(196 days)
(1) Elecsys Anti-TSHR immunoassay: Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Anti-TSHR immunoassay is a three step competition 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.
(2) The Elecsys PreciControl ThyroAB is a lyophilized product consisting of human serum with added Anti-TSHR antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels.
Note: The reagent and quality control material are packaged separately.
The provided document describes the Elecsys Anti-TSHR Immunoassay and its substantial equivalence to a predicate device, the BRAHMS LUMItest TRAK human Assay (K033454). The document does not clearly define explicit "acceptance criteria" in a typical clinical study sense with predetermined thresholds for sensitivity, specificity, accuracy, or other performance metrics the device must meet. Instead, it focuses on demonstrating comparable performance to a legally marketed predicate device.
The study presented is primarily a method comparison study and a precision study.
Here's an analysis of the requested information based on the provided text:
1. Table of "Acceptance Criteria" and Reported Device Performance
As mentioned, there are no explicitly stated "acceptance criteria" with numerical thresholds that the device must meet in this document. Instead, the focus is on demonstrating "substantial equivalence" through comparable performance to the predicate device. Therefore, the table below will present the performance of the Elecsys Anti-TSHR Immunoassay alongside the claimed comparable performance of the predicate device. The implied "acceptance criteria" are that the new device's performance should be similar to or better than the predicate.
| Feature | Implied "Acceptance Value" (Predicate) | Elecsys Anti-TSHR Assay Performance (Reported) |
|---|---|---|
| Precision (Within-run) | Interassay: 4.1 – 35.1% CV (samples 0.6 – 20.3 IU/L) | Elecsys 2010 and cobas e 411:5.9% CV @ 1.73 IU/L4.4% CV @ 2.57 IU/L2.7% CV @ 6.57 IU/L1.3% CV @ 25.5 IU/L3.0% CV @ 3.60 IU/L1.7% CV @ 15.0 IU/LE170 and cobas e 601:7.6% CV @ 1.71 IU/L5.1% CV @ 2.16 IU/L1.9% CV @ 5.92 IU/L0.9% CV @ 24.6 IU/L3.1% CV @ 3.16 IU/L1.4% CV @ 14.6 IU/L |
| Precision (Total) | Intra-assay: 2.3 – 24.2% CV (samples 0.9 – 101.7 IU/L) | Elecsys 2010 and cobas e 411:9.7% CV @ 1.73 IU/L6.7% CV @ 2.57 IU/L3.9% CV @ 6.57 IU/L1.8% CV @ 25.5 IU/L5.1% CV @ 3.60 IU/L2.4% CV @ 15.0 IU/LE170 and cobas e 601:11.4% CV @ 1.71 IU/L8.7% CV @ 2.16 IU/L3.8% CV @ 5.92 IU/L1.9% CV @ 24.6 IU/L5.5% CV @ 3.16 IU/L2.4% CV @ 14.6 IU/L |
| Measuring Range | 0.9 – 40 IU/L | 0.8 – 40 IU/L |
| LoQ (Limit of Quantitation) | 0.9 IU/L | 0.9 IU/L |
| LoB (Limit of Blank) | 0.4 IU/L | ≤0.5 IU/L |
| LoD (Limit of Detection) | NA | ≤0.8 IU/L |
| Analytical Specificity (Interference) | Anti-TG < 2000 U/mLAnti-TPO < 3000 U/mLTSH < 1000 mU/LLH < 9000 U/LFSH < 15,000 U/L | No interference with:Anti-TG if less than 4000 IU/mLAnti-TPO if less than 600 IU/mLHuman TSH if less than 1000 mIU/LHuman LH if less than 10,000 mIU/LHuman FSH if less than 10,000 mIU/LhCG if less than 50,000 mIU/mL |
| Method Comparison (Concordance) | Overall agreement 75.0% (between KRONUS TRAb and LUMItest TRAK) | Elecsys vs. BRAHMS LUMItest TRAK human:Number of samples: 212Negative Agreement: 102/109 = 93.6% (95% CI: 87.2 to 97.4)Positive Agreement: 199/199 = 100% (95% CI: 98.2 to 100)Note: 42 indeterminate results from comparative method were excluded from concordance calculations, with further analysis provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: 212 clinical samples.
