ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5

Q: Who is the manufacturer of ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5?

Roche Diagnostics filed the 510(k) submission for ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 (K113546).

Q: What is the FDA product code for ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5?

MRG. It is classified under 21 CFR 862.1825 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5?

Abbott Architect 25-OH Vitamin D (K110619); Elecsys hGH CalSet (K103221); PreciControl Multimarker (K102157); Elecsys T4 CalCheck 5 (K112528).

Q: Who can help prepare an FDA 510(k) submission like ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K113546 · Roche Diagnostics · MRG · Jul 24, 2012 · Clinical Chemistry

Device Facts

Record ID	K113546
Device Name	ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
Applicant	Roche Diagnostics
Product Code	MRG · Clinical Chemistry
Decision Date	Jul 24, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1825
Device Class	Class 2

Intended Use

The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxy vitamin D in human serum and plasma. The Elecsys Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on Elecsys and Cobas e immunoassay analyzers. Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers. The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys Vitamin D assay is a competitive electrochemiluminescence immunoassay for use on Elecsys and cobas e analyzers. The device processes human serum or plasma samples; pretreatment reagents release endogenous vitamin D from binding proteins. Ruthenium-labeled vitamin D binding protein binds to the sample's vitamin D; biotinylated vitamin D is added to occupy remaining binding sites. Streptavidin-coated microparticles capture the biotinylated complex. The analyzer measures electrochemiluminescence emission to quantify total 25-hydroxy vitamin D. Results are calculated via a 2-point calibration curve. The assay aids clinicians in assessing vitamin D sufficiency in adult patients. The system includes dedicated calibrators (CalSet), controls (PreciControl Varia 3), and calibration verification materials (CalCheck 5).

Clinical Evidence

Bench testing only. Performance evaluated via precision (within-run CV 1.6-7.2%, total CV 2.9-10.3%), analytical sensitivity (LoB 2.00 ng/mL, LoD 3.00 ng/mL, LoQ 5.00 ng/mL), and specificity. Method comparison against LC-MS/MS (n=290, r=0.85) and Abbott Architect (n=165, r=0.91) provided. No clinical prospective/retrospective studies on patient outcomes reported.

Technological Characteristics

Competitive protein binding immunoassay. Reagents: dithiothreitol, NaOH, streptavidin-coated microparticles, ruthenium-labeled vitamin D binding protein, biotinylated vitamin D. Energy source: electrochemiluminescence. Form factor: automated analyzer-based (cobas e411). Connectivity: analyzer-integrated. Standardization: traceable to LC-MS/MS and NIST standards.

Indications for Use

Indicated for quantitative determination of total 25-hydroxyvitamin D in human serum and plasma as an aid in assessing vitamin D sufficiency in adults. For prescription use on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

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.

Predicate Devices

Abbott Architect 25-OH Vitamin D (K110619)
Elecsys hGH CalSet (K103221)
PreciControl Multimarker (K102157)
Elecsys T4 CalCheck 5 (K112528)

