed, each in duplicate, over 3 days in 3 different runs. 80 samples were within the reportable ranges of each method and demonstrated acceptable levels of imprecision. 12 samples deleted due to unacceptable imprecision (>4 sd). 19 samples were below the reportable range (80.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Key Metrics
Sensitivity: Analytical: 4 ng/mL, Functional: 7 ng/mL
Within-Run Precision (%CV): 3.0-4.5%
Total Precision (%CV): 6.4-14.5%
Recovery: 90-99%
Linearity: 80-109%
Specificity @ 50% B/Bo:
Vitamin D2 = 1.6%
Vitamin D3 = 1.2%
25-OH-D2 = 100%
25-OH-D3 = 100%
24,25(OH)2D3 = 100%
25-26-OH2D3 = 39%
1,25(OH)2D3 = 1.1%
Relative agreement at 20 ng/mL or less: [45/(45+1)] x 100 = 97.8%
Relative agreement at 20 ng/mL and higher: [48/(5+48)] x 100 = 90.6%
Overall agreement using 20 ng/mL as the cutoff: [45+48/99] x 100 = 93.9%
Predicate Device(s)
DiaSorin 25-Hydroxyvitamin D 125I RIA kit
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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510(k) Summary 12.0
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Name of Manufacturer, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675 Phone: 949-240-5260 FAX: 949-240-5313 Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: September 20, 2001
2. Device Name:
| Trade/Proprietary Name: | Nichols Advantage® 25-Hydroxyvitamin D |
|---|---|
| Common Name: | 25-OH-D Immunoassay |
| Classification Name: | Vitamin D test system |
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Classification: Class II ട്.
Regulation Number: 862.1825 Product Code: MRG. Clinical Chemistry -
DiaSorin 25-Hydroxyvitamin D 1251 RIA kit 4. Predicate Device:
Device Description: 5.
The Nichols Advantage 25-OH-D (NA 25-OH-D) contains sufficient reagents for 100 tests. The NA 25-OH-D is an automated 25-OH-D assay for use only on the Nichols Advantage Immunoassay System.
Intended Use: 6.
The Nichols Advantage® 25-Hydroxyvitamin D assay is intended for the quantitative determination of 25-hydrxoyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
7. Comparison to Predicate Device:
The Nichols Advantage 25-OH-D (Y) is substantially equivalent to the DiaSorin 25-Hydroxvyitamin D 125] RIA kit (X). N=99 samples were used in a split sample method comparison study following the NCCLS EP9-A quidelines. For n=80 samples within the reportable ranges of each method, the Passing & Bablok method comparison demonstrates: Y=1.1(X) - 0.6 (95% cf slope: 0.94 to 1.27; 95% cf intercept: -4.6 to 2.1), and a Pearson correlation r=0.84 (95%cf: 0.76-0.89). For the entire n=99 samples, relative agreement using a cut-off of 20 ng/mL or greater was 91%, and the relative agreement for values less than 20 ng/mL was 98%, with an overall agreement of 94%.
8. Clinical Study
Patients (n=100) with a diagnosis of chronic renal insufficiency were evaluated with the NA 25-OH-D. Using a cutoff of 20 ng/mL, the results demonstrate the assay recognizes vitamin D deficiency and vitamin D insufficiency, consistent with biochemical measures of disordered calcium mineral ion metabolism. As renal failure becomes progressive worse, the frequency of low 25-0H-D levels increases as do biochemical measures of worsening indices of calcium mineral ion metabolism.
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9. Similarities:
- Intended use for each assay is identical. .
- Both assays use 25-OH-D3 in their standards, and both report values using the same units: ● ng/mL.
- Both assay use the competitive ligand binding technique. .
- Both assays are capable of using serum, EDTA and heparinized plasma as samples. .
10. Differences:
The following differences pertain to differences in immunoassay technology and do not affect the intended uses of the NA 25-OH-D assay.
