(28 days)
No
The device description and performance studies focus on immunochemical reactions and light scattering, with no mention of AI or ML.
No
This device is an in-vitro diagnostic reagent used for quantitative determination of immunoglobulins, aiding in diagnosis, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device aids in the "diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," which falls under the definition of a diagnostic device.
No
The device is an in-vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for "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)". This clearly indicates that the device is intended to be used outside of the body to diagnose or aid in the diagnosis of conditions.
- Device Description: The description details a reagent used in an "immunochemical reaction" with "human body fluids" to measure protein concentrations. This aligns with the definition of an in vitro diagnostic device.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K083445) and the name "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)" strongly suggests that this device is being submitted for regulatory clearance as an IVD, referencing a previously cleared IVD.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to analyze human samples for diagnostic purposes, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 BN II and BN ProSpec® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes
CFN
Device Description
The N Antiserum to Human IgG reagent containing animal serum, produced by immunization of rabbits with highly purified human immunoglobulin (
§ 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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December 13, 2023
Siemens Healthcare Diagnostics Products GmbH Dr. Sanja Matern Regulatory Affairs Manager, Head of Product Group, Regulatory Affairs Marburg Emil-von-Behring-Str. 76 Marburg, Hesse 35041 Germany
Re: K233663
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 Dated: November 15, 2023 Received: November 15, 2023
Dear Sanja Matern:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Indications for Use
510(k) Number (if known) K233663
Device Name
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Indications for Use (Describe)
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 II and BN ProSpec® System. Measurements of IgG aid 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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Special 510(k) Summary K233663
This summary of the special 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92, the Safe Medical Act of 1990, and follows the FDA guidance 'The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff', issued September 13, 2019.
1. Applicant
| Siemens Healthcare Diagnostics Products GmbH | |
|---|---|
| Emil-von-Behring-Str. 76 | |
| 35041 Marburg, Germany | |
| Contact Person: | Dr. Sanja Matern |
| Email: | sanja.matern@siemens-healthineers.com |
| Phone: | +49 (173) 3239008 |
| Date Prepared: | December 13, 2023 |
| 2. Device | |
| Name of Device: | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) |
| Regulation Number: | 21 CFR 866.5510 |
| Regulation Description: | Immunoglobulins A, G, M, D, and E immunological test system. |
| Product Code: | CFN |
| Device Classification Name: | Method, Nephelometric, Immunoglobulins (G, A, M) |
| Regulatory Class: | Class II |
| 510(k) Review Panel | Immunology (82) |
| 3. Predicate Device | |
| Name of Device / 510(k): | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) / K083445 |
| Regulation Number: | 21 CFR 866.5510 |
| Regulation Description: | Immunoglobulins A, G, M, D, and E immunological test system. |
| Product Code: | CFN |
| Device Classification Name: | Method, Nephelometric, Immunoglobulins (G, A, M) |
| Regulatory Class: | Class II |
| 510(k) Review Panel | Immunology (82) |
A Class 2 Device Recall N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) was issued on August 30, 2022. Despite there was no High Dose Hook (HDH) Effect claim for the determination of Immunoglobulin G in cerebrospinal fluid (CSF) samples, customer expectations were not met. Therefore, we now would like to introduce a HDH claim for CSF samples.
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4. Device Description / Test Principle
The Intended Use, Composition and test principle for the device N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) as stated in the Package Insert:
In-vitro diagnostic reagents for the quantitative determination of immunodlobulins (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 II and BN ProSpec® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The N Antiserum to Human IgG reagent containing animal serum, produced by immunization of rabbits with highly purified human immunoglobulin (