Related Devices

K210901 — Elecsys Vitamin D total III · Roche Diagnostics · Sep 1, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name, Address, Contact | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 (317) 521-2458 Contact Person: Michael Leuther, PhD, MBA Date Prepared: July 18, 2012 | | Device Name | Proprietary name: (1) Elecsys Vitamin D Assay (2) Elecsys Vitamin D CalSet (3) Elecsys PreciControl Varia 3 (4) Elecsys Vitamin D CalCheck 5 Common name: (1) Vitamin D Assay (2) Vitamin D Calibrator (3) Vitamin D Control (4) Vitamin D CalCheck 5 Classification name: (1) System, Test, Vitamin D (2) Calibrator, Secondary (3) Multi-analyte controls, all kinds (Assayed and Unassayed) (4) Single (specified) analyte controls (Assayed and Unassayed) | . · . : {1}------------------------------------------------ ### 510(k) Summary, Continued #### Device Description (1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code. (2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. . (3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes: | Assay Name | FDA Clearance Number for Reagents | |---------------------------------------------------------|--------------------------------------| | Vitamin B12 | K060755 | | Ferritin | K971833 | | Folate III | K082340 | | βCrossLaps/Serum (-CTx) | K993706 | | Osteocalcin | K051297 | | Parathyroid Hormone | K070709 | | Parathyroid Hormone Short Turnaround Time (PTH-STAT) | K070709 | (4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum. Note: The reagent, calibrator, and the quality control materials are all packaged separately. {2}------------------------------------------------ # 510(k) Summary, Continued | Intended Use/Indications for Use | • Elecsys Vitamin D Reagent: The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers. | | | • Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 is used for quality control of the specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. | | | • Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers. | {3}------------------------------------------------ ### 510(k) Summary, Continued Substantial The Elecsys Vitamin D Test System is substantially equivalent to other -Equivalence devices legally marketed in the United States. (1) Elecsys Vitamin D Assay is equivalent to the Abbott Architect 25-OH Vitamin D assay (K110619). (2) Elecsys Vitamin D CalSet is equivalent to the standards contained in the Elecsys hGH CalSet (K103221) (Human Growth Hormone). (3) Elecsys PreciControl Varia 3 is equivalent to the controls contained in the PreciControl Multimarker (K102157). (4) The Elecsys Vitamin D CalCheck 5 is equivalent to the Elecsys T4 CalCheck 5 (K112528). {4}------------------------------------------------ ### Premarket Notification, 510(k) for Elecsys Vitamin D Test System ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の | Substantial Equivalence - Comparison | The following table compares the Elecsys Vitamin D Test System with the predicate device. The next three tables compare the Elecsys Vitamin D CalSet, CalCheck 5, and PreciControl Varia 3 to their predicates. | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### Comparison of Assays, Similarities and Differences Premarket Notification, 510(k) for Elecsys Vitamin D Test System | | Assay Comparison | | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | General Assay Features | | | | Intended Use/ Indications for Use | The Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. | The Abbott Architect 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum or plasma. The Architect 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. | | Assay Protocol | Quantitative protein binding assay | Quantitative chemiluminescence immunoassay | | Detection Protocol | Electrochemiluminescence | Chemiluminescence | | Applications | 27 minute application | 36 minutes (time to first result) | {5}------------------------------------------------ #### Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued . | Assay Comparison | | | | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | | | General Assay Features | | | | | | Instrument Platform | Elecsys 2010 and cobas e 411 | Abbott Architect 25-OH Vitamin D | | | | Sample Volume | 15 uL | 60 uL for first run, 10 uL for additional runs | | | | Sample Type | Human serum and plasma treated with K2-EDTA, K3-EDTA or lithium heparin. | Human serum, plasma treated with lithium heparin, sodium heparin, potassium EDTA, or sodium citrate. | | | | Reagents | The Elecsys Vitamin D assay is a competitive binding assay which includes vitamin D (25-OH) labeled with biotin, and a ruthenium labeled vitamin D binding protein, and streptavidin coated microparticles. | The Abbott Architect 25-OH Vitamin D assay is a competitive one-step delayed immunometric assay which includes anti-vitamin D coated microparticles, an assay diluent, and biotinylated vitamin D anti-biotin acridinium labeled conjugate. | | | | Calibrator | Elecsys Vitamin D CalSet, 2 levels | Architect 25-OH Vitamin D Calibrators, 6 levels | | | Comparison of Assays—Similarities and Differences, continued {6}------------------------------------------------ #### Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued · #### Comparison of Assays-Similarities and Differences, continued | Assay Comparison | | | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows: After 1 month (28 days) when using the same reagent lot. After 7 days (when using the same reagent kit on the analyzer). As required: e.g. quality control findings outside the specified limits | Calibration must be performed: After 7 days When a control value is out of range | | Controls | Elecsys PreciControl Varia 3 | Architect 25-OH Vitamin D Controls | {7}------------------------------------------------ ## Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued Comparison of Assays-Similarities and Differences, continued | Assay Comparison | | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | General assay features | | | | Traceability / Standardization | The Elecsys Vitamin D Assay has been standardized against LC-MS/MS which in turn has been standardized to the NIST standard. | Architect 25-OH Vitamin D is traceable to a manufacturer's internal standard (Primary Calibrator), which is anchored against Absorbance at 264 nm. | | Reagent Stability | Unopened at 2-8 oC-up to stated expiration date After opening at 2-8 oC—56 days On the Elecsys 2010 and cobas e 411—21 days | Unopened at 2-8 oC-up to stated expiration date. After opening: on-board the analyzer for 14 days | {8}------------------------------------------------ #### System, Continued Comparison of Assays-Similarities and Differences, continued | Assay Comparison | | | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | Labeled Performance Characteristics | | | | Measuring Range | 5-60 ng/mL | 13-96 ng/mL | | Precision | Elecsys 2010/ cobas e 411: Within-run (will be labeled Repeatability) n=84, human sera 7.2% CV @ 6.2 ng/mL 5.1% CV @ 11.2 ng/mL 2.9% CV @ 23.2 ng/mL 2.4% CV @ 45.3ng/mL 1.6% CV @ 52.6 ng/mL Total (will be labeled Intermediate) 10.3% CV @ 6.2 ng/mL 7.6% CV @ 11.2 ng/mL 5.3% CV @ 23.2 ng/mL 3.4% CV @ 45.3ng/mL 2.9% CV @ 52.6 ng/mL | Abbott Architect 25-OH Vitamin D Within-run n=80, human sera 3.1% CV @ 23.0 ng/mL 2.6% CV @ 42.5 ng/mL 1.4% CV @ 75.4 ng/mL Total 4.0% CV @ 23.0 ng/mL 3.2% CV @ 42.5 ng/mL 2.7% CV @ 75.4 ng/mL | {9}------------------------------------------------ : ### Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued #### Comparison of Assays-Similarities and Differences, continued | Assay Comparison | | | | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | | | | Labeled Performance Characteristics | | | | | Analytical Sensitivity | Limit of Blank (LoB) 2.00 ng/mL Limit of Detection (LoD) 3.00 ng/mL Limit of Quantitation (LoQ) 5.00 ng/mL | Limit of Blank: 1.9 ng/mL Limit of Detection: 3.1 ng/mLL Limit of Quantitation (LoQ) 8.0 ng/mL | | | | Analytical Specificity | Cross Reactant 25-hydroxyvitamin D3 25-hydroxyvitamin D2 24,25-hydroxyvitamin D3 1,25-hydroxyvitamin D3 1,25-hydroxyvitamin D2 Vitamin D3 Vitamin D2 C3-epimer of 25- hydroxyvitamin D3 | Cross Reactant Cross Reactivity (%) 100 92 149 not detected not detected not detected not detected 91 | Cross Reactant 25-hydroxyvitamin D3 25-hydroxyvitamin D2 24,25-hydroxyvitamin D3 1,25-hydroxyvitamin D3 1,25-hydroxyvitamin D2 Vitamin D3 Vitamin D2 C3-epimer of 25- hydroxyvitamin D3 | Cross Reactivity (%) 105 82 112 12.6 Not tested 0.3 0.1 2.7 | | Hook Effect | There is no high-dose hook effect since the Elecsys Vitamin D assay is a competitive assay | Unknown | | | | Limitations | The assay is unaffected by: • Hemoglobin < 2 g/L • Bilirubin up ≤ 66 mg/dL • Lipemia < 400 mg/dL • Biotin < 70 ng/mL • HAMA and Rheumatoid factors were not assessed because the assay does not utilize antibodies | The assay is unaffected by: • Hemoglobin <200 mg/dL • Bilirubin up < 20 mg/dL • Triglycerides < 5000 mg/dL • Biotin not tested • HAMA<1000 ng/mL • Rheumatoid Factor <400 IU/mL | | | {10}------------------------------------------------ ### System, Continued Comparison of Assays-Similarities and Differences, continued | Assay Comparison | | | | | |---------------------------------------------|-------------------------|-------|--------------------------------------------------------------------|------| | Feature | Elecsys Vitamin D Assay | | Predicate Device: Abbott Architect 25-OH Vitamin D (K110619) | | | Labeled Performance Characteristics | | | | | | Method Comparison (LC-MS/MS vs. Elecsys) | Deming(n=290) | Slope | Intercept | r | | | | 1.03 | -3.07 | 0.85 | | Method Comparison Abbott vs. Elecsys) | Deming(n=165) | Slope | Intercept | r | | | | 0.99 | 1.20 | 0.91 | {11}------------------------------------------------ System, Continued Comparison of CalSet Materials | Characteristic | CalSet for Elecsys Vitamin D Assay | Predicate Device: Elecsys hGH CalSet (K103221) | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Elecsys Vitamin D CalSet is used for calibrating the quantitative Elescys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers. | Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGH assay on the Elecsys and cobas e immunoassay analyzers. | | Levels | Two | Same | | Matrix | Human serum | Same | | Format | Lyophilized | Same | | Stability | Unopened: • Store at 2 - 8 °C up to the stated expiration date. After reconstitution: • At 2 - 8°C: 120 hours • At -20°C: 90 days (freeze only once). • On Elecsys 2010/cobas e 411 at 20 - 25°C: Up to 5 hours. | Unopened: • Store at 2 - 8 °C up to the stated expiration date. After reconstitution: • At 2 - 8 °C: 7 days • At -20°C: 28 days (freeze only once). • On Elecsys 2010/cobas e 411 at 20 - 25°C: Up to 5 hours. On MODULAR ANALYTICS E170/cobas e 601: Use only once. | | Handling | Dissolve the contents of one bottle carefully by adding exactly 1.0 mL of distilled water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam. Transfer the reconstituted calibrator into the empty labeled snap- cap bottles supplied. | Dissolve carefully the contents of one bottle by adding exactly 1.0 mL of distilled or deionized water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam. Transfer the reconstituted calibrator into the empty labeled snap-cap bottle