(121 days)
(1) Elecsys Anti-CCP immunoassay: Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Anti-CCP immunoassay is a two step IgG-capture test principle immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The Elecsys Anti-CCP reagent kit consists of a Reagent Pack (R1, R2 and M[streptavidin-coated microparticles]) and lyophilized calibrators 1 and 2.
(2) The Elecsys PreciControl Anti-CCP is a lyophilized product consisting of human serum with added Anti-CCP antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels.
Note: The reagent is packaged with calibrators; controls are packaged separately.
Here's a summary of the acceptance criteria and study findings for the Elecsys Anti-CCP Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys Anti-CCP Immunoassay are implicitly defined by its performance in comparison to the predicate device, the Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit (K052133). The goal is to demonstrate "substantial equivalence."
| Feature/Acceptance Criteria Category | Elecsys Anti-CCP Assay Performance | Predicate Device Performance (Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit) |
|---|---|---|
| Precision | Elecsys 2010 and cobas e 411:Total CV:3.1% CV @ 16.9 U/mL4.5% CV @ 356 U/mL3.0% CV @ 24.6 U/mL2.5% CV @ 137 U/mLWithin-run CV:0.6% CV @ 16.9 U/mL2.3% CV @ 356 U/mL1.0% CV @ 24.6 U/mL1.4% CV @ 137 U/mL | Intra-assay Precision:12.8%CV @ 1007.4 U/mL6.5% CV @ 240.1 U/mL7.0%CV @ 95.7 U/mL8.4% CV @ 51.7 U/mL8.1% CV @ 33.6 U/mL4.3% CV @ 88.1 U/mLInter-assay Precision:11.7% CV @ 1105.9 U/mL7.9% CV @ 257.4 U/mL6.0% CV @ 93.1 U/mL7.8% CV @ 52.5 U/mL14.5% CV @ 33.3 U/mL17.7% CV @ 94.9 U/mL |
| LoQ (Functional Sensitivity) | 8 U/mL | N/A (Not given for predicate) |
| LoB (Limit of Blank) | ≤ 7 U/mL | N/A (Not given for predicate) |
| LoD (Limit of Detection / Analytical Sensitivity) | ≤ 8 U/mL | N/A (Not given for predicate, but LDL is 1.6 U/mL) |
| LDL (Lower Detection Limit) | N/A (Not given for Elecsys) | 1.6 U/mL |
| Measuring Range | 8 – 1000 U/mL (defined by the limit of detection and the maximum of the master curve) | 1.6 – 1600 U/mL |
| Method Comparison (Agreement vs. Predicate) | Positive Percent Agreement = 94.3% (95% CI = 91.7 – 96.2)Negative Percent Agreement = 98.4% (95% CI = 97.5 – 99.1)Total Percent Agreement = 97.3% (95% CI = 96.3 – 98.0) | Predicate compared to alternative ELISA:Positive Percent Agreement = 99.3% (95% CI = 93.2 – 100%)Negative Percent Agreement = 96.7% (95% CI = 81.6 – 99.9%)Overall Percent Agreement = 97.8% (95% CI = 93.2 – 100%) |
| Interference (Bilirubin) | Unaffected by: < 25 mg/dL | Unaffected by: ≤ 0.2 mg/mL |
| Interference (Hemoglobin) | Unaffected by: < 0.5 g/dL | Unaffected by: ≤ 400 mg/dL |
| Interference (Intralipid/Lipid) | Unaffected by: < 1500 mg/dL | Unaffected by: ≤ 15 mg/mL |
| Interference (Biotin) | Unaffected by: < 30 ng/mL | N/A (Not given for predicate) |
| Interference (Rheumatoid factor) | Interference observed above 150 IU/mL | Unaffected by: ≤ 200 IU/mL |
| Hook Effect | No high-dose hook effect at anti-CCP concentrations up to 7000 U/mL | Not given. |
Study that proves the device meets the acceptance criteria:
A "Method Comparison" study was conducted to demonstrate substantial equivalence between the Elecsys Anti-CCP Immunoassay and the predicate device.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 1606 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The predicate device's comparison mentions "320 frozen retrospective sera" with 175 from RA patients and 145 normals from a blood bank, suggesting the Elecsys study likely used a retrospective collection as well, but this is not explicitly stated for the Elecsys study itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for the test set. Instead, the performance of the Elecsys Anti-CCP Immunoassay was compared directly to the results obtained from the predicate device (IMMUNOSCAN RA Anti-CCP test kit). Therefore, the predicate device's results served as the reference for comparison, not a ground truth established by independent experts for the purpose of validating the new device.
4. Adjudication method for the test set
Not applicable. The study compares the new device directly against a predicate device, rather than against an adjudicated ground truth from experts.
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 an immunoassay device, not an imaging device requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study describes the standalone performance of the Elecsys Anti-CCP Immunoassay. It's an automated immunoassay where the result is generated directly by the instrument, without a human "in-the-loop" making interpretive decisions of the assay output. The method comparison data (positive, negative, and total percent agreement) directly reflects this standalone performance against the predicate device.
7. The type of ground truth used
For the method comparison study, the "ground truth" was established by the results of the predicate device, the Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit. This is an indirect form of ground truth, relying on the established performance of an already marketed device.
8. The sample size for the training set
The document does not provide information on a specific "training set" for the Elecsys Anti-CCP Immunoassay. As an immunoassay, the calibration curve and master curve are provided with the reagent and generated on each instrument, respectively, rather than a "training set" in the machine learning sense. The assay is "standardized against a commercially available anti-CCP assay."
9. How the ground truth for the training set was established
Not applicable, as a "training set" in the context of algorithm development with an established ground truth is not explicitly mentioned for this immunoassay in the provided text. The assay itself relies on its inherent chemical and detection principles, calibrated against reference materials.
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| 510(k) Summary | K081338 | SEP 11 2008 |
|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | |
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250 | |
| Contact person: Stephanie Greeman• Phone: (317) 521-2458• FAX: (317) 521-2324• email: stephanie.greeman@roche.com | ||
| Secondary contact :Kay Taylor• Phone: (317) 521-3544• FAX: (317) 521-2324• email: kay.taylor@roche.com | ||
| Date Prepared: May 9, 2008 | ||
| Device Name | Proprietary name: (1) Elecsys Anti-CCP Immunoassay(2) Elecsys PreciControl CCP | |
| Common name: (1) Anti-CCP Assay(2) PreciControl Anti-CCP | ||
| Classification name: (1) Antibodies, Anti-Cyclic Citrullinated Peptide(2) Single (specified) analyte controls (Assayed andUnassayed) | ||
| DeviceDescription | (1) The Elecsys Anti-CCP immunoassay is a two step IgG-capture testprinciple immunoassay with streptavidin-coated microparticles andelectrochemiluminescence detection. Results are determined using acalibration curve that is generated specifically on each instrument by a 2 pointcalibration and a master curve provided with the reagent bar code.The Elecsys Anti-CCP reagent kit consists of a Reagent Pack (R1, R2 and M[streptavidin-coated microparticles]) and lyophilized calibrators 1 and 2. | |
| (2) The Elecsys PreciControl Anti-CCP is a lyophilized product consisting ofhuman serum with added Anti-CCP antibody (human) in two concentrationranges. During manufacture, the antibody is spiked into the matrix at thedesired concentration levels. | ||
| Note: The reagent is packaged with calibrators; controls are packagedseparately. | ||
| Intended use /Indications forUse | (1) Elecsys Anti-CCP immunoassay: Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinatedpeptides in human serum and plasma. The results of the assay are intended tobe used as an aid in the diagnosis of rheumatoid arthritis in combination withother clinical and laboratory findings.The electrochemiluminescence immunoassay "ECLIA" is intended for use onElecsys and cobas e immunoassay analyzers. | |
