(54 days)
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No
The description details a standard immunonephelometry assay based on antibody-antigen binding and light scattering, with no mention of AI or ML techniques for data analysis or interpretation.
No
The device is described as an in vitro diagnostic reagent used for quantitative determination of ferritin in human samples to aid in diagnosis, not to treat or cure a disease.
Yes
This device is described as an "in vitro diagnostic reagent for the quantitative determination of ferritin" and states that it "aids in the diagnosis of diseases." This explicitly indicates its diagnostic purpose.
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests. The description clearly outlines the use of polystyrene latex particles and their agglutination reaction, indicating a physical component and chemical process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that N Latex Ferritin is an "in vitro diagnostic reagent for the quantitative determination of ferritin in human serum or heparinized plasma". This clearly indicates its use outside of the body to diagnose or aid in the diagnosis of diseases.
- Device Description: The description details how the reagent interacts with a biological sample (human serum or heparinized plasma) to measure a specific analyte (ferritin). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance studies like correlation and precision, which are standard for evaluating the analytical performance of diagnostic tests, further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
N Latex Ferritin is an in vitro diagnostic reagent for the quantitative determination of ferritin in human serum or heparinized plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Product codes (comma separated list FDA assigned to the subject device)
DBF
Device Description
Polystyrene latex particles coated with specific antibodies to human ferritin are agglutinated when mixed with samples containing ferritin. The intensity of scattered light in the nephelometer is proportional to the ferritin content of the sample; therefore, the ferritin concentration can be quantitated by comparison to dilutions of a standard of known concentration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation: The proposed N Latex Ferritin assay was compared to the current N Latex Ferritin assay by evaluating 79 samples ranging from 12 to 440 ug/l. A correlation coefficient of 1.0 was obtained, with a v-intercept value of -0.87 and a slope of 1.05.
Precision: Precision studies were performed by the evaluation of three levels of human serum pools. The precision data were generated in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 1.2 to 3.1%, while the intra-assay precision ranged from 1.0 to 4.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).
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NOV 2 3 1999
510(k) Summary for N Latex Ferritin
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: K993273
Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
Contact Information:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276
Preparation date:
Device Name/ Classification: 2.
N Latex Ferritin:
Classification Number:
Class II (866.5340)
Ferritin immunological test system
September 29, 1999
ldentification of the Legally Marketed Device: 3.
N Latex Ferritin (K950707)
Device Description: 4.
Polystyrene latex particles coated with specific antibodies to human ferritin are agglutinated when mixed with samples containing ferritin. The intensity of scattered light in the nephelometer is proportional to the ferritin content of the sample; therefore, the ferritin concentration can be quantitated by comparison to dilutions of a standard of known concentration.
Device Intended Use: 5.
In vitro diagnostic reagent for quantitative determination of ferritin in human serum or heparinized plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems.
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Medical device to which equivalence is claimed and comparison information: 6.
There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination of ferritin in human serum or plasma. One such product is the Dade Behring N Latex Ferritin assay (K950707) The proposed N Latex Ferritin is substantially equivalent in intended use and results obtained to the current N Latex Ferritin. The proposed N Latex Ferritin, like the current N Latex Ferritin is intended to be used for the quantitative determination of ferritin using the Behring Nephelometer Systems.
7. Device Performance Characteristics:
Correlation:
The proposed N Latex Ferritin assay was compared to the current N Latex Ferritin assay by evaluating 79 samples ranging from 12 to 440 ug/l. A correlation coefficient of 1.0 was obtained, with a v-intercept value of -0.87 and a slope of 1.05.
Precision:
Precision studies were performed by the evaluation of three levels of human serum pools. The precision data were generated in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 1.2 to 3.1%, while the intra-assay precision ranged from 1.0 to 4.6%.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, composed of three curved lines that resemble wings or feathers.
NOV 2 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714
Re: K993273 Trade Name: N Latex Ferritin Regulatory Class: II Product Code: DBF Dated: September 29, 1999 Received: September 30, 1999
Dear Ms. Ayash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Jade Behring Inc. N I atex Ferritin 510(k) Notification
Indications Statement
Device Name:
N Latex Ferritin
Indications for Use:
N Latex Ferritin is an in vitro diagnostic reagent for the quantitative determination of ferritin in human serum or heparinized plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K993213 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | Over-The-Counter-Use (Optional Format 1-2-96) |