- Precision (Internal Studies): The number of samples for precision evaluation is not explicitly stated but implied to be sufficient for calculating CVs at various concentrations.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "clinical samples" but doesn't specify if they are retrospective or prospective, or their geographical source.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Experts: Not applicable in the traditional sense for this type of IVD (In Vitro Diagnostic) device. The "ground truth" or reference for the method comparison study is obtained by comparing the Elecsys Anti-TSHR Immunoassay results against the predicate device (BRAHMS LUMItest TRAK human Assay). The predicate device itself acts as the "reference method" in this context.
- Qualifications: Not applicable, as expert review of samples to establish ground truth is not described.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The method comparison directly compares the quantitative output of the investigational device to the predicate device. There is no mention of human expert adjudication to resolve discrepancies between the devices.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for quantitative determination of TSH receptor autoantibodies, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, the performance metrics (precision, measuring range, LoQ, LoB, LoD, analytical specificity, and method comparison) presented are for the Elecsys Anti-TSHR Immunoassay operating as an automated, standalone diagnostic system. There is no human interpretation component integrated into the assay's performance claims. The "human-in-the-loop" equivalent for such an assay would be the medical professional interpreting the quantitative results in the context of a patient's clinical picture, which is outside the scope of the device's standalone analytical performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the method comparison, the "ground truth" is established by the predicate device's measurements (BRAHMS LUMItest TRAK human Assay). The document explicitly states "A comparison of the Elecsys Anti-TSHR assay (y) with BRAHMS LUMItest TRAK human (x) using clinical samples gave the following correlations." This indicates a direct comparison to an already cleared and accepted method, rather than a separate gold standard like pathology or long-term outcomes data for determining TSHR autoantibody levels.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not provided or applicable in the context of this document. This submission describes an immunoassay based on a competition principle with streptavidin-coated microparticles and electrochemiluminescence detection. It's a biochemical assay, not a machine learning or AI algorithm that typically requires a distinct training set. The reported data pertains to the validation of the finalized assay.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As it's an immunoassay technology, there isn't a "training set" in the machine learning sense. The assay development would involve optimizing reagents, protocols, and calibration, which are internal to the assay's design and not typically referred to as "training" with a distinct "ground truth" dataset in this context.
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Kosoog2
| 510(k) Summary | 'JUL 2 8 2008 |
|---|---|
| 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 Diagnostics9115 Hague RoadIndianapolis, IN 46250Contact person: Stephanie GreemanPhone: (317) 521-2458FAX: (317) 521-2324email: stephanie.greeman@roche.com• Secondary contact :Kay Taylor• Phone: (317) 521-3544• FAX: (317) 521-2324• email: kay.taylor@roche.comDate Prepared: June 17, 2008 |
| Device Name | Proprietary name: (1) Elecsys Anti-TSHR Immunoassay(2) Elecsys PreciControl ThyroABCommon name: (1) Anti-TSHR Assay(2) PreciControl ThyroABClassification name: (1) System, Test, Thyroid Autoantibody(2) Single (specified) analyte controls (Assayed and Unassayed) |
| DeviceDescription | (1) The Elecsys Anti-TSHR immunoassay is a three step competitionprinciple 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.(2) The Elecsys PreciControl ThyroAB is a lyophilized product consisting ofhuman serum with added Anti-TSHR antibody (human) in two concentrationranges. During manufacture, the antibody is spiked into the matrix at thedesired concentration levels.Note: The reagent and quality control material are packaged separately. |