| (2) Elecsys PreciControl Anti-CCP is used for quality control of the ElecsysAnti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers. | ||
| Substantialequivalence | The Elecsys Anti-CCP Test System is substantially equivalent to otherdevices legally marketed in the United States. | |
| (1) Elecsys Anti-CCP Immunoassay is equivalent to the EurodiagnosticaIMMUNOSCAN RA Anti-CCP Test Kit (K052133). Both products areintended for use in the semi-quantitative determination of human IgGantibodies to cyclic citrullinated peptides in human serum. | ||
| (2) Elecsys PreciControl Anti-CCP is equivalent to the controls contained inthe Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit (K052133). | ||
| Continued on next page | ||
| Substantialequivalence -comparison | The following table compares the Elecsys Anti-CCP Immunoassay with thepredicate device. | |
| Immunoassay Comparison | ||
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Intended Use /Indication forUse | Immunoassay for the in vitro semi-quantitative determination of humanIgG autoantibodies to cycliccitrullinated peptides in humanserum and plasma. The results ofthe assay are intended to be used asan aid in the diagnosis ofrheumatoid arthritis in combinationwith other clinical and laboratoryfindings.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on Elecsys and cobas eimmunoassay analyzers. | The Immunoscan RA anti-CCP test kitis an enzyme-linked immunosorbentassay (ELISA) for detection and semi-quantitation of IgG antibodies toCyclic Citrullinated Peptides (CCP) inhuman sera. The assay is used todetect antibodies in a single serumspecimen. The results of the assay areto be used as an aid to the diagnosis ofRheumatoid Arthritis (RA), inconjunction with other laboratory andclinical findings. The analysis shouldbe performed by trained laboratoryprofessionals. |
| Assay Protocol | IgG-capture test principle | ELISA - IgG adsorption |
| DetectionProtocol | electrochemiluminescenceimmunoassay (ECLIA) | photometric |
| Traceability/Standardization | Standardized against acommercially available anti-CCPassay | Not given |
| CalibrationInterval | • After 1 month (28 days) whenusing the same reagent lot• After 7 days (when using thesame reagent kit on the analyzer)• As required: e.g. quality controlfindings outside the specifiedlimits | Calibrate with each test |
| Sample Type | Human serum and plasma | Human serum |
:
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:
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The following table compares the Elecsys Anti-CCP Immunoassay with the Substantial equivalence predicate device.
comparison
| Immunoassay Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Reagent Stability | • Unopened up to the statedexpiration date stored at 2 – 8°C• On all analyzers:• 1 week or• maximum of 40 hours on theanalyzer; up to 4 weekswhen stored alternately inthe refrigerator and on theanalyzer. | Store kit at 2 – 8°C in a dark place upto stated expiration date. |
| Calibrator | Anti-CCP calibrators 1 and 2supplied with kit | Five levels of calibrators supplied withkit |
| Controls | Elecsys PreciControl Anti-CCP 1and 2 | Reference, positive, and negativecontrols supplied with kit |
| Expected Values | Positive: ≥ 17 U/mL | Negative: < 25 U/mLPositive: ≥ 25 U/mL |
| Instrument | Elecsys 2010, MODULARANALYTICS E170, cobas e 411,cobas e 601 | spectrophotometer |
| MeasuringRange | 8 – 1000 U/mL (defined by the limitof detection and the maximum ofthe master curve) | 1.6 – 1600 U/mL |
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The following table compares the performance of Elecsys Anti-CCP Substantial Immunoassay with the predicate device.
