(474 days)
Not Found
No
The device description and performance studies focus on standard in vitro diagnostic methods (turbidimetry) and do not mention any AI/ML components or algorithms.
No.
This device is an in vitro diagnostic (IVD) reagent used for the quantitative determination of IgG immunoglobulins, aiding in the diagnosis of specific conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates its role in diagnosis.
No
The device is described as consisting of two reagents (R1 buffer and R2 antiserum) and relies on turbidimetry for measurement, indicating it is a hardware-based in vitro diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid". This is a classic description of an in vitro diagnostic test, as it involves analyzing biological samples outside of the body to provide information for diagnosis.
- Device Description: The description details reagents used to react with components in the sample (human IgG with anti-human IgG antibodies) to produce a measurable result (insoluble aggregates causing light scattering). This process is performed in vitro (in a test tube or similar container).
- Input Imaging Modality and Anatomical Site: The "Not Applicable (In vitro diagnostic test)" entries for these fields further confirm that the device operates on samples outside the body, not directly on a patient's anatomy.
- Performance Studies: The performance studies described (Method Comparison, Linearity, Sensitivity, Precision, Interference, Reference Interval) are standard types of studies conducted to validate the performance of IVD devices.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CFN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence is demonstrated through non-clinical (bench) studies. 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 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.
- Sample Type: Serum, N=147, Slope=1.015, Intercept=-25.422, R=0.9981
- Sample Type: CSF, N=114, Slope=0.998, Intercept=0.1141, R=0.9995
Linearity/Reportable Range:
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.
- Serum: Linear Range 75-3,000 mg/dL, Linear From 73.2868, Linear To 3261.9190, Pass
- CSF: Linear Range 2-50 mg/dL, Linear From 1.9, Linear To 53.0, Pass
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". An 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 10-fold for 5 days.
- Serum: LOB 5.6 mg/dL, LOD 8.6 mg/dL, LOQ 18.5 mg/dL at 10% CV
- CSF: LOB 0.11 mg/dL, LOD 0.31 mg/dL, LOQ 0.63 mg/dL at 20% CV
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.
20-day Precision Data Summary:
Serum:
- Sample Levels 1 (503.99 mg/dL): Repeatability (Within Run) 5.8 SD, 1.2 CV%, Within Laboratory (Total) 6.3 SD, 1.2 CV%
- Sample Levels 2 (1797.53 mg/dL): Repeatability (Within Run) 43.1 SD, 2.4 CV%, Within Laboratory (Total) 43.2 SD, 2.4 CV%
- Sample Levels 3 (2576.22 mg/dL): Repeatability (Within Run) 86.9 SD, 3.4 CV%, Within Laboratory (Total) 94.9 SD, 3.7 CV%
- Sample Levels 4 (88.31 mg/dL): Repeatability (Within Run) 1.6 SD, 1.8 CV%, Within Laboratory (Total) 4.3 SD, 4.9 CV%
- Sample Levels 5 (835.56 mg/dL): Repeatability (Within Run) 7.2 SD, 0.9 CV%, Within Laboratory (Total) 14.8 SD, 1.8 CV%
CSF:
- Sample Levels 1 (4.14 mg/dL): Repeatability (Within Run) 0.2 SD, 4.7 CV%, Within Laboratory (Total) 0.2 SD, 5.6 CV%
- Sample Levels 2 (11.20 mg/dL): Repeatability (Within Run) 0.2 SD, 2.1 CV%, Within Laboratory (Total) 0.4 SD, 3.1 CV%
- Sample Levels 3 (36.32 mg/dL): Repeatability (Within Run) 0.6 SD, 1.6 CV%, Within Laboratory (Total) 0.9 SD, 2.6 CV%
5-Day Precision Data Summary:
Serum:
- Sample Levels 1 (481.20 mg/dL): Repeatability (Within Run) 0.8% CV, 3.67 SD; Within Laboratory (Total) 1.0% CV, 4.63 SD; Reproducibility 1.0% CV, 4.63 SD
- Sample Levels 2 (1669.57 mg/dL): Repeatability (Within Run) 1.5% CV, 24.45 SD; Within Laboratory (Total) 1.7% CV, 29.04 SD; Reproducibility 1.7%, 29.07 SD
- Sample Levels 3 (2404.48 mg/dL): Repeatability (Within Run) 2.8% CV, 66.69 SD; Within Laboratory (Total) 3.6 % CV, 86.08 SD; Reproducibility 3.6 % CV, 86.08 SD
CSF:
- Sample Levels 1 (3.53 mg/dL): Repeatability (Within Run) 1.7% CV, 0.06 SD; Within Laboratory (Total) 4.4% CV, 0.16 SD; Reproducibility 4.7% CV, 0.16 SD
- Sample Levels 2 (11.31 mg/dL): Repeatability (Within Run) 0.9% CV, 0.10 SD; Within Laboratory (Total) 1.9% CV, 0.22 SD; Reproducibility 1.9% CV, 0.22 SD
- Sample Levels 3 (37.18 mg/dL): Repeatability (Within Run) 0.9% CV, 0.33 SD; Within Laboratory (Total) 1.4% CV, 0.50 SD; Reproducibility 1.4% CV, 0.50 SD
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 candidate IgG assay met the performance specifications as stated in the IgG reagent IFU.
- Serum: Intralipid (1000 mg/dL), Bilirubin (40 mg/dL), Hemolysate (500 mg/dL), RF (1200 IU/mL) - Pass
- CSF: Bilirubin (36 mg/dL), Hemolysate (500 mg/dL) - Pass
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.
- Serum (Adult): 635 - 1,741 mg/dL - Pass
- CSF: 15 – 20 years: 3.5 mg/dL ± 2.0 mg/dL; 21 - 40 years: 4.2 mg/dL ± 1.4 mg/dL; 41 - 60 years: 4.7 mg/dL ± 1.0 mg/dL - N/A* (*Literature reference used)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported are:
- Sensitivity (Limit of Quantitation (LOQ), Limit of Detection (LOD), Limit of Blank (LOB))
- Precision (Repeatability (Within Run), Within Laboratory (Total), Reproducibility)
- Correlation Coefficient (R) for Method Comparison Studies
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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.
4
Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red symbol on the left and the company name "BECKMAN COULTER" on the right. The symbol is a stylized, abstract design with curved lines, resembling a stylized letter "B". The company name is written in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".
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 Clinical
Chemistry Analyzer)
(K162208) | Candidate Device:
IgG Reagent
(DxC 500 AU Clinical
Chemistry Analyzer) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | System reagent for the
quantitative determination of IgG
immunoglobulins in human
serum, plasma, and
cerebrospinal fluid on Beckman
Coulter AU analyzers | Same; updated
instrument family
branding only.
System reagent for the
quantitative determination
of IgG immunoglobulins in
human serum, plasma,
and cerebrospinal fluid on
Beckman Coulter AU/DxC
AU analyzers |
| Measurement | Quantitative | Same |
| Instrument Required | AU400/400e/480, AU640/640e
/680, AU2700/5400/AU5800 and
DxC 700 AU Beckman Coulter
Analyzers. | AU480, AU680, AU5800,
DxC 500 AU and DxC
700 AU Beckman Coulter
Analyzers. |
| 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 Clinical
Chemistry Analyzer)
(K162208) | Candidate Device:
IgG Reagent
(DxC 500 AU Clinical
Chemistry Analyzer) |
| Specimen Type | Serum, EDTA or Lithium heparin
plasma, and cerebrospinal fluid | Same |
| Calibration | Serum Protein Multi-Calibrator
(Cat # ODR3021) | Same |
| Onboard Stability | 90 Days | Same |
| Calibration
Stability | Serum &
Plasma
90 Days | Same |
| | CSF
2 Days | Same |
| Analytical
Range | Serum &
Plasma
75 - 3000 mg/dL | Same |
| | CSF
2- 50 mg/dL | Same |
| Precision | Serum &
Plasma
Within-run Precision:
≤ 3.5% CV
Total Precision: