(157 days)
Not Found
No
The description focuses on standard turbidimetric immunoassay principles and does not mention any AI/ML components or algorithms.
No
The device is a reagent for the quantitative determination of IgG immunoglobulins, aiding in diagnosis rather than treating a condition.
Yes
Explanation: The device is used for the "quantitative determination of IgG immunoglobulins," and "the measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," explicitly stating its role in diagnosis.
No
The device description clearly states it consists of two reagents (R1 buffer and R2 antiserum) which are physical components, not software. The mechanism of action involves chemical reactions and light scattering measured by a turbidimeter, indicating a hardware-dependent system.
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 (serum, plasma, CSF) outside of the body to provide information for diagnosis.
- Device Description: The description details reagents (R1 buffer and R2 antiserum) that are used to react with components in the biological sample (human IgG). This reaction is performed in vitro (in a test tube or similar container).
- Measurement Principle: The device utilizes turbidimetry to measure the reaction between the sample and the reagents. This is a common method used in clinical laboratories for in vitro diagnostic testing.
- Clinical Significance: The intended use also 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 the diagnostic purpose of the device.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
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 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, JJE
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 IgG 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. In the AU procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as 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)
The IgG assay was selected as the representative immunoturbidimetry assay for the DxC 700 AU Clinical Chemistry Analyzer. To demonstrate comparability between the predicate device (AU5800) and the candidate device (DxC 700 AU), the following performance testing was conducted on the IgG Assay: Method Comparison, Linearity, Sensitivity, Reference Interval, Interference, In use (On board) & Calibrator Stability, Precision, Prozone, Auto-dilution.
All other immunoturbidimetric reagent applications will be validated using risk management, design controls, and FDA's Guidance for Industry and FDA staff - Replacement Reagent and Instrument Family Policy. The core validation principles are linearity, method comparison, precision, sensitivity, interference, reference interval, prozone tolerance and on-board/calibration frequency studies. Reference ranges will be verified.
The data contained in the Premarket Notification supports the substantial equivalence of the IgG reagent to the predicate IgG reagent already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, imprecision and sensitivity experiments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Serum & Plasma: With-run:
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2017
Beckman Coulter, Inc. Geraldine Fuentespina Manager, Regulatory Affairs 250 S. Kraemer Blvd., Mail Stop E1.SE.01 Brea. CA 92821
Re: [510(k) Number] K162208 Trade/Device Name: 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. JJE Dated: November 29, 2016 Received: November 30, 2016
Dear Ms. Fuentespina:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kelly Oliner -S
FOR.
Leonthena R. Carrington, MS, MBA, MT (ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K162208
Device Name 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 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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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is written in bold, black, sans-serif font above the text "COULTER", which is also in bold, black, sans-serif font.
1.0 Submitted By
Geraldine Fuentespina Manager, Regulatory Affairs Beckman Coulter, Inc. 250 S. Kraemer Blvd. Mail Stop: E1.SE.01 Brea, CA 92821 Telephone: (714) 961-3777 Fax: (714) 961-4234
2.0 Date of Preparation
6 January 2017
3.0 Device Name(s)
Proprietary Name: laG Common Name: laG Classification: Class II Classification Name: Immunoglobulins A, G, M, D, E Immunological Test System Product Codes: CFN Requlation Number: 21 CFR 866.5510
4.0 Predicate Device
| Candidate(s) | Predicate | Manufacturer |
|---|---|---|
| IgG | Olympus IgG Reagent | |
| (K073490) | 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 IgG 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. In the AU procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as 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 circle with two white curved lines inside, followed by the words "BECKMAN" in bold black letters on the first line and "COULTER" in bold black letters on the second line. The logo is simple and modern, with a focus on the company name.
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 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
The formulation of the candidate IgG reagent and the predicate IgG reagent are identical. The following tables show the similarities and differences between the predicate device.