equivalence comparison
| Immunoassay Performance Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Precision | Elecsys 2010 and cobas e 411:Total3.1% CV @ 16.9 U/mL4.5% CV @ 356 U/mL3.0% CV @ 24.6 U/mL2.5% CV @ 137 U/mLWithin-run0.6% CV @ 16.9 U/mL2.3% CV @ 356 U/mL1.0% CV @ 24.6 U/mL1.4% CV @ 137 U/mL | Intra-assay Precision:12.8%CV @ 1007.4 U/mL6.5% CV @ 240.1 U/mL7.0%CV @ 95.7 U/mL8.4% CV @ 51.7 U/mL8.1% CV @ 33.6 U/mL4.3% CV @ 88.1 U/mLInter-assay Precision:11.7% CV @ 1105.9 U/mL7.9% CV @ 257.4 U/mL6.0% CV @ 93.1 U/mL7.8% CV @ 52.5 U/mL14.5% CV @ 33.3 U/mL17.7% CV @ 94.9 U/mL |
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The following table compares the performance of Elecsys Anti-CCP Substantial equivalence -Immunoassay with the predicate device. comparison
| Immunoassay Performance Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) | ||
| LoQ (FunctionalSensitivity) | 8 U/mL | N/A |
| Limit of Blank(LoB) | ≤ 7 U/mL | N/A |
| Limit ofDetection LoD(AnalyticalSensitivity) | ≤ 8 U/mL | N/A |
| LDL (LowerDetection Limit) | N/A | 1.6 U/mL |
| Limitations | The assay is unaffected by:Bilirubin: < 25 mg/dL Hemoglobin: < 0.5 g/dL Intralipid: < 1500 mg/dL Biotin: < 30 ng/mLIn patients receiving therapy with high biotin doses (i.e. >5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. Interference was observed from Rheumatoid factor above concentrations of 150 IU/mL. | The assay is unaffected by:Bilirubin: ≤ 0.2 mg/mL Hemoglobin: ≤ 400 mg/dL Lipid: ≤ 15 mg/mL Rheumatoid factor: ≤ 200 IU/mL |
| Substantial | The following table compares the performance of Elecsys Anti-CCP | |
| equivalence - | Immunoassay with the predicate device. | |
| comparison | ||
| Immunoassay Performance Comparison, continued | ||
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Limitations,continued | Interference with pathologic levels of unspecific IgG can not be excluded. However, the coincidence of RA and gammopathy in one patient has been reported to be very low. The anti-CCP test results can be false negative in patients with hypergammaglobulinaemia. Results from patients suffering from this disorder should not be used for diagnostic purposes. In vitro tests were performed on 18 commonly used pharmaceuticals and in addition on methrotrexate and prednisolone. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. |
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l
ce -
The following table compares the performance of Elecsys Anti-CCP
Immunoassay with the predicate device.
{7}------------------------------------------------
| Substantial | The following table compares the performance of Elecsys Anti-CCP |
|---|---|
| equivalence - | Immunoassay with the predicate device. |
| comparison |
| Immunoassay Performance Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) | ||
| Limitations, continued | The risk of interference from potential immunological interactions between test components and rare sera has been minimized by the inclusion of suitable additives. In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. The test contains additives which minimize these effects. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. |
:
Continued on next page
:
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| Substantialequivalence -comparison | The following table compares the performance of Elecsys Anti-CCPImmunoassay with the predicate device. |
|---|---|
| -------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
| Immunoassay Performance Comparison, continued | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) | ||||||||||||||||||||||||||||||||||||||||||
| MethodComparison | Elecsys Anti-CCP was comparedanti-CCP microtiter plate ELISAassay (IMMUNOSCAN RA Anti-CCP test kit).1606 samples tested using a cut-offof ≥ 17 U/mL for the Elecsys Anti-CCP assay.N=1606 ImmunoscanAnti-CCP + - Total ElecsysAnti-CCP + 428 18 446 - 26 1134 1160 total 454 1152 1606Positive Percent Agreement = 94.3%(95% CI = 91.7 – 96.2)Negative Percent Agreement = 98.4%(95% CI = 97.5 – 99.1)Total Percent Agreement = 97.3%(95% CI = 96.3 – 98.0) | Percent agreement of the ImmunoscanRA CCP kit compared to an alternativeCCP ELISA:A total of 320 frozen retrospective serawere assayed. 175 samples were fromRA patients and 145 samples werenormals from a blood bank. Thefollowing table summarizes the results.Alternative ELISA Positive Negative Total Immuno-scanRACCPKit Positive 135 6 141 Negative 1 178 179 Total 136 184 320Positive Percent Agreement = 99.3%(95% CI = 93.2 – 100%)Negative Percent Agreement = 96.7%(95% CI = 81.6 – 99.9%)Overall Percent Agreement = 97.8%(95% CI = 93.2 – 100%)The 95% confidence interval (CI) wascalculated using the exact method. | ||||||||||||||||||||||||||||||||||||||||||
| Hook Effect | No high-dose hook effect at anti-CCP concentrations up to 7000U/mL | Not given. |
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The following table compares the calibrators supplied with the Elecsys Anti-Substantial CCP immunoassay kit with the calibrators supplied with the predicate equivalence comparison device.
| Calibrator Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Levels | 2 | 5 |
| Format | Lyophilized | Liquid |
| Matrix | human serum | same |
| AnalyteConcentration(Anti-CCPantibodies;human) | Calibrator 1: 20 U/mLCalibrator 2: 200 U/mL | Calibrator A: 1600 U/mLCalibrator B: 800 U/mLCalibrator C: 200 U/mLCalibrator D: 50 U/mLCalibrator E: 25 U/mL |
| Stability | Unopened:• Until expiration date.Reconstituted:• On the analyzers at 20 – 25°C:up to 2 hours• At -20°C: up to 4 weeks (freezeonly once).• After thawing: use only once. | N/A |
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The following table compares the calibrators supplied with the Elecsys Anti-Substantial equivalence -CCP immunoassay kit with the calibrators supplied with the predicate comparison device.
| Calibrator Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Handling | Dissolve carefully the contents ofone bottle by adding exactly 1.0 mLof distilled water and allow to standclosed for 15 minutes toreconstitute. Mix carefully,avoiding the formation of foam.Transfer the reconstituted calibratorinto the empty labeled snap-capbottles supplied (CalSet Vials).Attach the supplied labels to theadditional bottles. Store thealiquots immediately at -20°C.Perform only one calibrationprocedure per aliquot. Allinformation required for correctoperation is read in via therespective reagent barcode. | N/A |
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The following table compares the Elecsys PreciControl Anti-CCP with the Substantial controls supplied with the predicate device. equivalence comparison
| Control Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Anti-CCP | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Intended Use | Used for quality control of theElecsys Anti-CCP immunoassay onthe Elecsys and cobas eimmunoassay analyzers. | N/A |
| Levels | Two | 3 |
| Format | Lyophilized | Liquid |
| Matrix | Human serum | same |
| Stability | Unopened:• Store at 2 – 8°C until expirationdate.Reconstituted:• On the analyzers at 20 – 25°C: upto 5 hours• At -20°C: up to 1 month (freezeonly once).• After thawing: use only once. | N/A |
| AnalyteConcentrationControl 1 | 20 U/mL Anti-CCP antibodies(human) | Negative Control(actual concentration not given) |
| AnalyteConcentrationControl 2 | 100 U/mL Anti-CCP antibodies(human) | Positive Control(actual concentration not given) |
| AnalyteConcentrationControl 3 | N/A | Reference Control(actual concentration not given) |
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The following table compares the Elccsys PreciControl Anti-CCP with the Substantial equivalence controls supplied with the predicate device. comparison
| Control Comparison, continued | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Anti-CCP | Predicate DeviceEurodiagnostica IMMUNOSCANRA Anti-CCP Test Kit (K052133) |
| Handling | Dissolve carefully the contents ofone bottle by adding exactly 2.0 mLof distilled water and allow to standclosed for 15 minutes to reconstitute.Mix carefully, avoiding theformation of foam.Transfer aliquots of freshlyreconstituted controls intoappropriate tubes for storage. Storethe aliquots immediately at -20°C.When measuring a non-barcodedcontrol, use only recommendedsample tubes, cup on tube or cup onrack. Perform only one controlprocedure per aliquot. | N/A |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2008
Roche Diagnostics c/o Ms. Stephanie Greeman Regulatory Affairs Consultant US Regulatory Submissions 9115 Ilague Road Indianapolis, IN 46250
Re: K081338
Trade/Device Name: Elecsys Anti-CCP Immunoassay and Elecsys PreciControl Anti-CCP Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX, JJX Dated: July 31, 2008 Received: August 4, 2008
Dear Ms. Greeman:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); 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
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Page 2 –
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,
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 (240) 276-0450. 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Elecsys Anti-CCP Test System
Confidential
Indication for Use – Elecsys Anti-CCP Immunoassay
510(k) Number (if known): K081338
Device Name: Elecsys Anti-CCP Immunoassay
Indication For Use:
Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Maria M Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081338
{16}------------------------------------------------
Elecsys Anti-CCP Test System
Confidential
Indication for Use - Elecsys PreciControl Anti-CCP
K081338 510(k) Number (if known):
Device Name: Elecsys PreciControl Anti-CCP
Indication For Use:
Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Nova M Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081338
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).