(422 days)
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No
The device description details a radioimmunoassay (RIA) kit, a traditional laboratory method for measuring substances. The performance studies describe comparisons to other traditional methods (HPLC, CPBA) and use linear regression analysis, which are standard statistical techniques and do not indicate the use of AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a quantitative measurement kit for 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites, used for assessing vitamin D sufficiency, not for therapy.
Yes
The device is described as "intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency," which is a diagnostic purpose.
No
The device description clearly outlines a radioimmunoassay (RIA) kit, which involves physical reagents, sample preparation, and measurement of radioactivity. This is a hardware-based laboratory assay, 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 measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma". This indicates the analysis of biological samples in vitro (outside the body).
- Device Description: The description details a laboratory assay using reagents (antibodies, labeled analog, precipitating reagent) to analyze serum or plasma samples. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies compare the device's results to other laboratory methods (HPLC and CPBA) using serum samples, further confirming its use in a laboratory setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
The INCSTAR 25-Hydroxyvitamin D 125| RIA Kit is intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.
Product codes
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Device Description
This assay requires serum or plasma samples to be extracted with acetonitrile to free vitamin D and its metabolites which are almost completely associated with binding proteins as well as remove lipids which would interfere with the assay. Calibrators (kit standards) containing known concentrations of 25hydroxycholecalciferol (25-OH Vitamin D3) in a human serum matrix are likewise extracted. The primary antibody (goat anti-25-OH vitamin D) selected for use in the assay demonstrates high affinity and equal cross-reactivity to both 25(OH)D2 and 25(OH)Da but very low cross-reactivity to non-hydroxylated vitamin D2 or D3 and 1.25(OH)2 D. The primary antiserum used in the assay does recognize several other dihvdroxylated metabolites of vitamin D; however, these metabolites are found in relatively low concentrations in the circulation and are believed to be of minor biological importance. During the assay reaction, samples compete with an 1251 labeled analog of 25-OH D3 for binding sites on the primary antiserum. Phase separation is accomplished using a donkey anti-goat, polyethylene glycol precipitating reagent. The amount of radioactivity contained in the resulting precipitate is inversely proportional to the concentration of 25-OH-D present in the sample.
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
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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
The INCSTAR 25-Hydroxyvitamin D 1251 RIA Kit has been shown to be substantially equivalent to CPBA and HPLC methods used to determine levels of 25-OH-D. CPBA methods for measuring 25-OH-D have been used by commercial, clinical laboratories prior to the Medical Device Amendments of 1976. Furthermore, both methods have been compared to HPLC and have shown comparable results. The INCSTAR 25-Hydroxyvitamin D 1491 RIA kit was compared to HPLC (High Pressure Liguid Chromatography), and CPBA (Competitive Protein Binding Assay) 25-OH-D methods. Various patient groups representing a wide range of 25-OH-D values were assayed using the INCSTAR kit, CPBA, and (in one study) HPLC. Results were analyzed using linear regression analysis.
The first study was performed by two external sites. Each site analyzed 36 serum samples using the INCSTAR kit, HPLC and CPBA. Results from both sites were combined (n=72). Values ranged from 4.7 to 186 ng/mL and gave the following results:
INCSTAR = 0.954 (HPLC) + 1.327; correlation coefficient = 0.993
INCSTAR = 0.998 (CPBA) - 0.639; correlation coefficient = 0.981
The second study, performed by one external site, analyzed 106 serum samples using the INCSTAR kit and CPBA. Results ranged from 7.4 to 461 ng/mL and gave the following results:
INCSTAR = 1.229 (CPBA) - 5.092; correlation coefficient = 0.942
Key Metrics
correlation coefficient = 0.993
correlation coefficient = 0.981
correlation coefficient = 0.942
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
SEP 2 5 1996
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Attachment 4
SUMMARY OF SAFETY AND EFFECTIVENESS
1
SUMMARY OF SAFETY AND EFFECTIVENESS
INCSTAR 25-Hydroxyvitamin D 125| RIA DEVICE NAME:
CI ASSIFICATION NAME: 25-Hydroxyvitamin D Test System
APPLICANT: INCSTAR Corporation 1990 Industrial Boulevard Stillwater. MN 55082-0285
July 26, 1995 DATE:
The INCSTAR 25-Hydroxyvitamin D 1251 RIA Kit is intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.
This assay requires serum or plasma samples to be extracted with acetonitrile to free vitamin D and its metabolites which are almost completely associated with binding proteins as well as remove lipids which would interfere with the assay. Calibrators (kit standards) containing known concentrations of 25hydroxycholecalciferol (25-OH Vitamin D3) in a human serum matrix are likewise extracted. The primary antibody (goat anti-25-OH vitamin D) selected for use in the assay demonstrates high affinity and equal cross-reactivity to both 25(OH)D2 and 25(OH)Da but very low cross-reactivity to non-hydroxylated vitamin D2 or D3 and 1.25(OH)2 D. The primary antiserum used in the assay does recognize several other dihvdroxylated metabolites of vitamin D; however, these metabolites are found in relatively low concentrations in the circulation and are believed to be of minor biological importance. During the assay reaction, samples compete with an 1251 labeled analog of 25-OH D3 for binding sites on the primary antiserum. Phase separation is accomplished using a donkey anti-goat, polyethylene glycol precipitating reagent. The amount of radioactivity contained in the resulting precipitate is inversely proportional to the concentration of 25-OH-D present in the sample.
The INCSTAR 25-Hydroxyvitamin D 1251 RIA Kit has been shown to be substantially equivalent to CPBA and HPLC methods used to determine levels of 25-OH-D. CPBA methods for measuring 25-OH-D have been used by commercial, clinical laboratories prior to the Medical Device Amendments of 1976. Furthermore, both methods have been compared to HPLC and have shown comparable results.
The INCSTAR 25-Hydroxyvitamin D 1491 RIA kit was compared to HPLC (High Pressure Liguid Chromatography), and CPBA (Competitive Protein Binding Assay) 25-OH-D methods. Various patient groups representing a wide range of 25-OH-D values were assayed using the INCSTAR kit, CPBA, and (in one study) HPLC. Results were analyzed using linear regression analysis.
2
The first study was performed by two external sites. Each site analyzed 36 serum samples using the INCSTAR kit, HPLC and CPBA. Results from both sites were combined (n=72). Values ranged from 4.7 to 186 ng/mL and gave the following results:
INCSTAR = 0.954 (HPLC) + 1.327; correlation coefficient = 0.993
INCSTAR = 0.998 (CPBA) - 0.639; correlation coefficient = 0.981
The second study, performed by one external site, analyzed 106 serum samples using the INCSTAR kit and CPBA. Results ranged from 7.4 to 461 ng/mL and gave the following results:
INCSTAR = 1.229 (CPBA) - 5.092; correlation coefficient = 0.942