| Feature | Predicate Device: IgG Reagent (K073490) | Candidate Device: IgG Reagent |
|---|---|---|
| Item Number | IgG (OSR6X172) reagent | Same |
| Intended Use | System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU analyzers | Same |
| Measurement | Quantitative | Same |
| Instrument Required | AU400/400ᵉ/480, | |
| AU600/640/640ᵉ/680 and | ||
| AU2700/5400/AU5800 | ||
| Beckman Coulter Analyzers | AU400/400ᵉ/480, | |
| /640/640ᵉ/680, | ||
| AU2700/5400/AU5800 and | ||
| DxC 700 AU Beckman | ||
| Coulter Analyzers. | ||
| Methodology | Immunoturbidimetric | Same |
| Antibody | Goat anti-IgG | Same |
| Reagent form and storage | Liquid, on-board storage | Same |
| Specimen Type | Serum, EDTA or Lithium heparin plasma, and cerebrospinal fluid | Same |
| Calibrator | Serum Protein Multi-Calibrator (Cat # ODR3021) | Same |
| Onboard Stability | 90 Days | Same |
| Calibration Stability | Serum & Plasma | |
| 90 Days | Same | |
| CSF | ||
| 2 Days | Same | |
| Analytic Range | Serum & Plasma | |
| 75 – 3000 mg/dL | Same | |
| CSF | ||
| 2 - 50 mg/dL | Same |
Table 7.0 - IgG Predicate Device Comparison Table
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| Feature | | Predicate Device:
IgG Reagent
(K073490) | Candidate Device:
IgG Reagent |
|--------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Serum &
Plasma | With-run:
$\le$ ±3.5% mg/dL
Total:
$\le$ ±6.0% mg/dL | Same |
| | CSF | With-run:
$\le$ ±6.0% or ±0.4 mg/dL
Total:
$\le$ ±7.5% or ±0.5mg/dL | Same |
| Sensitivity | Serum &
Plasma | LoQ:
75 mg/dL | Same |
| | CSF | LoQ:
2 mg/dL | Same |
| Interference | Serum &
Plasma | Bilirubin: Interference less
than 3% up to 40 mg/dL
Bilirubin
Hemolysis: Interference less
than 3% up to 500 mg/dL
Hemolysate
Lipemia: Interference less
than 5% up to 1000 mg/dL
Intralipid
RF: Interference less than
7% up to 1200 IU/mL
Rheumatoid
Factor | Similar
The criteria for No
Significant Interference
(NSI) is recovery within 10%
of the initial value.
Bilirubin: NSI up to 40
mg/dL Bilirubin
Hemolysis: NSI up to 500
mg/dL Hemolysate
Lipemia: NSI up to 1000
mg/dL Intralipid
RF: NSI up to 1200 IU/mL
Rheumatoid
Factor |
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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape on the left side, with two white curved lines inside. To the right of the oval is the text "BECKMAN" in bold, black letters, stacked on top of the word "COULTER", also in bold, black letters.
| Feature | Predicate Device:
IgG Reagent
(K073490) | Candidate Device:
IgG Reagent |
|---------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| CSF | Bilirubin: Interference less
than 3% up to 40 mg/dL
Bilirubin | Similar
The criteria for No
Significant Interference
(NSI) is recovery within 10%
of the initial value. |
| | Hemolysis: Interference less
than 3% up to 500 mg/dL
Hemolysate | Bilirubin: NSI up to 40
mg/dL Bilirubin |
| | Lipemia: Interference less
than 5% up to 1000 mg/dL
Intralipid | Hemolysis: NSI up to 500
mg/dL Hemolysate |
| | RF: Interference less than
7% up to 1200 IU/mL
Rheumatoid
Factor | Lipemia: NSI up to 1000
mg/dL Intralipid
RF: NSI up to 1200 IU/mL
Rheumatoid
Factor |
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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line, both in a bold, sans-serif font.
8.0 Comparison testing
IgG assay was selected as the representative immunoturbidimetry assay for the DxC 700 AU Clinical Chemistry Analyzer. In order to demonstrate the comparability between the predicate device, AU5800 and the candidate device, DxC 700 AU, the following performance testing was conducted on the IgG Assay:
- Method Comparison Linearity Sensitivity Reference Interval Interference In use (On board) & Calibrator Stability Precision Prozone Auto-dilution
All other immunoturbidimetric reagent applications will be validated using risk management, design controls, and FDA's Guidance for Industry and FDA staff -Replacement Reagent and Instrument Family Policy. The core validation principles are linearity, method comparison, precision, sensitivity, interference, reference interval, prozone tolerance and on-board/calibration frequency studies. Reference ranges will be verified.
9.0 Summary of Performance Data
The data contained in the Premarket Notification supports the substantial equivalence of the IqG reagent to the predicate IgG reagent already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, imprecision and sensitivity experiments.
10.0 Conclusion
The IqG Reagent on the DxC 700 AU Clinical Chemistry Analyzer is identical in design and composition as the IgG Reagent on AU Systems cleared under K073490. Method comparison, linearity, sensitivity, reference interval, interference, precision, prozone, stability testing demonstrates that the assay performance is substantially equivalent between the candidate system and the predicate.
Substantial equivalence of the immunoturbidimetric assays has been demonstrated through performance of IgG. Performance testing conducted verifies that the device functions as intended and that design specifications have been satisfied.
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.