Quantia IgE
Device Facts
| Record ID | K214068 |
|---|---|
| Device Name | Quantia IgE |
| Applicant | Biokit, S.A. |
| Product Code | DGC · Immunology |
| Decision Date | Feb 21, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Quantia IgE is an in vitro diagnostic test for the quantitative determination of human immunoglobulin E (IgE) in serum or plasma by turbidimetric immunoassay on clinical chemistry analyzers.
Device Story
Quantia IgE is an automated latex-enhanced immunoturbidimetric assay for total IgE measurement in human serum or plasma. The device uses polystyrene latex particles coated with mouse anti-human IgE. When mixed with patient samples and reaction buffer, IgE-mediated agglutination occurs; the degree of agglutination is directly proportional to IgE concentration. The device operates on ARCHITECT c Systems in clinical laboratory settings, performed by laboratory technicians. The system measures the decrease in transmitted light caused by aggregates. Healthcare providers use the quantitative output in conjunction with other clinical studies to diagnose IgE-mediated allergies. The device benefits patients by providing an automated, standardized method for IgE quantification to support allergy diagnosis.
Clinical Evidence
Bench testing only. Validation included assessment of analytical performance parameters (LoB, LoD, LoQ, AMI) and correlation studies following the increase in sample volume from 3.5 μL to 10.5 μL. No clinical data presented.
Technological Characteristics
Turbidimetric immunoassay; in vitro diagnostic reagent system. Operates on clinical chemistry analyzers. Modification: sample volume increased to 10.5 μL; includes Sample Probe Smart Wash feature. Analytical parameters updated: LoB, LoD, LoQ, AMI, correlation factor, read times, and sample stability.
Indications for Use
Indicated for the quantitative determination of human immunoglobulin E (IgE) in serum or plasma for the assessment of allergic status in patients.
Regulatory Classification
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.
Predicate Devices
- Quantia IgE (K214068 - original clearance)
Related Devices
- K050493 — QUANTIA IGE · Biokit, S.A. · Aug 16, 2005
Submission Summary (Full Text)
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February 21, 2023
Biokit, S.A. Angels Roma Regulatory Affairs & Design Quality Director Av. Can Montcau. 7 Llica d'Amunt, Barcelona 08186 Spain
Re: K214068
Trade/Device Name: Quantia IgE Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, And E Immunological Test System Regulatory Class: Class II Product Code: DGC Dated: October 28, 2022 Received: October 31, 2022
Dear Angels Roma:
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) K214068
Device Name Quantia IgE
Indications for Use (Describe)
Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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### 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CER 807.92 and the Safe Medical Device Act of 1990.
| Submission Type | K214068 - Special 510(k) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Information | Biokit, S.A.<br>Av. Can Montcau, 7<br>Lliçà d'Amunt, Barcelona 08186<br>Spain |
| Contact Person | Àngels Roma<br>Quality & Regulatory Affairs VP<br>Phone: +34 (938) 609-000<br>Email: aroma@werfen.com |
| Preparation Date | February 11th, 2023 |
| Device Trade Name | Quantia IgE (IgE, Antigen, Antiserum, Control) |
| Regulatory Information | Regulation Number<br>21 CFR 866.5510<br>Regulation Description<br>Immunoglobulins A, G, M, D and E immunological test system<br>Classification<br>Class II<br>Product Code<br>DGC<br>Classification Panel<br>Immunology |
| Predicate Device | K050493<br>Quantia IgE |
| Device Description | The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric. |
| Indications for Use /<br>Intended Use | Automated latex enhanced immunoassay for the<br>quantitative in vitro determination of total<br>immunoglobulin E (IgE) in human serum or plasma<br>(EDTA, heparin, citrate) using the ARCHITECT c<br>Systems. The measurement of total IgE is useful in the |
| | clinical diagnosis of IgE-mediated allergies, if used in<br>conjunction with other clinical studies. |
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Description of the Modification: The sample volume that is used by the assay is changed from 3.5 µL to 10.5 µL. Due to this modification, additional changes have been implemented in the assay parameters: Read times are changed from 26-27 to 24-25, the Sample Probe water SmartWash is added and the lowlinearity is changed from 25.0 to 20.0 IU/mL. The correlation factor in the assay file is changed from 1.0000 to 1.0500. The changes to the Instruction for Use are detailed below.
| Current Insert Summary and Principle<br>(Excerpt) | Updated Insert Summary and Principle<br>(Excerpt)<br>Revisions in italic and highlights |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRINCIPLES OF THE PROCEDURE | PRINCIPLES OF THE PROCEDURE |
| ---- (additional information is added) | For additional information on system and assay<br>technology, refer to the ARCHITECT System<br>Operations Manual, Section 3. |
| REAGENTS | REAGENTS |
| Reagent Kit | Kit Contents |
| ---- (additional information is added) | Volumes (mL) listed in the following table<br>indicate the volume per vial. |
| ---- (additional information is added) | Test per vial set 69 |
| | Indications of Reagent Deterioration<br>Deterioration of the reagents may be indicated<br>when a calibration error occurs or a control<br>value is out of the specified range.<br>Associated test results are invalid, and samples<br>must be retested.<br>Assay recalibration may be necessary.<br>For troubleshooting information, refer to the<br>ARCHITECT System Operations Manual, Section<br>10. |
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| ---- (additional information is added) | INSTRUMENT PROCEDURE | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | The Quantia IgE assay file must be installed on<br>the ARCHITECT c System prior to performing<br>the assay.<br>For detailed information on assay file installation<br>and viewing and editing assay parameters, refer<br>to the ARCHITECT System Operations Manual,<br>Section 2.<br>For information on printing assay parameters,<br>refer to the ARCHITECT System Operations<br>Manual, Section 5.<br>For a detailed description of system procedures,<br>refer to the ARCHITECT System Operations<br>Manual. | | |
| SPECIMEN COLLECTION AND HANDLING | SPECIMEN COLLECTION AND<br>PREPARATION FOR ANALYSIS | | |
| Suitable Specimens | Specimen Types | | |
| <b>Serum:</b> Use fresh serum collected by standard<br>venipucture techniques. Ensure complete clot<br>formation has taken place prior to<br>centrifugation. Centrifuge according to tube | Specimen Types | | |
| manufacturer's instructions to ensure proper<br>separation of serum blood cells. Gel separator<br>tubes were not tested. | *Serum Serum tubes | | |
| Some specimens, especially those from patients<br>receiving anticoagulant or thrombolytic | *Plasma Acceptable anticoagulants are: | | |
| therapy, may take longer to complete their | Sodium EDTA | | |
| clotting processes. Fibrin clots may | Potassium EDTA | | |
| subsequently form in these sera and the clots<br>could cause erroneous test results. | Sodium heparin | | |
| <b>Plasma:</b> Use plasma collected by standard<br>venipuncture techniques. The acceptable<br>anticoagulanants are sodium EDTA, potassium<br>EDTA, sodium heparin, lithium heparin, and<br>citrate. Ensure centrifugation is adequate to<br>remove platelets. Centrifuge according to tube | Lithium heparin | | |
| manufacturer's instructions to ensure proper<br>separation of plasma from bloods cells. Gel | Sodium citrate | | |
| separator tubes were not tested. | * Gel separator tubes were not tested. | | |
| For total sample volume requirements, refer to the<br>ASSAY PARAMETERS sections of this package<br>insert and Section 5 of the ARCHITECT System<br>Operations Manual. | Other specimen types, collection tube types, and<br>anticoagulants have not been verified with this<br>assay.<br>The instrument does not provide the capability to<br>verify specimen types. It is the responsibility of<br>the operator to verify that the correct<br>specimen types are used in the assay. | | |
| Sample Matrix (Serum vs. Plasma)<br>Five sets of 52 paired samples were run. Sodium<br>EDTA plasma, potassium EDTA plasma, sodium | Sample Matrix (Serum vs. Plasma)<br>Forty paired samples were run. Sodium EDTA<br>plasma, potassium EDTA plasma, sodium | | |
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| | Slope | Y - Intercept |
|------------|-----------------------------------|--------------------------------------|
| Na-EDTA | 0.968<br>(95% CI: 0.963 to 0.973) | -1.553<br>(95% CI: -3.068 to -0.007) |
| K-EDTA | 0.982<br>(95% CI: 0.976 to 0.989) | -1.878<br>(95% CI: -3.873 to 0.117) |
| Na-Heparin | 0.978<br>(95% CI: 0.973 to 0.983) | -0.461<br>(95% CI: -1.983 to 1.060) |
| Li-Heparin | 0.978<br>(95% CI: 0.973 to 0.983) | -1.272<br>(95% CI: -2.761 to 0.218) |
| Citrate | 0.963<br>(95% CI: 0.955 to 0.972) | -2.226<br>(95% CI: -4.702 to 0.250) |
sodium citrate plasma paired to serum samples were used. The linear regression statistics are shown below.
