(142 days)
(1) Elecsys 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. Measurements obtained by this assay are used in the diagnosis and treatment of anemias.
(2) Elecsys 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.
(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.
(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.
The provided text describes the Elecsys Folate RBC Test System, but it is a device for in vitro quantitative determination of folate in red blood cells and not an AI or imaging device. Therefore, many of the requested categories related to AI performance, such as MRMC studies, ground truth establishment by experts for image data, or training/test set sample sizes for AI models, are not applicable.
However, I can extract information related to the device's analytical performance and the studies conducted to demonstrate its substantial equivalence to a predicate device, focusing on the available information.
Here's the breakdown based on the provided text, adapted for a non-AI diagnostic device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a table format. Instead, the submission demonstrates substantial equivalence by comparing the performance characteristics of the new Elecsys Folate RBC Assay to the predicate device (Elecsys RBC Folate III Assay) in a feature-by-feature comparison. The reported performance of the new device is shown alongside the predicate's performance. The "acceptance criteria" here are implicitly the predicate device's performance, as the goal is to show substantial equivalence.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Elecsys Folate RBC Assay) |
|---|---|---|
| Measuring Range | 46.5 - 620 ng/mL | 120 ng/mL - 620 ng/mL |
| Analytical Sensitivity (LoB) | ≤ 19.84 ng/mL | ≤ 20 ng/mL |
| Analytical Sensitivity (LoD) | ≤ 46.5 ng/mL | ≤ 46.5 ng/mL |
| Analytical Sensitivity (LoQ) | ≤ 62.0 ng/mL | ≤ 120.0 ng/mL |
| Dilution (Min. diluted conc.) | The concentration of the diluted sample must be > 310 ng/mL. | The concentration of the diluted sample must be >265 ng/mL. |
| Precision (Repeatability, Elecsys 2010/cobas e411, Sample 1/Hemolysate 2) | Mean 229 ng/mL: SD 12.2 ng/mL; CV 5.3% | Hemolysate 2, mean 155 ng/mL: SD 7.73 ng/mL; CV 5.0% |
| Precision (Repeatability, Elecsys 2010/cobas e411, Sample 2/Hemolysate 3) | Mean 350 ng/mL: SD 17.0 ng/mL; CV 4.9% | Hemolysate 3, mean 272 ng/mL: SD 11.2 ng/mL; CV 4.1% |
| Precision (Repeatability, Elecsys 2010/cobas e411, Sample 3/Hemolysate 4) | Mean 481 ng/mL: SD 25.7 ng/mL; CV 5.3% | Hemolysate 4, mean 527 ng/mL: SD 17.1 ng/mL; CV 3.3% |
| Precision (Repeatability, Elecsys Modular E170/cobas e 601/602, Hemolysate 2) | Not applicable (predicate not tested on these platforms) | Hemolysate 2, mean 191 ng/mL: SD 11.5 ng/mL; CV 6.0% |
| Precision (Repeatability, Elecsys Modular E170/cobas e 601/602, Hemolysate 3) | Not applicable | Hemolysate 3, mean 258 ng/mL: SD 14.1 ng/mL; CV 5.5% |
| Precision (Repeatability, Elecsys Modular E170/cobas e 601/602, Hemolysate 4) | Not applicable | Hemolysate 4, mean 580 ng/mL: SD 12.8 ng/mL; CV 2.2% |
| Precision (Intermediate Precision, Elecsys 2010/cobas e411, Sample 1/Hemolysate 2) | Mean 229 ng/mL: SD 16.1 ng/mL; CV 7.0% | Hemolysate 2, mean 155 ng/mL: SD 12.2 ng/mL; CV 7.9% |
| Precision (Intermediate Precision, Elecsys 2010/cobas e411, Sample 2/Hemolysate 3) | Mean 350 ng/mL: SD 25.2 ng/mL; CV 7.2% | Hemolysate 3, mean 272 ng/mL: SD 16.9 ng/mL; CV 6.2% |
| Precision (Intermediate Precision, Elecsys 2010/cobas e411, Sample 3/Hemolysate 4) | Mean 481 ng/mL: SD 34.6 ng/mL; CV 7.2% | Hemolysate 4, mean 527 ng/mL: SD 24.8 ng/mL; CV 4.7% |
| Precision (Intermediate Precision, Elecsys Modular E170/cobas e 601/602, Hemolysate 2) | Not applicable | Hemolysate 2, mean 191 ng/mL: SD 12.5 ng/mL; CV 6.5% |
| Precision (Intermediate Precision, Elecsys Modular E170/cobas e 601/602, Hemolysate 3) | Not applicable | Hemolysate 3, mean 258 ng/mL: SD 15.1 ng/mL; CV 5.9% |
| Precision (Intermediate Precision, Elecsys Modular E170/cobas e 601/602, Hemolysate 4) | Not applicable | Hemolysate 4, mean 580 ng/mL: SD 19.7 ng/mL; CV 3.4% |
| Analytical Specificity / Cross-Reactivity | Aminopterin 2.7%, Folinic acid 2.3%, Amethopterin 2.3% | Same (Implies similar or acceptable cross-reactivities, though specific percentages are not re-listed for the new device) |
