ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
Device Facts
| Record ID | K103716 |
|---|---|
| Device Name | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET |
| Applicant | Roche Diagnostics |
| Product Code | CGN · Clinical Chemistry |
| Decision Date | May 12, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1295 |
| Device Class | Class 2 |
Intended Use
The Elecsys Folate III assay is an in vitro immunoassay for the quantitative determination of folate in human serum and plasma. The electrochemiluminescence immunoassay (ECLIA) is intended for use on Elecsys and cobas e immunoassay analyzers.
Device Story
The Elecsys Folate RBC Test System is an in vitro diagnostic system for quantitative determination of folate in erythrocytes. It utilizes manually prepared hemolysate samples. The assay employs a competitive electrochemiluminescent immunoassay principle: folate in the sample competes with biotin-labeled folate for binding sites on ruthenium-labeled folate binding protein. The system is operated by laboratory professionals on Elecsys and cobas e immunoassay analyzers. Calibration is performed using the Elecsys Folate RBC CalSet, with verification via the Elecsys Folate RBC CalCheck. Results are generated via an instrument-specific calibration curve and a master curve encoded on the reagent barcode. Healthcare providers use these quantitative measurements to assist in diagnosing and treating anemias. The system provides standardized folate levels, aiding clinical decision-making regarding patient nutritional status and anemia management.
Clinical Evidence
Bench testing only. Verification and validation activities performed per design control procedures to confirm impact of calibrator matrix and standardization changes; results demonstrated adherence to predetermined acceptance criteria.
Technological Characteristics
Electrochemiluminescence immunoassay (ECLIA). Calibrator matrix: hemolysate-based. Analyzers: Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, cobas e 602. Reagent kit format: RBC Folate separated from serum/plasma kit.
Indications for Use
Indicated for use as an aid in the diagnosis and treatment of anemias. For in vitro diagnostic use on Elecsys and cobas e immunoassay analyzers.
Regulatory Classification
Identification
A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
Predicate Devices
- Roche Elecsys Folate III (K082340)
Related Devices
- K082340 — ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS · Roche Diagnostics Corp. · Jun 19, 2009
- K233060 — Elecsys Folate III · Roche Diagnostics · Jun 17, 2024
- K141426 — ELECSYS FOLATE III · Roche Diagnostics · Oct 17, 2014
Submission Summary (Full Text)
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K103716
Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate MAY 1 2 2011 RBC CalSet and the Folate RBC CalCheck)
## 510(k) Summary
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 Roche Diagnostics name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3723 Contact Person: Kathie J. Goodwin
Date Prepared: December 20, 2010
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Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate RBC CalSet and the Folate RBC CalCheck) Device Name Proprietary names: (1) Elecsys Folate RBC Assay (2) Elecsys Folate RBC CalSet and (3) Elecsys Folate RBC CalCheck
Device Descriptions (1) Folate RBC Assay (2) Folate RBC CalSet (3) Folate RBC CalCheck
### Classification names: (1) Folic Acid Test System (2) Calibrator, Secondary
(3) Quality Control Material (Assayed and Unassayed)
Product codes: (1) CGN (2) JIT (3) JJX
Common names:
(1) The Elecsys Folate RBC assay employs a competitive test principle using natural folate binding protein specific for folate. Manually prepared hemolysate samples are used with this assay. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on folate binding protein (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode encoded on the reagent packaging.
(2) The Elecsys Folate RBC CalSet is a lyophilized product consisting of human serum with folate in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate RBC assay.
(3) The Elecsys Folate RBC CalCheck is a lyophilized product consisting of a hemolysate with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate RBC CalSet.
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### Intended use Folate RBC Assay:
Binding assay for the in vitro quantitative determination of folate erythrocytes (red blood cells, RBCs). The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
### Folate RBC CalSet:
The Elecsys Folate RBC CalSet is used for calibrating the quantitative Elecsys Folate RBC assay on the Elecsys and cobas e immunoassay analyzers.
### Folate RBC CalCheck:
Elecsys Folate RBC CalCheck is used for the verification of the calibration established by the Elecsys Folate RBC reagent on the indicated Elecsys and cobas e immunoassay analyzers.
### Indications for Folate RBC Assay:
Use
Measurements obtained by this assay are used in the diagnosis and treatment of anemias.
### Folate RBC CalSet:
Elecsys Folate RBC CalSet is used for calibrating the quantitative Elecsys Folate RBC assay on the Elecsys and cobas e immunoassay analyzers.
### Folate RBC CalCheck:
Elecsys Folate RBC CalCheck is used for the verification of the calibration established by the Elecsys Folate RBC reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.
### Substantial The Elecsys Folate RBC Test System is substantially equivalent to the equivalence Elecsys RBC Folate III Test System. This test system was previously cleared in K082340.
Continued on next page ... ...
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Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate RBC CalSet and the Folate RBC CalCheck)
## 510(k) Summary, Continued
Substantial equivalence -comparison
| (1) Elecsys Folate RBC Assay | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Elecsys Folate RBC Assay | Predicate Device: Elecsys RBC Folate III Assay (K082340) |
| Intended Use | Elecsys Folate RBC binding assay is used for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). The assay is intended for use on Elecsys and cobas e immunoassay analyzers. | Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erythrocytes (Red blood cell folate; RBC folate) on the Elecsys 2010 and cobas e 411 immunoassay analyzers. |
| Indication for Use | Same | This assay may be used as an aid in the diagnosis and treatment of anemias. |
| Assay Protocol | Same | Electrochemiluminescent Immunoassay |
| Sample Type | Same | Na-Heparin and K3-EDTA |
| Labeled Instrument Platform | Roche Elecsys 2010/ cobas e 411 and Modular E170/cobas e 601/602 analyzers | Roche Elecsys 2010/ cobas e 411 analyzers |
| Calibrator | Elecsys Folate RBC CalSet | Elecsys Folate III CalSet |
| Calibration frequency | Same | Once per reagent lot and<br>• After 1 month when using same reagent lot<br>• After 7 days when using same reagent kit on the analyzer<br>• As required per QC findings or pertinent regulations |
| Controls | Commercially available whole blood control | Elecsys PreciControl Anemia |
| Traceability | Reference method is Folate III (Application on the E2010) | Reference method is the Elecsys Folate II assay |
| Reagent Stability | Unopened - Same<br>Opened - Same<br>On analyzers - 2 weeks | Unopened 2-8℃ - up to expiration<br>Opened 2-8℃ - 8 weeks<br>On Elecsys 2010 and cobas e411- 2 weeks |
| Measuring Range | 120 ng/mL - 620 ng/mL | 46.5 - 620 ng/mL |
| Analytical Sensitivity at Lower Limits | LoB ≤ 20 ng/mL<br>LoD ≤ 46.5 ng/mL<br>LoQ ≤ 120.0 ng/mL | LoB ≤ 19.84 ng/mL<br>LoD ≤ 46.5 ng/mL<br>LoQ ≤ 62.0 ng/mL |
| RBC CalSet and the Folate RBC CalCheck) | | |
| Dilution | Samples with folate concentrations above<br>the measuring range can be diluted<br>manually with Folate RBC Hemolyzing<br>Reagent (ascorbic acid solution, 0.2%).<br>The recommended dilution is 1:2. The<br>concentration of the diluted sample must<br>be >265 ng/mL. After manual dilution,<br>multiply the results by the dilution factor<br>2. | Samples with folate concentrations<br>above the measuring range can be<br>manually diluted with 0.2% ascorbic<br>acid solution. The recommended<br>dilution is 1:2. The concentration of the<br>diluted sample must be > 310 ng/mL.<br>Multiply the result by the dilution factor. |
| Precision | Elecsys 2010/cobas e411 Repeatability Hemolysate 2, mean 155 ng/mL:<br>SD 7.73 ng/mL; CV 5.0% Hemolysate 3, mean 272 ng/mL:<br>SD 11.2 ng/mL; CV 4.1% Hemolysate 4, mean 527 ng/mL:<br>SD 17.1 ng/mL; CV 3.3% | Elecsys 2010/cobas e411 Repeatability Sample 1, mean 229 ng/mL: SD 12.2<br>ng/mL; CV 5.3% Sample 2, mean 350 ng/mL: SD 17.0<br>ng/mL; CV 4.9% Sample 3, mean 481 ng/mL: SD 25.7<br>ng/mL; CV 5.3% |
| | Elecsys Modular E170/cobas e 601/602<br>Repeatability Hemolysate 2, mean 191 ng/mL:<br>SD 11.5 ng/mL; CV 6.0% Hemolysate 3, mean 258 ng/mL:<br>SD 14.1 ng/mL; CV 5.5% Hemolysate 4, mean 580 ng/mL:<br>SD 12.8 ng/mL; CV 2.2% | |
| | Elecsys 2010/cobas e411 Intermediate<br>Precision Hemolysate 2, mean 155 ng/mL:<br>SD 12.2 ng/mL; CV 7.9% Hemolysate 3, mean 272 ng/mL:<br>SD 16.9 ng/mL; CV 6.2% Hemolysate 4, mean 527 ng/mL:<br>SD 24.8 ng/mL; CV 4.7% | Elecsys 2010/cobas e411 Intermediate<br>Precision Sample 1, mean 229 ng/mL: SD 16.1<br>ng/mL; CV 7.0% Sample 2, mean 350 ng/mL: SD 25.2<br>ng/mL; CV 7.2% Sample 3, mean 481 ng/mL: SD 34.6<br>ng/mL; CV 7.2% |
| | Elecsys Modular E170/cobas e 601/602<br>Intermediate Precision Hemolysate 2, mean 191 ng/mL:<br>SD 12.5 ng/mL; CV 6.5% Hemolysate 3, mean 258 ng/mL:<br>SD 15.1 ng/mL; CV 5.9% Hemolysate 4, mean 580 ng/mL:<br>SD 19.7 ng/mL; CV 3.4% | |
| Analytical<br>Specificity | Same | The following cross-reactivities were<br>found:<br>Aminopterin 2.7%<br>Folinic acid 2.3%<br>Amethopterin 2.3% |
| | RBC CalSet and the Folate RBC CalCheck) | |
| Interferences | Same<br>Also includes the following<br>precautionary statement for high<br>protein samples:<br>Samples with extremely high<br>total protein concentrations (e.g.<br>patients suffering from<br>Waldenstrom's<br>macroglobulinemia) are not<br>suitable for use in this assay,<br>since they may lead to the<br>formation of protein gel in the<br>assay cup. Processing protein gel<br>may cause a run abort. The<br>critical protein concentration is<br>dependent upon the individual<br>sample composition and the<br>sample type. | The assay is unaffected by icterus<br>(bilirubin < 564 µmol/L or < 33 mg/dL),<br>lipemia (Intralipid < 1500 mg/dL), and<br>biotin < 86.1 nmol/L or <21 ng/mL,<br>IgG < 16 g/L and IgA < 4.0 g/L.<br><i>Criterion: Recovery within ± 10% of initial value<br/>with samples >5 ng/mL and < +/- 0.5 ng/mL<br/>with samples ≤ 5 ng/mL.</i> In patients receiving therapy with high<br>biotin doses (i.e. >5 mg/day), no sample<br>should be taken until at least 8 hours<br>after the last biotin administration. No interference was observed from<br>rheumatoid factors up to a concentration<br>of 1000 IU/mL. In vitro tests were performed on 18<br>commonly used pharmaceuticals and in<br>addition on human erythropoietin. No<br>interference with the assay was found. It is contraindicated to measure samples<br>of patients receiving therapy with certain<br>pharmaceuticals, e.g. methotrexate or<br>leucovorin, because of the cross-<br>reactivity of folate binding protein with<br>these compounds. In rare cases, interference due to<br>extremely high titers of antibodies to<br>streptavidin and ruthenium can occur. |
| Expected Values | Whole Blood Folate (from<br>hemolysate sample)<br>Expected = 209-640 (2.5th - 97.5th<br>percentile)<br><br>RBC Folate (folate in<br>erythrocyte fraction)<br>Expected = 499-1504 ng/mL (2.5th - 97.5th percentile) | American Journal of Clinical Nutrition<br>Expected = 4.6 - 34.8 ng/mL<br>(all ages & male/female) |
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Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate
RBC CalSet and the Folate RBC CalCheck)
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.
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Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate
RBC CalSet and the Folate RBC CalCheck)
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Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate RBC CalSet and the Folate RBC CalCheck)
| (2) Elecsys Folate RBC CalSet | | |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Elecsys Folate RBC CalSet | Predicate<br>Elecsys Folate III CalSet<br>(K082340) |
| Intended Use | Elecsys Folate RBC CalSet is<br>used for calibrating the<br>quantitative Elecsys Folate<br>RBC assay on the Elecsys and<br>cobas e immunoassay analyzers. | Elecsys Folate III CalSet is used<br>for calibrating the quantitative<br>Elecsys Folate III assay on the<br>Elecsys and cobas e immunoassay<br>analyzers. |
| Levels | Same | Two |
| Matrix | Hemolysate based master<br>calibrators and human serum<br>product calibrators | Human serum |
| Format | Same | Lyophilized |
| Stability | Same | Unopened: up to the stated<br>expiration date<br>After reconstituting:<br>At 2-8C - 3 days<br>At -20C - 3 months (freeze only<br>once)<br>Onboard: use only once |
| Composition | Same | Buffer: HEPES 50mM<br>Preservative: Bronidox L 0.5% |
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Elecsys Folate RBC Test System (including Folate RBC Assay (Rack Pack), the Folate RBC CalSet and the Folate RBC CalCheck)
| (3) Elecsys Folate RBC CalCheck | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Elecsys Folate RBC CalCheck | Predicate<br>Elecsys Folate III CalCheck<br>(K082340) |
| Intended Use | Elecsys Folate RBC CalCheck<br>is used in the verification of the<br>calibration established by the<br>Elecsys Folate RBC assay on<br>the Elecsys and cobas e<br>immunoassay analyzers. | Elecsys Folate III CalCheck is<br>used for verification of the<br>calibration established by the<br>Elecsys Folate III reagent on the<br>Elecsys and cobas e immunoassay<br>analyzers. |
| Levels | Same | Three |
| Matrix | Hemolysate | Human serum |
| Format | Same | Lyophilized |
| Stability | Same | Unopened and stored at 2 - 8 C:<br>up to the stated expiration date<br>After reconstituting: 4 hours at<br>20-25C |
| Composition | Same | Buffer: HEPES 50mM<br><br>Preservative: Bronidox L 0.5% |
End of Document
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle or other national bird. The bird is depicted with flowing lines, giving it a sense of movement and freedom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
## HAY 1 2 2011
Roche Diagnostics C/O Ms. Kathie Goodwin 9115 Hague Rd. PO Box 50416 Indianapolis, IN 46250
Re: k103716
Trade/Device Name: Roche Elecsys Folate RBC, Folate RBC CalCheck, Folate RBC CalSet Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN, JJX, JIT Dated: April 8, 2011 Received: April 12, 2011
Dear Ms. Goodwin:
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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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 Small Manufacturers, International and Consumer Assistance at its toll from mober (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
:
Enclosure
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# Indications for Use Form
510(k) Number (if known):
Device Name:
(1) Elecsys Folate RBC Assay (2) Elecsys Folate RBC CalSet (3) Elecsys Folate RBC CalCheck
Indications for Use:
(1) Elecsys Folate RBC Assay: Measurements obtained by this device are used in the diagnosis and treatment of anemias on the Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.
(2) Elecsys Folate RBC CalSet: Elecsys Folate RBC CalSet is used for calibrating the Elecsys Folate RBC assay on the Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.
(3) Elecsys Folate RBC CalCheck: Elecsys Folate RBC CalCheck is used for the verification of the calibration established by the Elecsys Folate RBC reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.
Prescription Use × (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)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103716
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