| | Slope | Y-Intercept |
|------------|---------------------------------|----------------------------------|
| Na-EDTA | 0.98<br>(95% CI*: 0.97 to 1.00) | -1.08<br>(95% CI: -3.83 to 1.47) |
| K-EDTA | 1.01<br>(95% CI: 0.99 to 1.03) | 0.80<br>(95% CI: -0.77 to 2.19) |
| Na-Heparin | 1.00<br>(95% CI: 0.98 to 1.01) | -1.22<br>(95% CI: -3.19 to 0.69) |
| Li-Heparin | 0.98<br>(95% CI: 0.98 to 1.00) | 1.23<br>(95% CI: -0.47 to 2.19) |
| Na-Citrate | 0.97<br>(95% CI: 0.96 to 0.99) | -0.74<br>(95% CI: -2.39 to 0.91) |
#### Specimen Storage
| Specimen Type | Temperature | Maximum Storage<br>Time | Special Instructions |
|---------------|-------------|-------------------------|------------------------------------------|
| Serum/Plasma | 20 to 25°C | 1 day | Specimens may be stored<br>on the clot. |
| Serum/Plasma | 2 to 8 °C | 2 days | |
| Serum/Plasma | -20°C | 12 days | Remove serum or plasma<br>from the clot. |
If testing will be delaved longer than the maximum 20 to 25°C or 2 to 8°C storage time, remove serum or plasma from the clot and store frozen (-20°C).
Each laboratory may establish a range around -20°C from either the freezer manufacturer's specifications or your laboratory standard operating procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing.
### Specimen Shipping
Package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. Do not exceed the storage limitations listed above.
#### Specimen Storage
| Temperature | Maximum Storage | Bibliographic<br>Reference |
|-------------|-----------------|----------------------------|
| 20 to 25°C | 7 days | 8 |
| 2 to 8°C | 7 days | 8, 9 |
| -20°C | 6 months | 8 |
Guder et al.8 suggest storage of frozen specimens at -20°C for no longer than the time interval cited above. However, limitations of laboratory equipment make it necessary in practice for clinical laboratories to establish a range around -20°C for specimen storage. This temperature range may be established from either the freezer manufacturer's specifications or your laboratory standard operating procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing.
