(123 days)
Not Found
No
The device description and performance studies focus on immunochemical reactions and correlation with predicate devices, with no mention of AI or ML algorithms.
No
The device is an in vitro diagnostic reagent and a control for assessing precision and analytical bias. Its purpose is to quantify immunoglobulins and determine protein levels, which aids in diagnosis rather than providing direct therapy.
Yes.
The device's intended use is for the quantitative determination of immunoglobulins to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents, which is a diagnostic purpose.
No
The device description clearly indicates it is composed of physical reagents (antisera and a lyophilized control product) used in an immunochemical reaction, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for the "quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF)". This involves testing samples taken from the human body in vitro (outside the body) to provide information for diagnosis.
- Indications for Use: The indications state that the measurement of immunoglobulins "aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly links the test results to diagnostic purposes.
- Device Description: The description details how the device works by detecting proteins in human body fluids through an immunochemical reaction.
- N/T Protein Control LC: While the control is for quality control, its purpose is to ensure the accuracy and precision of the in vitro diagnostic tests being performed with the antisera.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM): In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BN™ Systems. Measurement of immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
N/T Protein Control LC: N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF, IgG in urinc, transferrin in urine, albumin in urine and CSF, a1-microglobulin in urine and total protein in urine and CSF, using the BNTM Systems.
Product codes (comma separated list FDA assigned to the subject device)
CFN, JJY
Device Description
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM): Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
N/T Protein Control LC: The N/T Protein Control LC is a multi-analyte, lyophilized, polygeline and rabbit albumin based product.
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)
Method Comparison Data:
Protein: IgG, Coefficient of Correlation: 0.99 (y = 0.926 x - 0.34 mg/L)
The studies included in this submission demonstrate correlation to and equivalent performance between the predicate IMMAGE® IGU assay and the N Antisera to Human IgG urine assay.
The N/T Protein Control LC, modified to include IgG urine values, is substantially equivalent in Intended Use to the Dimension Vista® Protein 3 Control.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
· MAR 2 4 2009
510 (k) Summary for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) and N/T Protein Control LC
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1. Manufacturer's Name, Address, Telephone, and Contact Person,
Manufacturer: Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany
Contact Information: Helen M. Lee Siemens Healthcare Diagnostics Glasgow Business Community 500 GBC Drive M/S 514 Newark, DE 19714-6101 302.631.8706 302.631.6299 (fax)
Date of Preparation: November 6, 2008
2. Name of Product:
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) N/T Protein Control LC
Class: Immunological Test System; Quality Control Material, CLASS II 21 CFR 866.5510 Panel: IMMUNOLOGY Product Code: CFN
3. Identification of the Legally Marketed Device:
Beckman Coulter IMMAGE® Immunochemistry Systems Urine Immunoglobulin G (IGU) K951635.
Dimension Vista® Protein 3 Control K072435
1
4. Device Descriptions:
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
N/T Protein Control LC
The N/T Protein Control LC is a multi-analyte, lyophilized, polygeline and rabbit albumin based product.
5. Device Intended Uses:
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BN™ Systems. Measurement of immunoqlobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
N/T Protein Control LC
N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF; IgG in urine, transferrìn in urine, albumin in urine and CSF. a1-microglobulin in urine and total protein in urine and CSF using the BNTM Systems.
2
6. Medical Device to which equivalence is claimed and comparison information:
The IMMAGE® Immunochemistry System Urine Immunoglobulin G (IGU) was determined to be substantially equivalent in 510 (k) Premarket Notification K963974 and is the predicate for adding the urine sample matrix to the N Antisera IqG assay.
Method Comparison Data
| Protein | Coefficient of Correlation | |
|---|---|---|
| IgG | $y = 0.926 x - 0.34 mg/L$ | 0.99 |
The current N Antisera to Human Immunoglobulins (IgG, IqA. and IgM) was determined to be substantially equivalent in 510 (k) Premarket Notification K042735. The operating principle and reagent composition have not changed. For your convenience, the sections with changes have been underlined in the Draft Instructions for Use included in this submission.
The Dimension Vista® Protein 3 Control (K072435) is the predicate for adding the urine sample matrix to the N/T Protein Control LC. The modified N/T Protein Control LC, like the predicate is intended to be used as an assayed accuracy and precision control for Immunoglobulin G in urine.
7. Conclusion:
The studies included in this submission demonstrate correlation to and equivalent performance between the predicate IMMAGE® IGU assay and the N Antisera to Human IgG urine assay.
The N/T Protein Control LC, modified to include IgG urine values, is substantially equivalent in Intended Use to the Dimension Vista® Protein 3 Control.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Public Health Service
MAR 2 4 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc c/o Ms. Helen M. Lee Regulatory Affairs and Compliance Manager 500 GBC Drive, M/S 514 Newark, DE 19714
Re: K083445
Trade/Device Name: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) 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, JJY Dated: February 12, 2009 Received: February 13, 2009
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page 2 - Ms. Lee
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you abon office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, oblease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of I at 001:57) - 1 07 quosteric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other prease of the mation on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Josephine Bautista
Maria Chan, Ph.D.
Director
Sivision of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K083445
Device Name: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Indication For Use:
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BNTM Systems. Measurement of immunoglobulins aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Kimberly Stewart
Office of In Vito Diagnostic Device Evaluation and Safety
510(k) K083445
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Indication for Use
510(k) Number (if known): K083445
Device Name: N/T Protein Control LC
Indication For Use:
N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF, IgG in urinc, transferrin in urine, albumin in urine and CSF, a1-microglobulin in urine and total protein in urine and CSF, using the BNTM Systems.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083445