supplied. | | Characteristic | Elecsys PreciControl Varia 3 | Predicate Device: Elecsys PreciControl Multimarker (K102157) | | Intended Use | Elecsys PreciControl Varia 3 is used for quality control of Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. | Elecsys PreciControl Multimarker is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. | | Levels | Three | Two | | Format | Lyophilized | Same | | Matrix | Human serum | Equine serum | | Analyte Concentration | 25-hydroxyvitamin D (synthetic) in human serum at target values of approximately: V3 0: 12.8 ng/mL V3 1: 17 ng/mL V3 2: 32 ng/mL | C-Peptide (synthetic): Approximately 2 and 10 ng/mL. Insulin (human recombinant from yeast): Approximately 25 and 80 μU/mL. ACTH (synthetic): Approximately 50 and 1,000 pg/mL. hGH (human recombinant from E. coli): Approximately 1 and 10 ng/mL. | | Stability | Unopened: • Store at 2-8°C up to the stated expiration date Reconstituted: • 2 - 8°C: 72 hours • -20°C: 31 days(freeze only once) • On the analyzers at 20-25°C: up to 5 hours | Unopened: • Store at 2-8°C up to the stated expiration date Reconstituted: • 2 - 8°C: 72 hours • -20°C: 31 days (freeze only once) • On the analyzers at 20-25°C: up to 5 hours | | Handling | Carefully dissolve the contents of one bottle by adding exactly 3.0 mL of distilled or deionized water and allow to stand closed for 30 minutes to reconstitute. Mix carefully, avoiding the formation of foam. Transfer the reconstituted control into the empty, labeled snap-cap bottles supplied or freeze aliquots in additional snap-cap bottles (ControlSet Vials). Attach the supplied labels to these bottles. Perform only one control procedure per aliquot. | Dissolve carefully the contents of one bottle by adding exactly 2.0 mL of distilled or deionized water and allow to stand closed for 30 minutes to reconstitute. Mix carefully, avoiding the formation of foam. Transfer the reconstituted control into empty, labeled snap-cap bottles supplied (ControlSet Vials) and freeze aliquots immediately in additional ControlSet Vials. Attach the supplied labels to these additional bottles. Perform only one control procedure per aliquot. | | Characteristic | Elecsys Vitamin D CalCheck 5 | Predicate Device: Elecsys T4 CalCheck 5 (K112528) | | Intended Use | The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers. | The Elecsys T4 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers. | | Analyte | (25-OH) Vitamin D | Thyroxine (T4) | | Levels | Five | Same | | Matrix | Human serum | Check 1: BSA/Buffer matrix Check 2-5: human serum | | Format | Lyophilized | Same | | Handling | Reconstitute Check 1, Check 2, Check 3, Check 4 and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion to ensure homogeneity. | Same | | Stability | Unopened: Store at 2-8 °C until expiration date Reconstituted: 20-25 °C: 5 hours | Same | {12}------------------------------------------------ #### System, Continued Comparison of PreciControl Materials {13}------------------------------------------------ #### System, Continued Comparison of CalCheck 5 Materials ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . {14}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 JUL 2 4 2012 Roche Diagnostics c/o Michael Leuther, PhD, MBA Roche Professional Diagnostics 9115 Hague Road Indianapolis, IN 46250 RE: k113546 Trade Name: Elecsys Vitamin D Assay Elecsys Vitamin D CalSet Elecsys PreciControl Varia 3 Elecsys Vitamin D Calchek 5 Regulation Number: 21 CFR §862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Codes: MRG, JIT,JJY,JJX Dated: July 5, 2012 Received: July 6, 2012 Dear Dr. Leuther: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {15}------------------------------------------------ Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm Sincerely yours, Q. H. Liao, Ph.D. Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {16}------------------------------------------------ Confidential ### Indications for Use Form 510(k) Number (if known): Device Name: Elecsys Vitamin D Assay Indications for Use: The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxy vitamin D in human serum and plasma. The Elecsys Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K113546 Page 1 of 4 Page 33 of 264 {17}------------------------------------------------ Elecsys Vitamin D 510(K) Submission Confidential ## Indications for Use Form 510(k) Number (if known): _ Elecsys Vitamin D CalSet Device Name: Indications for Use: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Includions 10. On the Elecsys and cobas e immunoassay analyzers. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K113546 Page 2 of 4 Rage 34 of 264 {18}------------------------------------------------ Elecsys Vitamin D 510(K) Submission Confidential ## Indications for Use Form 510(k) Number (if known): Elecsys PreciControl Varia 3 Device Name: Indications for Use: Elecsys PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) i<113546 Page 3 of 4 Page 25 of 264 {19}------------------------------------------------ Elecsys Vitamin D 510(K) Submission Confidential Page 1 of __ ## Indications for Use Form 510(k) Number (if known): Elecsys Vitamin D CalCheck 5 Device Name: ____ Indications for Use: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration Incifications for USe. The Enceys ration of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ・・ Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K113546 Page 4 of 4 Page 36 of 264

ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5

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ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

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