| Intended use /Indications forUse | (1) Elecsys Anti-TSHR immunoassay: Immunoassay for the in vitroquantitative determination of autoantibodies to TSH receptor in human serumusing a human thyroid stimulating monoclonal antibody. The anti-TSHreceptor determination is used in the assessment of patients with suspectGraves' disease (autoimmune hyperthyroidism).The electrochemiluminescence immunoassay "ECLIA" is intended for use onElecsys and cobas e immunoassay analyzers.(2) Elecsys PreciControl ThyroAB is used for quality control of the ElecsysAnti-TSHR immunoassay on the Elecsys and cobas e immunoassayanalyzers. |
| Substantialequivalence | The Elecsys Anti-TSHR Test System is substantially equivalent to thefollowing cleared device:(1) Elecsys Anti-TSHR Immunoassay is equivalent to the BRAHMSLUMItest TRAK human Assay (K033454). Both products are intended foruse in the quantitative determination of autoantibodies to TSH receptor inhuman serum.(2) Elecsys PreciControl ThyroAB is equivalent to the controls contained inthe BRAHMS LUMItest TRAK human Assay Kit (K033454). |
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The following table compares the Elecsys Anti-TSHR Immunoassay with the Substantial predicate device. equivalence comparison
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK humanAssay (K033454) |
| Intended Use | Immunoassay for the in vitroquantitative determination ofautoantibodies to TSH receptor inhuman serum using a human thyroidstimulating monoclonal antibody.The anti-TSH receptordetermination is used in theassessment of patients with suspectGraves' disease (autoimmunehyperthyroidism).The electrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on Elecsys and cobas eimmunoassay analyzers. | Luminescence receptor assay (LRA)for the quantitative determination ofantibodies to the human thyrotropin(TSH) receptor. |
| Indication forUse | See intended use. | The measurement of TSH receptorautoantibodies is used in theassessment of patients with suspectGraves' disease (autoimmunehyperthyroidism). |
| Assay Protocol | Competition principle | same |
| DetectionProtocol | electrochemiluminescenceimmunoassay (ECLIA) | Luminescence receptor assay (LRA) |
| Traceability/Standardization | Standardized against NIBSC 1st IS90/672 Standard | WHO 1st International referencematerial, 90/672 for TSAb |
| CalibrationInterval | • Daily• As required: e.g. quality controlfindings outside the specifiedlimits | N/A |
| Sample Type | Human serum | same |
| Immunoassay Comparison, continued | ||
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK humanAssay (K033454) |
| Reagent Stability | Unopened up to the statedexpiration date stored at 2 – 8°C• On the analyzer: 72 hours ifcontinuously stored onboard; or 2weeks including up to 56 hours intotal onboard if stored alternatelyin the refrigerator and on theanalyzer | N/A |
| Calibrator | Anti-TSHR calibrators 1 and 2supplied with kit | TRAK standards supplied with kit |
| Controls | Elecsys PreciControl ThyroAB | TRAC controls I and II supplied withkit |
| Pretreatment | Pretreatment 1: buffer solutionPretreatment 2: empty bottle forpretreatment reagent (PTR)reconstituted with pretreatmentbuffer (PTB)PTR: pretreatment reagentPTB: pretreatment buffer | Buffer for incubation of samplesBuffer for reconstitution of tracerTracer: luminescence-labeled b-TSH |
| Expected Values | Positive: > 1.75 IU/L | Negative: < 1 IU/LEquivocal: 1 – 2 IU/LPositive: > 2 IU/L |
| Instrument | Elecsys 2010, MODULARANALYTICS E170, cobas e 411,cobas e 601 | Luminometer |
| MeasuringRange | 0.8 – 40 IU/L (defined by the limitof detection and the maximum ofthe master curve) | 0.9 – 40 IU/L |
| Feature | Immunoassay Performance ComparisonElecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK humanAssay (K033454) |
| Precision | Elecsys 2010 and cobas e 411:Within-run5.9% CV @ 1.73 IU/L4.4% CV @ 2.57 IU/L2.7% CV @ 6.57 IU/L1.3% CV @ 25.5 IU/L3.0% CV @ 3.60 IU/L1.7% CV @ 15.0 IU/LTotal9.7% CV @ 1.73 IU/L6.7% CV @ 2.57 IU/L3.9% CV @ 6.57 IU/L1.8% CV @ 25.5 IU/L5.1% CV @ 3.60 IU/L2.4% CV @ 15.0 IU/LE170 and cobas e 601:Within-run7.6% CV @ 1.71 IU/L5.1% CV @ 2.16 IU/L1.9% CV @ 5.92 IU/L0.9% CV @ 24.6 IU/L3.1% CV @ 3.16 IU/L1.4% CV @ 14.6 IU/LTotal11.4% CV @ 1.71 IU/L8.7% CV @ 2.16 IU/L3.8% CV @ 5.92 IU/L1.9% CV @ 24.6 IU/L5.5% CV @ 3.16 IU/L2.4% CV @ 14.6 IU/L | Interassay Precision:Sample means 0.6 IU/L – 20.3 IU/L =%CV 4.1 – 35.1%Intra-assay Precision:Sample means 0.9 IU/L – 101.7 IU/L =% CV 2.3 – 24.2% |
のお気になる。
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The following table compares the Elecsys Anti-TSHR Immunoassay with the Substantial equivalence predicate device. comparison
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The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence comparison
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The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence -
comparison
| Immunoassay Performance Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK human Assay (K033454) |
| LoQ | 0.9 IU/L | 0.9 IU/L |
| Limit of Blank(LoB) | ≤0.5 IU/L | 0.4 IU/L |
| Limit of Detection LoD(Analytical Sensitivity) | ≤0.8 IU/L | NA |
| Analytical Specificity | No interference with:Anti-TG if less than 4000 IU/mL Anti-TPO if less than 600 IU/mL Human TSH if less than 1000 mIU/L Human LH if less than 10,000 mIU/mL Human FSH if less than 10,000 mIU/mL hCG if less than 50,000 mIU/mL | No interference with :Anti-TG if less than 2000 U/mL Anti-TPO if less than 3000 U/mL Human TSH if less than 1000 mU/L Human LH if less than 9000 U/L Human FSH if less than 15,000 U/L |
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The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence comparison
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK human Assay (K033454) |
|---|---|---|
| Limitations | The assay is unaffected by:Bilirubin: < 25 mg/dL Hemoglobin: < 0.4 g/dL Intralipid: < 1500 mg/dL Biotin: < 10 ng/mL Elevated results are obtained when using samples with biotin concentrations > 10 ng/mL In 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. No interference was observed from rheumatoid factors up to a concentration of 600 IU/mL | Hemoglobin:Concentrations: Not givenRecovery: 100 – 125% Bilirubin:Concentrations: 0.625, 1.25, 2.5, 5, 10, 20 mg/dLRecovery: 91 – 100% Lipids:Concentration: dilutions prepared off of 634 mg/dL lipemic serumRecovery: 76 – 100% |
| Substantialequivalence –comparison | The following table compares the performance of Elecsys Anti-TSHRImmunoassay with the predicate device. | |
| Immunoassay Performance Comparison, continued | ||
| Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK humanAssay (K033454) | |
| Limitations, continued | In vitro tests were performed on 20 commonly used pharmaceuticals. No interference with the assay was found except for heparin. In samples containing heparin elevated results are obtained. 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. For diagnostic purposes, the results should always be assessed in conjunction with the patients medical history, clinical examination and other findings. |
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The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence comparison
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK humanAssay (K033454) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MethodComparison | A comparison of the Elecsys Anti-TSHRassay (y) with BRAHMS LUMItest TRAKhuman (x) using clinical samples gave thefollowing correlations:Number of samples measured: 212Sample concentrations were between 1.1IU/L and 40.0 IU/LPassing/Bablok: 95% CI:$y = 1.183x - 0.316$ $Slope = 1.11 - 1.27$$Intercept = -0.633 to -0.079$Concordance:Commercial anti-TSHR Elecsys Anti-TSHR <1.0 IU/L 1.0 - 2.0a IU/L >2.0 IU/L >1.75 IU/L 7 11 199 ≤1.75 IU/L 102 31 0 total 109 42 199 a. 42 results were excluded from thecalculations after giving indeterminate resultson the comparative method. A moredifferentiated analysis of the samples whichgave indeterminate results in the comparativemethod shows that: 2 of the 11 samplespositive with Elecsys Anti-TSHR have valuesfrom 1.75 – 2 IU/L, 9 of the 11 samplespositive with Elecsys Anti-TSHR have valuesabove 2 IU/L, 11 of the 31 samples negativewith Elecsys Anti-TSHR have values below 1IU/L and 20 of the 31 samples negative withElecsys Anti-TSHR have values from 1 – 1.75IU/L. | A correlation study was performedbetween the predicate KRONUSTRAb assay and the LUMItest TRAKassay. Fifty-two (52) serum samplesobtained from either confirmedGraves' disease patients or patientswith non-Graves' thyroid disease weretested in parallel. Overall agreementbetween the two assays was 75.0%. | ||||||||||||||||||||
| AgreementClassification %Agreement(%)b 95%CI (%) Neg.Agreement 102/109 93.6% 87.2 to97.4 Pos.Agreement 199/199 100% 98.2 to100 b. % positive of Elecsys Anti-TSHR amongindeterminate results of comparative methodequals 26.2% (11/42). % negative of ElecsysAnti-TSHR among indeterminate results ofcomparative method equals 73.8% (31/42). |
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The following table compares the calibrators supplied with the Elecsys Anti-Substantial equivalence -TSHR immunoassay kit with the calibrators supplied with the predicate comparison device.
