(54 days)
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.
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.
Here's an analysis of the provided text regarding the N Latex Ferritin device, focusing on the acceptance criteria and study details.
The provided document describes a 510(k) submission for N Latex Ferritin, an in vitro diagnostic reagent. The goal of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (also N Latex Ferritin, K950707). As such, the "acceptance criteria" are predominantly about demonstrating comparable performance to the predicate and meeting standard analytical validation requirements for precision and correlation. The study described is a performance comparison study against the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (N Latex Ferritin) |
|---|---|
| Correlation to Predicate Device | Correlation coefficient of 1.0 |
| Y-intercept value of -0.87 | |
| Slope of 1.05 | |
| Inter-Assay Precision | Ranged from 1.2% to 3.1% |
| Intra-Assay Precision | Ranged from 1.0% to 4.6% |
Note: The document does not explicitly state pre-defined acceptance criteria values for these metrics (e.g., "correlation coefficient must be ≥ 0.95"). However, the presented results (especially a correlation of 1.0) are clearly intended to demonstrate acceptable performance for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation Study: 79 samples
- Sample Size for Precision Study: Three levels of human serum pools. (The exact number of individual samples within these pools is not specified, but this refers to the number of distinct concentrations tested).
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a retrospective study, as it evaluates samples against an existing, legally marketed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is an in vitro diagnostic device measuring a biomarker (ferritin concentration). The "ground truth" for the test set is established by the predicate device's measurement. There are no human experts "establishing ground truth" in the way one might for image interpretation or diagnosis. The predicate device itself acts as the reference.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this is an in vitro diagnostic device comparison study. There is no human adjudication process involved in determining the "truth" for the test samples in this context. The predicate device provides the reference measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is an in vitro diagnostic device that provides a quantitative measurement of ferritin. It does not involve human readers interpreting cases, and therefore, an MRMC study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, this is a standalone study. The N Latex Ferritin device (reagent and Behring Nephelometer System) operates independently to provide a ferritin concentration measurement. Its performance is evaluated directly through correlation and precision studies, without human intervention in the measurement process itself.
7. The Type of Ground Truth Used
- The "ground truth" in this context is established by the measurement obtained from the legally marketed predicate device (N Latex Ferritin, K950707). The study aims to show that the new device produces results that correlate strongly with, and are as precise as, the predicate device.
8. The Sample Size for the Training Set
- Not explicitly stated or applicable in the traditional sense. In vitro diagnostic reagents like N Latex Ferritin are typically developed and optimized through extensive R&D, rather than "trained" on a dataset in the way a machine learning algorithm is. The document describes a comparison study of the final product with a predicate device. The information related to defining the standard curve, optimizing reagents, etc., would be part of the manufacturing and R&D process, not necessarily a "training set" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated or applicable. Similar to point 8, the "training set" concept doesn't directly apply. The method relies on known concentrations of ferritin for calibration standards, which are established through analytical chemistry principles and reference materials, but this isn't a "ground truth for training" in the common understanding of the term for AI/ML devices.
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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.
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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) |
§ 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).