| Interferences | Unaffected by icterus, lipemia, biotin (up to 86.1 nmol/L or 21 ng/mL), IgG, IgA. No interference from rheumatoid factors up to 1000 IU/mL. No interference from 18 common pharmaceuticals or human erythropoietin. | Similar interference study reported ("Same") with an added precautionary statement for high protein samples causing protein gel. Specific interference limits are not re-listed but implied to be similar or improved. |
| Expected Values (Whole Blood Folate) | American Journal of Clinical Nutrition Expected = 4.6 - 34.8 ng/mL (all ages & male/female) | Expected = 209-640 (2.5th - 97.5th percentile) (from hemolysate sample) |
| Expected Values (RBC Folate) | Not separately specified for predicate in this section | Expected = 499-1504 ng/mL (2.5th - 97.5th percentile) (folate in erythrocyte fraction) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device, the Elecsys RBC Folate III Test System (K082340). This type of study demonstrates that the new device is as safe and effective as the predicate device by showing that it has similar technological characteristics and performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a single "test set" sample size in the way an AI model validation might. Instead, it details various analytical performance studies with different "samples" for each attribute:
- Precision (Repeatability & Intermediate Precision): Tested on multiple "Hemolysate" or "Sample" controls at different concentration levels. For each level, measurements were taken to determine SD and CV. The exact number of replicates or runs is not specified in the summary but is typically substantial for precision studies (e.g., multiple runs over several days).
- Analytical Sensitivity (LoB, LoD, LoQ): Determined using analytical methods, likely involving dilutions of folate-containing samples. The specific sample count for these determinations is not provided.
- Interferences: Tested using various interfering substances and pharmaceuticals. The number of samples/donors tested for each interference is not specified, but typically involves spiking known concentrations into samples and assessing recovery.
- Expected Values: Determined from a "Whole Blood Folate (from hemolysate sample)" study and an "RBC Folate (folate in erythrocyte fraction)" study. The sample size for these population studies is not provided in the summary.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. For in vitro diagnostic device submissions, such data is typically generated in a controlled laboratory setting (prospective) and may involve samples from different geographical regions, but this is not specified here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI/imaging device where expert consensus is used to establish ground truth for a test set. This device quantifies a biomarker (folate in RBCs). The "ground truth" for its analytical performance is established through reference methods and internal validation procedures, not human interpretation or adjudication by experts.
4. Adjudication Method for the Test Set
Not applicable. As this device measures a quantitative biomarker, there is no "adjudication" in the sense of resolving discrepancies in human interpretation or labeling. Analytical performance is typically verified against established laboratory standards and reference methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device used for interpretation or diagnosis by human readers, so an MRMC study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device performance study. The Elecsys Folate RBC Test System performs the quantitative measurement of folate in RBCs automatically on immunoassay analyzers (Elecsys and cobas e platforms) without human-in-the-loop interpretative performance. The performance metrics (measuring range, sensitivity, precision, interference) are all measures of the algorithm and system's analytical capability.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on analytical reference methods and established laboratory principles. For example:
- For analytical sensitivity (LoB, LoD, LoQ): Determined using standard statistical methods and known concentrations of analyte.
