(474 days)
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The device consists of two reagents: R1 buffer (Tris buffer pH 7.2, polyethylene glycol 6000) and R2 (goat anti-IgG antiserum). The reagents contain sodium azide as preservative.
When a sample is mixed with R1 buffer and R2 antiserum solution, human IqG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates. Immune complexes formed in solution scatter light in proportion to their size, shape, and concentration. Turbidimeters then measure the reduction of incidence light due to reflection, absorption, or scatter. The decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is a result of complexes formed during the antigen-antibody reaction.
The Beckman Coulter Immunoglobulin G (IgG) reagent for quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers, device K221114, underwent various non-clinical (bench) studies to demonstrate substantial equivalence to its predicate device (K162208).
Here is a summary of the acceptance criteria and reported device performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Sample Type | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|---|
| Method Comparison | Serum | Slope: Not explicitly stated, but R-value of 0.9981 suggests strong correlation. | Slope: 1.015, Intercept: -25.422, R: 0.9981 | Pass |
| CSF | Slope: Not explicitly stated, but R-value of 0.9995 suggests strong correlation. | Slope: 0.998, Intercept: 0.1141, R: 0.9995 | Pass | |
| Linearity/Reportable Range | Serum | Linear Range: 75-3,000 mg/dL Allowable Difference: ±8% between 375-3,000 mg/dL; ±30 mg/dL between 75-375 mg/dL | Linear From: 73.2868 mg/dL Linear To: 3261.9190 mg/dL | Pass |
| CSF | Linear Range: 2-50 mg/dL Allowable Difference: ±10% between 2-50 mg/dL; ±0.5 mg/dL between 2.0-5 mg/dL | Linear From: 1.9 mg/dL Linear To: 53.0 mg/dL | Pass | |
| Sensitivity (LOQ) | Serum | <75 mg/dL at ≤20%CV | 18.5 mg/dL at 10% CV (LOB: 5.6 mg/dL, LOD: 8.6 mg/dL) | Pass |
| CSF | <2 mg/dL at ≤20%CV | 0.63 mg/dL at 20% CV (LOB: 0.11 mg/dL, LOD: 0.31 mg/dL) | Pass | |
| Precision | Serum & Plasma | Within-run Precision: ≤ 3.5% CV Total Precision: < 6% CV | 20-day Precision (CV): Within Run: 0.9% - 3.4% Within Laboratory: 1.2% - 4.9% 5-day Precision (CV): Within Run: 0.8% - 2.8% Within Laboratory: 1.0% - 3.6% Reproducibility: 1.0% - 3.6% | Pass |
| CSF | Within-run Precision: ≤ 6% CV or ≤0.4 mg/dL Total Precision: < 7.5% CV or <0.5mg/dL | 20-day Precision (CV): Within Run: 1.6% - 4.7% Within Laboratory: 2.6% - 5.6% 5-day Precision (CV): Within Run: 0.9% - 1.7% Within Laboratory: 1.4% - 4.4% Reproducibility: 1.4% - 4.7% | Pass | |
| Interference | Serum | Lipemia: Intralipid (1000 mg/dL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL Icteric: Bilirubin (40 mg/dL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL Hemolysis: Hemolysate (500 mg/dL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL RF: RF (1200 IU/mL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL | All interferences found to be ≤10%, indicating no significant interference (NSI). | Pass |
| CSF | Icteric: Bilirubin (36 mg/dL) interference ≤10% at IgG conc. of 5 mg/dL & 20 mg/dL Hemolysis: Hemolysate (500 mg/dL) interference ≤10% at IgG conc. of 5 mg/dL & 20 mg/dL | All interferences found to be ≤10%, indicating no significant interference (NSI). | Pass | |
| Reference Interval | Serum (Adult) | Agreement with original IgG serum reference interval for candidate DxC 500 AU analyzer. Expected Range: 635 - 1,741 mg/dL | The transference study passed, validating the acceptability of the original reference interval (635 - 1,741 mg/dL). | Pass |
2. Sample sizes for the test set and data provenance:
- Method Comparison:
- Serum: 147 samples
- CSF: 114 samples
- Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. The studies were conducted "using patient correlation studies", suggesting human patient samples were used.