---- (additional information is added)
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| PROCEDURE | PROCEDURE | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Materials Required but not Provided | Materials Required but not Provided | | | | | | |
| ---- (additional information is added) | For information on materials required for<br>operation of the instrument, refer to the<br>ARCHITECT System Operations Manual, Section<br>1.<br>For information on materials required for<br>maintenance procedures, refer to the<br>ARCHITECT System Operations Manual, Section<br>9. | | | | | | |
| ---- (additional information is added) | Quality Control Guidance | | | | | | |
| | Refer to "Basic QC Practices" by James O<br>Westgard, Ph.D. for guidance on laboratory<br>quality control practices. | | | | | | |
| RESULTS | RESULTS | | | | | | |
| Refer to Appendix C of the ARCHITECT System<br>Operations Manual for information on results<br>calculations. | Calculation<br>For additional information on results<br>calculations, refer to the ARCHITECT System<br>Operations Manual, Appendix C. | | | | | | |
| ---- (additional information is added) | Interpretation of Results<br>As with all analyte determinations, the IgE value<br>should be used in conjunction with information<br>available from clinical evaluation and other<br>diagnostic procedures. | | | | | | |
| ---- (additional information is added) | Flags<br>Some results may contain information in the<br>Flags field. For a description of the flags that<br>may appear in this field, refer to the ARCHITECT<br>System Operations Manual, Section 5. | | | | | | |
| ---- (additional information is added) | Reportable Interval<br>Based on representative data for the limit of<br>quantitation (LoQ) and the limit of detection<br>(LoD), the ranges over which results can be<br>reported are provided below according to the<br>definitions from CLSI EP34, 1st ed. | | | | | | |
| Analytical Measuring Interval (AMI)a Units (IU/mL) 20.0 - 1000.0 Extended Measuring Interval (EMI)b 1000.0 - 10 000.0 a AMI: The AMI is determined by the range of<br>values in IU/mL that demonstrated acceptable<br>performance for linearity, imprecision, and | | | | | | | |
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# werfer
### LIMITATIONS OF THE PROCEDURE
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS
sections of this package insert.
No cross-reactivity studies have been conducted with heterophile antibodies.
There is no prozone interference for undiluted samples containing up to 26,000.0 IU/mL of IgE. Sample concentrations higher than 26,000.0 IU/mL have not been tested.
As the limit of quantification of Quantia IgE is 25.0 IU/mL, it is not recommended to use this test for children less than 12 months of age.
### SPECIFIC PERFORMANCE CHARACTERISTICS
---- (additional information is added)
### Linearity
Linearity was assessed according to Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS EP6-A.12 The reportable range of the Quantia IgE assay is 25.0 to 1000.0 IU/mL.
b EMI: The EMI extends from the upper limit of quantitation (ULoQ) to the ULoQ x dilution factor. The value reflects a 1:10 dilution factor. NOTE: The default Low Linearity value of the assay file corresponds to the lower limit of the analytical measuring interval. Samples with an IgE value below the lower limit of the AMI are reported as < 20.0 IU/mL.
### LIMITATIONS OF THE PROCEDURE
Refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. No cross-reactivity studies have been conducted with heterophile antibodies. There is no prozone interference for undiluted samples containing up to 25 470.7 IU/mL of IgE. Sample concentrations higher than 25 470.7 IU/mL have not been tested. As the limit of quantification of Quantia IgE is
20.0 IU/mL, it is not recommended to use this test for children less than 12 months of age.
### SPECIFIC PERFORMANCE CHARACTERISTICS
Representative performance data are provided in this section. Results obtained in individual laboratories mav varv.
### Linearity
A study was performed based on guidance from CLSI EP06 2nd ed. Two high-analyte samples (human serum IgE at approximately 1040.1 and 1018.1 IU/mL) and 2 zero-analyte samples (IgEdepleted serum) were combined at different proportions to make 2 linearity panels that each consisted of samples with concentrations evenly distributed across the intended analytical measuring interval.
The assay demonstrated acceptable linearity across the analytical measuring interval of 20.0 to 1000.0 IU/mL.