- For precision: Assessed by running replicate measurements on control samples.
- For accuracy/comparison to predicate: The predicate device itself (Elecsys RBC Folate III Assay) serves as the "reference" for demonstrating substantial equivalence. The traceability of the new device is stated as "Reference method is Folate III (Application on the E2010)", meaning its measurements are compared to the predicate's measurements. The predicate's traceability is to the "Elecsys Folate II assay."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The system's underlying principles are based on known biochemistry (competitive binding assay using folate binding protein) and not data-driven learning from a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of in vitro diagnostic device.
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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• After 1 month when using same reagent lot• After 7 days when using same reagent kit on the analyzer• 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 - SameOpened - SameOn analyzers - 2 weeks | Unopened 2-8℃ - up to expirationOpened 2-8℃ - 8 weeksOn 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/mLLoD ≤ 46.5 ng/mLLoQ ≤ 120.0 ng/mL | LoB ≤ 19.84 ng/mLLoD ≤ 46.5 ng/mLLoQ ≤ 62.0 ng/mL |
| RBC CalSet and the Folate RBC CalCheck) | ||
| Dilution | Samples with folate concentrations abovethe measuring range can be dilutedmanually with Folate RBC HemolyzingReagent (ascorbic acid solution, 0.2%).The recommended dilution is 1:2. Theconcentration of the diluted sample mustbe >265 ng/mL. After manual dilution,multiply the results by the dilution factor2. | Samples with folate concentrationsabove the measuring range can bemanually diluted with 0.2% ascorbicacid solution. The recommendeddilution is 1:2. The concentration of thediluted sample must be > 310 ng/mL.Multiply the result by the dilution factor. |
| Precision | Elecsys 2010/cobas e411 Repeatability Hemolysate 2, mean 155 ng/mL:SD 7.73 ng/mL; CV 5.0% Hemolysate 3, mean 272 ng/mL:SD 11.2 ng/mL; CV 4.1% Hemolysate 4, mean 527 ng/mL:SD 17.1 ng/mL; CV 3.3% | Elecsys 2010/cobas e411 Repeatability Sample 1, mean 229 ng/mL: SD 12.2ng/mL; CV 5.3% Sample 2, mean 350 ng/mL: SD 17.0ng/mL; CV 4.9% Sample 3, mean 481 ng/mL: SD 25.7ng/mL; CV 5.3% |
| Elecsys Modular E170/cobas e 601/602Repeatability Hemolysate 2, mean 191 ng/mL:SD 11.5 ng/mL; CV 6.0% Hemolysate 3, mean 258 ng/mL:SD 14.1 ng/mL; CV 5.5% Hemolysate 4, mean 580 ng/mL:SD 12.8 ng/mL; CV 2.2% | ||
| Elecsys 2010/cobas e411 IntermediatePrecision Hemolysate 2, mean 155 ng/mL:SD 12.2 ng/mL; CV 7.9% Hemolysate 3, mean 272 ng/mL:SD 16.9 ng/mL; CV 6.2% Hemolysate 4, mean 527 ng/mL:SD 24.8 ng/mL; CV 4.7% | Elecsys 2010/cobas e411 IntermediatePrecision Sample 1, mean 229 ng/mL: SD 16.1ng/mL; CV 7.0% Sample 2, mean 350 ng/mL: SD 25.2ng/mL; CV 7.2% Sample 3, mean 481 ng/mL: SD 34.6ng/mL; CV 7.2% | |
| Elecsys Modular E170/cobas e 601/602Intermediate Precision Hemolysate 2, mean 191 ng/mL:SD 12.5 ng/mL; CV 6.5% Hemolysate 3, mean 258 ng/mL:SD 15.1 ng/mL; CV 5.9% Hemolysate 4, mean 580 ng/mL:SD 19.7 ng/mL; CV 3.4% | ||
| AnalyticalSpecificity | Same | The following cross-reactivities werefound:Aminopterin 2.7%Folinic acid 2.3%Amethopterin 2.3% |
| RBC CalSet and the Folate RBC CalCheck) | ||