| Feature | Nichols 25-OH-D | DiaSorin 25-OH-D |
|---|---|---|
| Sample Size: | 20 uL serum or plasma | 50 ul serum or plasma |
| Solid Phase/Precipitating | ||
| Complex: | 25-OH-D3 magnetic particles | Donkey anti-goat + normal goat |
| serum + PEG precipitating | ||
| complex. | ||
| Label: | Acridinium-ester labeled Anti-DBP | $^{125}I$ analog o f 25-OH-D3 |
| Binder/Antibody: | Human vitamin D binding protein | Goat anti-25-OH-D |
| Technology | Automated, hands free set-up | |
| No extraction is required. | Manual procedure | |
| Separate extraction is required. | ||
| Incubation steps and temperature: | 21 minutes @ 37°C (25-OH-D | |
| displacement)+ 21 minutes @ | ||
| 37°C (assay incubation). | 90 minutes @ 20-25°C + 20 | |
| minutes @ 20-25°C + 20 minutes | ||
| centrifugation. | ||
| Reportable Range | 7-120 ng/mL | 5.0-100 ng/mL |
11. Comparison of Performance Characteristics
| Feature | Nichols 25-OH-D | DiaSorin 25-OH-D |
|---|---|---|
| Sensitivity | Analytical: 4 ng/mL | |
| Functional: 7 ng/mL | Analytical: ≤ 1.5 ng/mL | |
| Functional: 2.5 ng/mL (optional std.) | ||
| Within-Run Precision (%CV) | 3.0-4.5% | 8.6-12.5% |
| Total Precision (%CV) | 6.4-14.5% | 8.2-11.0% |
| Recovery | 90-99% | 92-119% |
| Linearity | 80-109% | 96-110% |
| Specificity @ 50% B/Bo | Vitamin D2 = 1.6% | |
| Vitamin D3 = 1.2% | ||
| 25-OH-D2 = 100% | ||
| 25-OH-D3 = 100% | ||
| 24,25(OH)2D3 = 100% | ||
| 25-26-OH2D3 = 39% | ||
| 1,25(OH)2D3 = 1.1% | Vitamin D2 = 0.8% | |
| Vitamin D3 = 0.8% | ||
| 25-OH-D2 = 100% | ||
| 25-OH-D3 = 100% | ||
| 24,25(OH)2D3 = 100% | ||
| 25-26-OH2D3 = 100% | ||
| 1,25(OH)2D3 = 11.0% |
Conclusions: These data, which were provided to FDA, demonstrate safety and effectiveness of the Nichols Advantage 25-Hydroxyvitamin D for the intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage 25-OH-D assay is substantially equivalent to the predicate method.
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10.5 Comparison to a Predicate Device
Method comparison was made against the DiaSorin 25-Hydroxyvitamin D 125RIA kit. Both the predicate device and the subject device were performed exactly as described by their respective manufacturer's directional inserts. The NCCLS Method Comparison (EP9A) procedures were followed. There were n=111 total samples assayed, each in duplicate. The samples were assayed over 3 days in 3 different runs, and guality control samples for each run were within their respective ranges. Of the 111 paired samples, 80 were within the reportable ranges of each method and demonstrated acceptable levels of imprecision. We used 4 standard deviations to delete outliers for reasons of imprecision. Twelve samples demonstrated unacceptable levels of imprecision (>4 sd) and were deleted. Nineteen samples were below the reportable range (80.1 | | | | | | | | |
DiaSorin 25-OH-D (no/ml )
Using a cutoff of 20 ng/mL or higher, the relative agreement between methods were calculated.
Relative agreement at 20 ng/mL or less: [45/(45+1)] x 100 = 97.8% Relative agreement at 20 ng/mL and higher: [48/(5+48)] x 100 = 90.6% Overall agreement using 20 ng/mL as the cutoff: [45+48/99] x 100 = 93.9%
Using a cutoff of 20 ng/mL as the lower limit for vitamin D sufficiency, the subject device demonstrates a relative agreement of 90.6% with the DiaSorin assay at 20 ng/mL and higher. This demonstrates that the subject device is substantially equivalent to the DiaSorin kit in detecting absence of low 25-OH-D levels for determining vitamin D sufficiency. For values below 20 ng/mL, the subject device demonstrates a relative agreement of 97.8% with the DiaSorin kit in identifying low 25-OH-D levels. The overall agreement was 93.9%.
In conclusion, these results in addition to the previous clinical study that evaluates levels of 25-OH-D in patients who are at great risk for vitamin D insufficiency and vitamin D deficiency demonstrate that this device is safe and effective for its intended use.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 92001
Mr. Jimmy Wong Manager. Clinical and Technical Affairs Nichols institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675
Re: K012367
Trade/Device Name: Nichols Advantage 25-Hydroxyvitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: JIT, MRG Regulatory Class: Class I, reserved Product Code: JJX Dated: September 26, 2001 Received: September 27, 2001
Dear Mr. Wong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and 1 IT you desire specific acrice for your dotic devices), please contact the Office of Compliance at additionally 607.10 for in Nue and successions on the promotion and advertising of your device, (301) 594-4568. Additionally, for quest (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Constant Constitution w.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications For Use Statement
| INDICATIONS FOR USE STATEMENT |
|---|
| ------------------------------- |
| 510(k) Number: | K012367 |
|---|---|
| ---------------- | --------- |
Nichols Advantage 25-Hydroxyvitamin D Device Name:
Indications for Use Statement: The Nichols Advantage® 25-Hydroxyvitamin D assay is for use only on the Nichols Advantage® Specialty System. The Nichols Advantage 25-Hydroxyvitamin D assay is intended 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 as an aid in the assessment of vitamin D sufficiency in an adult population. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or 510(k) Number
Over -The-Counter Use (Optional Format 1-2-96)