- Linearity/Reportable Range: Each dilution was assayed in quadruplicate on a DxC 500 AU analyzer. High and low pools were prepared and inter-diluted. Number of distinct patient samples used for pooling is not specified.
- Sensitivity (LOB, LOD, LOQ):
- LOB: 72 blank replicates per reagent lot (4 blank native serum samples 'analyte-depleted' run n=6 for 3 days).
- LOD and LOQ: 500 replicates per reagent lot for each application (10 low-level samples for IgG run 10-fold for 5 days).
- Precision:
- 20-day study: Not explicitly stated as a number of distinct samples, but samples were tested over 20 days.
- 5-day study: Not explicitly stated as a number of distinct samples, but samples were tested over 5 days.
- Interference: All test samples were assayed n=5 at two analyte levels. The number of distinct samples for each interferent type is not specified.
- Reference Interval: "Transference approach" used to validate the original IgG serum reference interval. The specific number of samples for the transference study is not detailed.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This device is an in vitro diagnostic (IVD) test for quantitative measurement of immunoglobulins. The "ground truth" in this context is the analytically measured concentration of IgG in samples, determined by laboratory methods. Therefore, expert interpretation or consensus as seen in imaging or clinical diagnosis is not directly applicable. The "ground truth" is established by the analytical method itself, calibrated against known standards, and verified through method comparison with predicate devices and established guidelines.
4. Adjudication method for the test set:
Not applicable in the context of quantitative IVD testing. Analytical results are directly compared to predefined acceptance criteria based on industry guidelines (e.g., CLSI).
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 in vitro diagnostic device, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an analytical reagent system used on automated analyzers. Its performance is inherently "standalone" in the sense that the instrument and reagent determine the quantitative result without human subjective interpretation of the primary measurement. Human involvement lies in sample preparation, loading, and result interpretation, but not in the analytical measurement itself. The studies described are assessing the performance of this standalone analytical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for performance evaluation is based on analytical measurements against established standards and comparison to a legally marketed predicate device. For example:
- Method Comparison: Comparison against the predicate device (Beckman Coulter IgG Reagent on DxC 700 AU analyzer) to demonstrate similar quantitative results.
- Linearity/Sensitivity/Precision: Determined by assessing the device's ability to accurately and reproducibly measure known concentrations or concentrations derived from highly characterized samples.
- Reference Interval: Validation of an existing reference interval for the predicate device, implying that the ground truth for this is derived from previously established clinical studies.
8. The sample size for the training set:
Not applicable. This device is a diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of the reagent and its methods would involve extensive research and development, but this is distinct from "training data" for an AI model.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this IVD device.
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August 2, 2023
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Tracy Jin Senior Analyst, Regulatov Affairs No. 181 West Su Hong Road, Suzhou Industrial Park Suzhou, Jiangsu 215021 People's Republic of China
Re: K221114
Trade/Device Name: Immunoglobulin G (IgG) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E immunological test system Regulatory Class: Class II Product Code: CFN Dated: February 14, 2023 Received: February 16, 2023
Dear Tracy Jin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221114
Device Name Immunoglobulin G (IgG)
Indications for Use (Describe)
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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1.0 Submitted By
Tracy Jin Sr. Regulatory Affairs Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 181 West Su Hong Road, Suzhou Industrial Park, Suzhou, Jiangsu, P.R. China, 215021 Telephone: 86-512- 6895 5129 Fax: 86-512- 6742 1069
2.0 Date of Preparation
Jul 25,2023
3.0 Device Name(s)
| Proprietary Name: | IgG |
|---|---|
| Common Name: | IgG |
| Classification: | Class II |
| Classification Name: | Immunoglobulins A, G, M, D, E Immunological Test System |
| Product Codes: | CFN |
| Regulation Number: | 21 CFR §866.5510 |
4.0 Predicate Device
| Candidate | Predicate | Manufacturer |
|---|---|---|
| IgG Reagent | IgG Reagent (K162208) | Beckman Coulter, Inc. |
5.0 Device Description
The device consists of two reagents: R1 buffer (Tris buffer pH 7.2, polyethylene glycol 6000) and R2 (goat anti-IgG antiserum). The reagents contain sodium azide as preservative.