| Interferences | SameAlso includes the followingprecautionary statement for highprotein samples:Samples with extremely hightotal protein concentrations (e.g.patients suffering fromWaldenstrom'smacroglobulinemia) are notsuitable for use in this assay,since they may lead to theformation of protein gel in theassay cup. Processing protein gelmay cause a run abort. Thecritical protein concentration isdependent upon the individualsample composition and thesample type. | The assay is unaffected by icterus(bilirubin < 564 µmol/L or < 33 mg/dL),lipemia (Intralipid < 1500 mg/dL), andbiotin < 86.1 nmol/L or <21 ng/mL,IgG < 16 g/L and IgA < 4.0 g/L.Criterion: Recovery within ± 10% of initial valuewith samples >5 ng/mL and < +/- 0.5 ng/mLwith samples ≤ 5 ng/mL. In patients receiving therapy with highbiotin doses (i.e. >5 mg/day), no sampleshould be taken until at least 8 hoursafter the last biotin administration. No interference was observed fromrheumatoid factors up to a concentrationof 1000 IU/mL. In vitro tests were performed on 18commonly used pharmaceuticals and inaddition on human erythropoietin. Nointerference with the assay was found. It is contraindicated to measure samplesof patients receiving therapy with certainpharmaceuticals, e.g. methotrexate orleucovorin, because of the cross-reactivity of folate binding protein withthese compounds. In rare cases, interference due toextremely high titers of antibodies tostreptavidin and ruthenium can occur. |
| Expected Values | Whole Blood Folate (fromhemolysate sample)Expected = 209-640 (2.5th - 97.5thpercentile)RBC Folate (folate inerythrocyte fraction)Expected = 499-1504 ng/mL (2.5th - 97.5th percentile) | American Journal of Clinical NutritionExpected = 4.6 - 34.8 ng/mL(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 | PredicateElecsys Folate III CalSet(K082340) |
| Intended Use | Elecsys Folate RBC CalSet isused for calibrating thequantitative Elecsys FolateRBC assay on the Elecsys andcobas e immunoassay analyzers. | Elecsys Folate III CalSet is usedfor calibrating the quantitativeElecsys Folate III assay on theElecsys and cobas e immunoassayanalyzers. |
| Levels | Same | Two |
| Matrix | Hemolysate based mastercalibrators and human serumproduct calibrators | Human serum |
| Format | Same | Lyophilized |
| Stability | Same | Unopened: up to the statedexpiration dateAfter reconstituting:At 2-8C - 3 daysAt -20C - 3 months (freeze onlyonce)Onboard: use only once |
| Composition | Same | Buffer: HEPES 50mMPreservative: Bronidox L 0.5% |
:
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)
| (3) Elecsys Folate RBC CalCheck | ||
|---|---|---|
| Feature | Elecsys Folate RBC CalCheck | PredicateElecsys Folate III CalCheck(K082340) |
| Intended Use | Elecsys Folate RBC CalCheckis used in the verification of thecalibration established by theElecsys Folate RBC assay onthe Elecsys and cobas eimmunoassay analyzers. | Elecsys Folate III CalCheck isused for verification of thecalibration established by theElecsys Folate III reagent on theElecsys and cobas e immunoassayanalyzers. |
| Levels | Same | Three |
| Matrix | Hemolysate | Human serum |
| Format | Same | Lyophilized |
| Stability | Same | Unopened and stored at 2 - 8 C:up to the stated expiration dateAfter reconstituting: 4 hours at20-25C |
| Composition | Same | Buffer: HEPES 50mMPreservative: 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
Page 1 of 1
§ 862.1295 Folic acid test system.
(a)
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.(b)
Classification. Class II.