### Limit of Quantification (LOQ)
The LOQ of the Quantia IgE assay is 25.0 IU/mL. The LOQ was determined using dilutions of the 100 IU/mL level of the Quantia IgE Calibrator prepared in physiologic saline. The LOQ is defined as the
#### Lower Limits of Measurement
A study was performed based on guidance from CLSI EP17-A2. The limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) values are summarized below. These
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| lowest analyte concentration that can be measured<br>with a within-run CV below 20% and the recovery is<br>within ± 20% of expected value. | representative data support the lower limit of the<br>analytical measuring interval. | | | | | | | | | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | | | | | | | | | | | | | | | | |
| <b>Limit of Detection (LOD)</b><br>The LOD of the Quantia IgE assay is 12.9 IU/mL,<br>calculated by running 30 replicates of saline. LOD is<br>defined as the mean concentration of an analyte-free<br>sample + 2 SD, where SD is the within-run standard<br>deviation. | | | | | | | | | | | | | | | | |
| | IU/mL LoBa 6.2 LoDb 11.6 LoQc 20.0 a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.<br>b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.<br>c The LoQ is defined as the lowest concentration at which a maximum allowable precision of 20 %CV and a maximum allowable bias of 20% were met and was determined from n ≥ 60 replicates of low-analyte level samples and where the assay is linear. | | | | | | | | | | | | | | | |
| Interfering Substances<br>...<br>Rheumatoid factor interference is less than 10% up to 138 IU/mL.<br>For a comprehensive review of interfering substances, refer to the publication by Young et al.13 | Interfering Substances<br>...<br>Potentially Interfering Endogenous Substances<br>A study was performed based on guidance from CLSI EP07-A2. and CLSI EP37, 1st ed. Each substance was tested at 1 analyte level (approximately 90.0 IU/mL). | | | | | | | | | | | | | | | |
| | No Significant Interference (Interference within ± 5%) Potentially Interfering Substance Interferent Level<br>(mg/dL) Bilirubin (conjugated) 40 Bilirubin (unconjugated) 40 Hemoglobin 1000 Lipemia (chyle) 2.4 AU/cm at 660 nm Lipemia (triglyceride) 1500 | | | | | | | | | | | | | | | |
| | Potentially Interfering Other Substances<br>A study was performed based on guidance from CLSI EP07-A2, CLSI EP07, 3rd ed. and CLSI EP37, 1st ed. | | | | | | | | | | | | | | | |
| | No Significant Interference (Interference within ± 10%) Potentially Interfering<br>Substance Interferent<br>Concentration IgE Target<br>(IU/mL) % Difference HAMA 0.100 mg/dL 99.0 0.4 RF 138 IU/mL 90.0 1.3 | | | | | | | | | | | | | | | |
| | Potentially Interfering Drugs<br>A study was performed based on guidance from CLSI EP07-A2 and CLSI EP37, 1st ed. Each | | | | | | | | | | | | | | | |
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# werten
#### Precision
The precision of the Quantia IgE assay is < 6% Total CV for Level II and a mixture of Levels I and II Control, and ≤ 15% for Level I Control (Quantia Ferritin/Myoglobin/IgE Control). Studies were performed using CLSI protocol NCCLS EP15-A.14 Representative data are summarized below.
| Control | Level I | Mixture of<br>I and II | Level II |
|----------------|---------|------------------------|----------|
| N | 50 | 50 | 50 |
| Mean (IU/mL) | 46.3* | 228.3 | 414.6 |
| Within Run %CV | 13.8 | 2.9 | 2.1 |
| Total %CV | 14.5 | 3.4 | 2.4 |
*Concentrations near the LOQ value produce slightly higher CVs.
#### substance was tested at 1 analyte level (approximately 99.0 IU/mL).
| No Significant Interference (Interference within ± 10%) | |
|---------------------------------------------------------|------------------------------|
| Potentially Interfering Drug | Interferent Level<br>(mg/dL) |
| Acetaminophen | 15.6 |
| Acetylcysteine | 15.0 |
| Acetylsalicylic acid | 3.00 |
| Ampicillin | 7.50 |
| Cefoxitin | 660 |
| Cetirizine | 0.435 |
| Cyclosporine | 0.180 |
| Diphenhydramine | 0.0774 |
| Doxycycline | 1.80 |
| Fexofenadine | 0.116 |
| Heparin | 330 units/dL |
| Ibuprofen | 21.9 |
| Levodopa | 0.750 |
| Methyldopa | 2.25 |
| Metronidazole | 12.3 |
| Mometasone | 0.000045 |
| Phenylbutazone | 32.1 |
| Prednisolone | 0.120 |
| Rifampicin | 4.80 |
| Salicylic Acid | 2.86 |
| Theophylline | 6.00 |
Interferences from medication or endogenous substances may affect results.