| Calibrator Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK human Assay (K033454) |
| Levels | 2 | 6 |
| Format | Lyophilized | N/A |
| Matrix | human serum | same |
| AnalyteConcentration(Anti-TSHRantibody;human) | Calibrator 1: 1.0 IU/LCalibrator 2: 25 IU/L | Calibrator 1: 0 IU/LCalibrator 2: 1 IU/LCalibrator 3: 2 IU/LCalibrator 4: 4 IU/LCalibrator 5: 16 IU/LCalibrator 6: 40 IU/L |
| Stability | Unopened:• Store at 2 – 8°C until expiration date.Reconstituted:• On the analyzers at 20 – 25°C: up to 3 hours• At -20°C: up to 3 months (freeze only once.• After thawing: use only once. | N/A |
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The following table compares the calibrators supplied with the Elecsys Anti-Substantial TSHR immunoassay kit with the calibrators supplied with the predicate equivalence comparison device.
| Calibrator Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate DeviceBRAHMS LUMItest TRAK humanAssay (K033454) |
| Handling | Dissolve contents of one bottle byadding exactly 2.0 mL of distilledwater and allow to stand closed for15 minutes to reconstitute. Mixcarefully, avoiding the formation offoam.Transfer aliquots of freshlyreconstituted controls into emptylabeled snap-cap bottles. Attach thesupplied labels to the additionalbottles. Store the aliquotsimmediately at -20°C. Performonly one calibration procedure peraliquot | N/A |
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The following table compares the Elecsys PreciControl ThyroAB with the Substantial predicate device. equivalence comparison
| Control Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl ThyroAB | Predicate DeviceBRAHMS LUMItest TRAKhuman Assay (K033454) |
| Intended Use | Used for quality control of theElecsys Anti-TSHR immunoassayon the Elecsys and cobas eimmunoassay analyzers. | N/A |
| Levels | Two | same |
| Format | Lyophilized | N/A |
| Matrix | Human serum | same |
| Stability | Unopened:• Store at 2 – 8°C until expirationdate.Reconstituted:• On the analyzers at 20 – 25°C: upto 3 hours• At -20°C: up to 3 months (freezeonly once.• After thawing: use only once. | N/A |
| AnalyteConcentrationPC 1 | 4 IU/L Anti-TSHR antibody (human) | Negative, indeterminate(actual concentration not given) |
| AnalyteConcentrationPC 2 | 16 IU/L Anti-TSHR antibody(human) | Positive(actual concentration not given) |
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The following table compares the Elecsys PreciControl ThyroAB with the Substantial predicate device. equivalence comparison
| Control Comparison, continued | ||
|---|---|---|
| Characteristic | Elecsys PreciControl ThyroAB | Predicate DeviceBRAHMS LUMItest TRAK human Assay (K033454) |
| Handling | Dissolve contents of one bottle byadding exactly 2.0 mL of distilledwater and allow to stand closed for15 minutes to reconstitute. Mixcarefully, avoiding the formation offoam.Transfer aliquots of freshlyreconstituted controls into emptylabeled snap-cap bottles. Attach thesupplied labels to the additionalbottles. Store the aliquotsimmediately at -20°C. Perform onlyone control procedure 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 and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Ms. Stephanie Greeman Regulatory Affairs Consultant 9115 Hague Road Box 50416 Indianapolis, IN 46250-0416
JUL 2 8 2008
Re: K080092
Trade/Device Name: Elecsys Anti-HSHR Immunoassay Elecsys PreciControl ThyroAB Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO, JJX Dated: June 17, 2008 Reccived: June 19, 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 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); 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
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Page 2 -
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" (21CFR 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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Indication for Use – Elecsys Anti-TSHR Immunoassay
K 080092 510(k) Number (if known):
Device Name: Elecsys Anti-TSHR Immunoassay
Indication For Use:
Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).
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 (OIVD)
Maria M Elon
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kof 0092
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Indication for Use - Elecsys PreciControl ThyroAB
510(k) Number (if known):
): K080092
Device Name: Elecsys PreciControl ThyroAB
Indication For Use:
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR 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)
Mana m Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080092
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).