← Product Code [MRG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG) · K953567 # INCSTAR 25-HYDROXYVITMIN D 1251 RIA (K953567) _Incstar Corp. · MRG · Sep 25, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K953567 ## Device Facts - **Applicant:** Incstar Corp. - **Product Code:** [MRG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG.md) - **Decision Date:** Sep 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1825 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The INCSTAR 25-Hydroxyvitamin D 125I 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. ## Device Story INCSTAR 25-Hydroxyvitamin D 125I RIA is a radioimmunoassay (RIA) kit for quantitative measurement of 25-hydroxyvitamin D and metabolites in human serum or plasma. Procedure: samples extracted with acetonitrile to release metabolites from binding proteins and remove lipids; extracted samples compete with 125I-labeled 25-OH D3 analog for binding sites on goat anti-25-OH vitamin D primary antibody. Phase separation uses donkey anti-goat, polyethylene glycol precipitating reagent. Radioactivity in precipitate is inversely proportional to 25-OH-D concentration. Used in clinical laboratories by technicians. Results assist clinicians in assessing patient vitamin D sufficiency. ## Clinical Evidence Bench testing and comparative clinical studies performed. Study 1 (n=72): INCSTAR vs HPLC (r=0.993) and INCSTAR vs CPBA (r=0.981). Study 2 (n=106): INCSTAR vs CPBA (r=0.942). Results analyzed via linear regression; demonstrated comparable performance to established CPBA and HPLC methods. ## Technological Characteristics Radioimmunoassay (RIA) utilizing 125I-labeled 25-OH D3 analog. Reagents: goat anti-25-OH vitamin D primary antibody, donkey anti-goat/polyethylene glycol precipitating reagent. Extraction solvent: acetonitrile. Measurement principle: competitive binding with radioactivity detection inversely proportional to analyte concentration. ## Regulatory 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. ## Special Controls *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. ## Reference Devices - CPBA (Competitive Protein Binding Assay) methods - HPLC (High Pressure Liquid Chromatography) methods ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K953567 SEP 25 1996 # Attachment 4 # SUMMARY OF SAFETY AND EFFECTIVENESS {1} U SUMMARY OF SAFETY AND EFFECTIVENESS DEVICE NAME: INCSTAR 25-Hydroxyvitamin D $^{125}$I RIA CLASSIFICATION NAME: 25-Hydroxyvitamin D Test System APPLICANT: INCSTAR Corporation 1990 Industrial Boulevard Stillwater, MN 55082-0285 DATE: July 26, 1995 The INCSTAR 25-Hydroxyvitamin D $^{125}$I 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 25-hydroxycholecalciferol (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)D3 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 dihydroxylated 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 $^{125}$I 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 $^{125}$I 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 $^{125}$I RIA kit was compared to HPLC (High Pressure Liquid 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: $$ \text{INCSTAR} = 0.954 \, (\text{HPLC}) + 1.327; \text{ correlation coefficient} = 0.993 $$ $$ \text{INCSTAR} = 0.998 \, (\text{CPBA}) - 0.639; \text{ correlation coefficient} = 0.981 $$ 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: $$ \text{INCSTAR} = 1.229 \, (\text{CPBA}) - 5.092; \text{ correlation coefficient} = 0.942 $$ --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K953567](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K953567) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com