### Precision
Within-Laboratory Precision
A study was performed based on guidance from CLSI EP05-A3. Testing was conducted using 3 lots of the Quantia IgE reagent, 1 lot of the Quantia IgE Calibrator, 1 lot of the Quantia Ferritin/Myoglobin/IgE Control, and 1 instrument. Two controls, 1:1 mixture of control I and II, and 2 serum panels were tested in a minimum of 2 replicates, twice per day on 20 days.
Additional testing was conducted with 3 native serum pools using the same number of reagent, calibrator, and control lots and instruments utilized in the 20-day study. The 3 serum panels (Panel A, B, and C) were tested in a minimum of 2 replicates, twice per day on 12 days.
The performance from a representative combination is shown in the following table.
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# we
| | Key to Symbols |
|--|----------------|
| | |
- • ---- New symbol is added.
| | | Mean | Within-Run<br>(Repeatability) | | Within-Laborator<br>(Total)a | |
|--------------------------|----|---------|-------------------------------|-----|------------------------------|-----|
| Sample | n | (IU/mL) | SD | %CV | SD | %CV |
| Panel 50 IU/mL | 80 | 53.4 | 2.1 | 3.9 | 2.1 | 3.9 |
| Control I | 80 | 69.6 | 1.9 | 2.7 | 2.0 | 2.8 |
| 1:1 Mix Control I and II | 80 | 242.7 | 1.7 | 0.7 | 2.3 | 1.0 |
| Control II | 80 | 418.0 | 2.5 | 0.6 | 3.7 | 0.9 |
| Panel 800 IU/mL | 80 | 881.2 | 8.6 | 1.0 | 11.5 | 1.3 |
| Panel A | 48 | 26.9 | 0.9 | 3.3 | 1.3 | 4.9 |
| Panel B | 48 | 139.1 | 0.7 | 0.5 | 1.9 | 1.3 |
| Panel C | 48 | 461.6 | 1.7 | 0.4 | 5.4 | 1.2 |
^a Includes within-run, between-run, and between-day variability.
#### Key to Symbols
. • • Rx ONLY
use by or on the order of a
hysician only (applicable to USA
Massification only).
### ARCHITECT cSystems Assays Parameters
| Configure assay parameters - General | | | | |
|-------------------------------------------|-------------------------|-------------------------------|---------------------------------|---------------------------|
| ● General | O Calibration | O SmartWash | O Results | O Interpretation |
| Assay: IgE<br>Number: 2908 | | Type: Photometric | Version: + | |
| Run controls for onboard reagents by: Lot | | | | |
| ● Reaction definition | O Reagent / Sample | | O Validity checks | |
| Reaction mode: End up | | | | |
| | Primary / Secondary | | | Read times |
| | Wavelength: 572 / None | | | Main: 26 - 27 |
| | Last required read: 27 | | | |
| | Absorbance range: | | Color correction: | |
| | Sample blank type: Self | | Blank: 19 - 20 | |
| O Reaction definition | ● Reagent / Sample | | O Validity checks | |
| Reagent: IGEOB<br>Diluent: Saline | | | Reagent volume: 140 | R1<br>70<br>R2 |
| Diluent dispense mode: Type 0 | | | Water volume: | |
| | | | Dispense mode: Type 0 | Type 2 |
| | Diluted sample | Diluent | Water | Default dilution |
| Dilution name Sample | | | | Dilution factor |
| STANDARD: 3.5 | | | | 1:1 |
| Dil 1 : 15.0 | 3.5 | 135 | | 1:10.00 O |
| O Reaction definition | O Reagent / Sample | | ● Validity checks | |
| Reaction check: | Rate Ratio | | | |
| | | | Read time: | A 26-27<br>B 18-19 |
| | | | Calculation limits:<br>Minimum: | 0.5000 - 9.0000<br>0.0500 |
| | | Maximum absorbance variation: | | |
| O Calibrators | ● Volumes | | O Intervals | O Validity checks |
| Calibrator: IgE | | | Diluted sample | |
| | Calibrator level | Sample | Diluent Water | |
| | Blank: Water | 3.5 | | |
| | Cal 1: IgE1 | 3.5 | | |
| | Cal 2: IgE2 | 3.5 | | |
| | Cal 3: IgE3 | 3.5 | | |
| | Cal 4: IgE4 | 3.5 | | |
| | Cal 5: IgE5 | 3.5 | | |
---- (section deleted)
{12}------------------------------------------------
| Quantia IgE Serum/Plasma-Conventional and SI Units | | |
|--------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------|
| Configure assay parameters - Results | | |
| O General | O SmartWash<br>● Results | O Interpretation |
| Assay: IgE<br>Dilution default range: | | Assay number: 2908<br>Result units: IU/mL |
| | Low-Linearity: 25.0<br>High-Linearity: 1000.0 | |
| Gender and age specific ranges:** | | |
| GENDER<br>AGE (UNITS) | NORMAL | EXTREME |
| Configure result units | | |
| Assay: IgE<br>Version: †<br>Result units: IU/mL<br>Decimal places: | 1 [Range 0 - 4] | |
| Correlation factor: 1.0000 | | |
| Intercept: 0.0000 | | |
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Image /page/13/Picture/0 description: The image shows the word "werfen" in a bold, sans-serif font. The text is a dark blue color. The background is white.