When a sample is mixed with R1 buffer and R2 antiserum solution, human IqG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates. Immune complexes formed in solution scatter light in proportion to their size, shape, and concentration. Turbidimeters then measure the reduction of incidence light due to reflection, absorption, or scatter. The decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is a result of complexes formed during the antigen-antibody reaction.
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6.0 Indications for Use
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
7.0 Comparison to the Predicate
Table 7.0 shows the similarities and differences between the candidate and predicate devices.
| Feature | Predicate Device:IgG Reagent(DxC 700 AU ClinicalChemistry Analyzer)(K162208) | Candidate Device:IgG Reagent(DxC 500 AU ClinicalChemistry Analyzer) |
|---|---|---|
| Intended Use | System reagent for thequantitative determination of IgGimmunoglobulins in humanserum, plasma, andcerebrospinal fluid on BeckmanCoulter AU analyzers | Same; updatedinstrument familybranding only.System reagent for thequantitative determinationof IgG immunoglobulins inhuman serum, plasma,and cerebrospinal fluid onBeckman Coulter AU/DxCAU analyzers |
| Measurement | Quantitative | Same |
| Instrument Required | AU400/400e/480, AU640/640e/680, AU2700/5400/AU5800 andDxC 700 AU Beckman CoulterAnalyzers. | AU480, AU680, AU5800,DxC 500 AU and DxC700 AU Beckman CoulterAnalyzers. |
| Methodology | Immunoturbidimetric | Same |
| Antibody | Goat anti-IgG | Same |
| Reagent form and storage | Liquid, on-board storage | Same |
| Feature | Predicate Device:IgG Reagent(DxC 700 AU ClinicalChemistry Analyzer)(K162208) | Candidate Device:IgG Reagent(DxC 500 AU ClinicalChemistry Analyzer) |
| Specimen Type | Serum, EDTA or Lithium heparinplasma, and cerebrospinal fluid | Same |
| Calibration | Serum Protein Multi-Calibrator(Cat # ODR3021) | Same |
| Onboard Stability | 90 Days | Same |
| CalibrationStability | Serum &Plasma90 Days | Same |
| CSF2 Days | Same | |
| AnalyticalRange | Serum &Plasma75 - 3000 mg/dL | Same |
| CSF2- 50 mg/dL | Same | |
| Precision | Serum &PlasmaWithin-run Precision:≤ 3.5% CVTotal Precision:< 6% CV | Same |
| CSFWithin-run Precision:≤ 6% CV or ≤0.4 mg/dLTotal Precision:< 7.5% CV or <0.5mg/dL | Same | |
| Sensitivity | Serum &PlasmaLoQ: <75 mg/dL using a withinlaboratory CV of 20% | Same |
| CSFLoQ: <2 mg/dL using a withinlaboratory CV of 20% | Same | |
| Interference | Serum &PlasmaBilirubin: NSI* up to 40 mg/dLHemolysis: NSI up to 500 mg/dLLipemia: NSI up to 1000 mg/dLRF: NSI up to 1200 IU/mL | Same |
| CSFBilirubin: NSI up to 36 mg/dLHemolysis: NSI up to 500 mg/dL | Same |
Table 7.0 - IgG Predicate Device Comparison Table
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*NSI – No significant interference is recovery within 10% of the initial value
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8.0 Comparison testing
Substantial equivalence is demonstrated through non-clinical (bench) studies as shown below. In accordance with FDA's Guidance for Industry and FDA Staff -Replacement Reagent and Instrument Family Policy, CLSI study protocols were used to verify the performance claims stated in the reagent IFU and ensure that the technological differences between the candidate and predicate analyzer models did not adversely affect safety and effectiveness.
- Method Comparison Linearity Sensitivity Reference Interval Interference Precision
9.0 Summary of Performance Data
The data contained in the Premarket Notification supports a finding of substantial equivalence to the measurand test systems already in commercial distribution.
9.1 Method Comparison with Predicate Device
Method comparison and bias estimation experiments were designed using CLSI Guideline EP09C-ED3 "Measurement Procedure Comparison and Bias Estimation Patient Samples; Third Edition". These patient correlation studies Using demonstrate equivalence between Beckman Coulter's IgG assay on the candidate DxC 500 AU analyzer and the predicate DxC 700 AU analyzer. The results summary in Table 9.1. is based on Weighted Deming regression analysis.
| Sample Type | Units | N | Slope | Intercept | R |
|---|---|---|---|---|---|
| Serum | mg/dL | 147 | 1.015 | -25.422 | 0.9981 |
| CSF | mg/dL | 114 | 0.998 | 0.1141 | 0.9995 |
| Table 9.1 IqG Method Comparison Data Summary |
|---|
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Linearity/Reportable Range: 9.2
Analytical range (linearity) studies were designed to meet the requirements of CLSI quideline EP06-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline". High and low pools were prepared and inter-diluted to achieve concentrations spanning the required linear range. Each dilution was assayed in quadruplicate on a DxC 500 AU analyzer. The performance data for the study demonstrates linearity throughout the claimed dynamic range of the IgG candidate assay, as represented in Table 9.2 below.
| Acceptance Criteria | Results | |||||
|---|---|---|---|---|---|---|
| SampleType | LinearRange | AllowableDifference± % | AllowableDifference± units | LinearFrom | LinearTo | Pass/Fail |
| Serum | 75-3,000 | 8% between375-3,000 | 30 mg/dLbetween75 - 375 | 73.2868 | 3261.9190 | Pass |
| CSF | 2-50 | 10% between2-50 | 0.5 mg/dLbetween2.0 - 5 | 1.9 | 53.0 | Pass |
9.3 Sensitivity (Detection Limits):
LOB, LOD and LOQ studies were designed in accordance with CLSI quideline EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Approved Guideline - Second Edition". For the LOB, LOD, and LOQ determinations, the experimental design consisted of replicate measurements on blank and low-level sample pools using 2 lots of reagent across multiple days. A total of 72 blank replicates were generated per reagent lot (4 blank native serum samples 'analyte-depleted' ran n=6 for 3 days) to generate the LOB value that serves as a component of the LOD determination. For the LOD and LOQ determinations, 500 replicates were generated for each reagent lot for each application; this was comprised of 10 low-level samples for IgG which were run 10fold for 5 days. The LOB, LOD, and LOQ sample preparation information, including the matrices of the spiking solutions, are describe in Table 9.3 below
| SampleType | Units | Low End ofMeasuringRange | LOQ Spec | LOB | LOD | LOQ |
|---|---|---|---|---|---|---|
| Serum | mg/dL | 75 | <75 at ≤20%CV | 5.6 | 8.6 | 18.5 at 10% CV |
| CSF | mg/dL | 2 | <2 at ≤20%CV | 0.11 | 0.31 | 0.63 at 20% CV |
Table 9.3 IgG Sensitivity Data Summary
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9.4 Precision:
Repeatability (within-run) and within- laboratory (total) precision studies were performed in accordance with the CLSI guideline EP05-A3 "Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition" using a 20-day study design. A separate 5-day study design was used to evaluate reproducibility using three DxC 500 AU analyzers. The candidate IgG assay met the performance specifications as stated in the IgG reagent IFU. The results are summarized in the Tables 9.4.1 and 9.4.2 below:
| Sample(Units) | SampleLevels | Mean(n=80) | Repeatability(Within Run) | Within Laboratory(Total) | ||
|---|---|---|---|---|---|---|
| Serum(mg/dL) | 1 | 503.99 | 5.8 | 1.2 | 6.3 | 1.2 |
| Serum(mg/dL) | 2 | 1797.53 | 43.1 | 2.4 | 43.2 | 2.4 |
| Serum(mg/dL) | 3 | 2576.22 | 86.9 | 3.4 | 94.9 | 3.7 |
| Serum(mg/dL) | 4 | 88.31 | 1.6 | 1.8 | 4.3 | 4.9 |
| Serum(mg/dL) | 5 | 835.56 | 7.2 | 0.9 | 14.8 | 1.8 |
| CSF(mg/dL) | 1 | 4.14 | 0.2 | 4.7 | 0.2 | 5.6 |
| CSF(mg/dL) | 2 | 11.20 | 0.2 | 2.1 | 0.4 | 3.1 |
| CSF(mg/dL) | 3 | 36.32 | 0.6 | 1.6 | 0.9 | 2.6 |
Table 9.4.1 IqG 20-day Precision Data Summary
Table 9.4.2 IgG 5-Day Precision Data Summary
| Sample(Units) | SampleLevels | Mean(n=75) | Repeatability(Within Run) | WithinLaboratory(Total) | Reproducibility |
|---|---|---|---|---|---|
| 1 | 481.20 | 0.8% CV | 1.0% CV | 1.0% CV | |
| 3.67 SD | 4.63 SD | 4.63 SD | |||
| Serum(mg/dL) | 2 | 1669.57 | 1.5% CV | 1.7% CV | 1.7% |
| 24.45 SD | 29.04 SD | 29.07 SD | |||
| 3 | 2404.48 | 2.8% CV | 3.6 % CV | 3.6 % CV | |
| 66.69 SD | 86.08 SD | 86.08 SD | |||
| 1 | 3.53 | 1.7% CV, | 4.4% CV | 4.7% CV | |
| 0.06 SD | 0.16 SD | 0.16 SD | |||
| CSF(mg/dL) | 2 | 11.31 | 0.9% CV, | 1.9% CV | 1.9% CV |
| 0.10 SD | 0.22 SD | 0.22 SD | |||
| 3 | 37.18 | 0.9% CV. | 1.4% CV | 1.4% CV | |
| 0.33 SD | 0.50 SD | 0.50 SD |
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9.5 Interferences (Analytical Specificity):
Interference studies were designed based on the CLSI Guideline EP07, 3d Edition "Interference Testing in Clinical Chemistry; Approved Guideline". All test samples were assayed n=5 at two analyte levels. The sample pools tested were at different levels of interferents to determine the magnitude of their effect. The data analysis involved calculating the difference in recovery of the samples with and without the potential interfering substances. The results are summarized in Table 9.5 below. The candidate IgG assay met the performance specifications as stated in the IgG reagent IFU.
| Sample | Interference Threshold | ||||
|---|---|---|---|---|---|
| Lipemic(Intralipid)1 | IctericUnconjugated2 | Hemolytic3 | RF | Pass/Fail | |
| Serum | Intralipid(1000 mg/dL)intf. ≤10%at IgG conc. of1000 mg/dL &2000 mg/dL | Bilirubin(40 mg/dL)intf. ≤10%at IgG conc. of1000 mg/dL &2000 mg/dL | Hemolysate(500 mg/dL)intf. ≤10%at IgG conc. of1000 mg/dL &2000 mg/dL | RF(1200 IU/mL)intf. ≤10%at IgG conc. of1000 mg/dL &2000 mg/dL | Pass |
| CSF | N/A | Bilirubin(36 mg/dL)intf. ≤10%at IgG conc. of5 mg/dL & 20mg/dL | Hemolysate(500 mg/dL)intf. ≤10%at IgG conc. of5 mg/dL & 20mg/dL | N/A | Pass |
Table 9.5 IqG Interferences Data Summary
1 Intralipid is a 20% fat emulsion used to emulate extremely turbid samples.
2 Unconjugated bilirubin (porcine source)
3 Lysed human red blood cells
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9.6 Reference Interval
The Reference Interval study utilized a transference approach in accordance with the CLSI guidelines EP028-A3c "Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition". The purpose of the study was to validate the acceptability of the original IgG serum reference interval for use on the candidate DxC 500 AU analyzer. Transference evaluations were not performed for the CSF sample type. The results are summarized in Table 9.6 below.
| Sample Type | Reference Range (mg/dL) | Result |
|---|---|---|
| Serum(Adult) | 635 - 1,741 | Pass |
| CSF | 15 – 20 years: 3.5 mg/dL ± 2.0 mg/dL21 - 40 years: 4.2 mg/dL ± 1.4 mg/dL41 - 60 years: 4.7 mg/dL ± 1.0 mg/dL | N/A* |
Table 9.6 IgG Reference Interval Summary
*Literature reference used
10.0 Conclusion
The IgG Reagent on the DxC 500 AU Clinical Chemistry Analyzer is identical in design and composition as the IgG Reagent on the DxC 700 AU Clinical Chemistry Analyzer cleared under K162208. Method comparison, linearity, sensitivity, reference interval, interference, and precision testing demonstrate that the assay performance is substantially equivalent between the candidate predicate test systems.
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing requlation 21 CFR 807.92.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).