| Reason Submission<br>Qualifies as Special 510(k) | This submission for the Quantia IgE assay meets the criteria for a<br>Special 510(k) outlined in the FDA guidance “The Special 510(k)<br>Program: Guidance for Industry and Food and Drug<br>Administration Staff” (September 13, 2019) based on the following: |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The proposed change is submitted by the manufacturer legally authorized to market the existing device. Performance data is needed to evaluate the change. There is a well-established method to evaluate the change. The data can be reviewed in a summary or risk analysis format. |
| | In addition, the changes in this submission do not introduce: Changes to indications for use or intended use Changes to operating principle |
| Design Control Activities | The following studies were performed to verify performance of the<br>modified device on ARCHITECT c8000 instrument: | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | • Precision | |
| | • | Limit of blank (LoB) |
| | • | Limit of detection (LoD) |
| | • | Limit of quantitation (LoQ) |
| | • | Linearity |
| | • | Extended Measuring Interval/Autodilution |
| | • | Prozone |
| | • | Interferences |
| | • | Tube type/Matrix comparison |
| | • | Method Comparison |
| | • | IgE International Standard recovery |
{14}------------------------------------------------
### Comparison to Predicate Device (K050493)
The following is a description of the similarities and differences between the predicate device; Quantia IgE (K050493), and the subject device, modified Quantia IgE, to demonstrate substantial equivalence.
| Similarities | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate Device (K050493) | Subject Device |
| Indications for Use /<br>Intended Use | Quantia IgE is an automated latex enhanced immunoassay for the quantitative in vitro determination of immunoglobulin E (IgE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies. | Quantia IgE is an automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (IgE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies. |
| Measurand | IgE | Same |
| Type of Test | Quantitative | Same |
| Methodology | Latex-enhanced immuoturbidimetric assay | Same |
| Sample Type | Human serum or plasma (EDTA, heparin, citrate) | Same |
| Cut-off | N/A | Same |
| Kit Composition | The Quantia IgE kit consists of:<br>Latex Reagent: Suspension of polystyrene latex particles coated with anti-human IgE monoclonal antibody containing bovine serum albumin, glycine buffer, stabilizers and preservative. Reaction Buffer: Glycine buffer containing bovine serum albumin, stabilizers and preservative. | Same |
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Image /page/15/Picture/0 description: The image shows the word "werfen" in a bold, sans-serif font. The color of the text is a dark blue. The word is presented on a white background.
| Differences | | |
|-----------------------------|----------------------------|---------------------|
| Item | Predicate Device (K050493) | Subject Device |
| Linearity | 25.0 - 1000.0 IU/mL | 20.0 - 1000.0 IU/mL |
| Limit of Blank (LoB) | Not defined. | 6.2 IU/mL |
| Limit of Detection (LoD) | 12.9 IU/mL | 11.6 IU/mL |
| Limit of Quantitation (LoQ) | 25.0 IU/mL | 20.0 IU/mL |
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device (K050493 Quantia IgE) identified at the beginning of this section.
