(275 days)
Not Found
No
The device description details a standard immunoturbidimetric assay based on chemical reactions and optical density measurements. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for calculating results from the measured turbidity. The performance studies also focus on traditional analytical performance metrics.
No.
This device is an in vitro diagnostic test for the quantitative determination of ferritin in human serum and plasma, used for diagnostic purposes. It does not provide any therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "For diagnostic purposes, the ferritin findings should always be assessed in conjunction with the patient's medical history, clinical examination and other findings." This clearly indicates its intended use in diagnostics.
No
The device description clearly outlines a laboratory-based immunoassay using reagents and a clinical-chemistry analyzer, indicating it is a hardware-dependent in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma". This clearly indicates the device is used to examine specimens derived from the human body outside of the body.
- Sample Type: The device uses "human serum and plasma", which are biological specimens from the human body.
- Purpose: The purpose is the "quantitative determination of ferritin", which is a specific analyte in the human body.
- Diagnostic Purpose: The text states "For diagnostic purposes, the ferritin findings should always be assessed in conjunction with the patient's medical history, clinical examination and other findings." This confirms the results are intended to be used in the diagnostic process.
- Method: The method described (immunoturbidimetric test) is a common technique used in in vitro diagnostics.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunological (in vitro) immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using clinical-chemistry analyzers.
Product codes
JMG
Device Description
The Ferritin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing ferritin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human ferritin antibodies (R₂ reagent) is added to mixture of the first step. The antibody-coated particles will bind to the ferritin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of ferritin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ferritin in the sample is directly proportional to the amount of turbidity formed.
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)
Precision:
Intra-Assay (ng/mL):
- Low: Mean 31.9, %CV 3.8 (N=21)
- Mid: Mean 144.4, %CV 1.4 (N=21)
- High: Mean 645.1, %CV 1.1 (N=21)
Inter-Assay (ng/mL):
- Sample 1: Mean 76.4, %CV 2.6
- Sample 2: Mean 347.4, %CV 2.2
Lower Detection Limit: 3 ng/mL
Linearity: 3 - 800 ng/mL
Method Comparison (Vs Enzymun-Test® Ferritin):
- Passing/Bablok: y = 1.04x + 4.8, r = 0.996, SEE = 13.68, N = 44
- Least Squares: y = 1.00x + 13.1, r = 0.997, SEE = 13.52, N = 44
Interfering substances (no interference at ≤ 10% error):
- Bilirubin: 68 mg/dL
- Hemoglobin: 500 mg/dL
- Lipemia: 1500 mg/dL
- Rheumatoid Factor: 100 IU/mL
Specificity:
- Liver Ferritin: 114.6%
- Spleen Ferritin: 112.0%
- Heart Ferritin: 1.7%
Key results summary: The device demonstrates good precision, linearity, and low detection limits. Method comparison shows strong correlation with the predicate device. The assay also exhibits robustness against common interfering substances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided for performance characteristics include Precision (%CV), Lower Detection Limit, Linearity range, and correlation coefficients (r, SEE) from method comparison studies. Specificity is reported as a percentage for different ferritin types.
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
§ 866.5340 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yvette Lloyd BOEHRINGER MANNEHEIM CORPORATION 2400 Bisso Lane P.O. Box 4117 Concord, CA 94524-4117 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
JUL 30 1597
K964282/S002 Re: Trade Name: Tina-quant® Ferritin Assay Regulatory Class: II Product Code: JMG Dated: April 28, 1997 Received: May 1, 1997
Dear Ms. Lloyd:
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 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 requirement, as set forth in the Quality System Regulation (QS) 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.
1
Page 2
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 Putman
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
2
K 9641882
JUL 3 0 1997
(
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation
2400 Bisso Lane
P.O. Box 4117
Concord, CA 94524-4117
(510) 674 - 0690, extension 8413 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Yvette Lloyd
Date Prepared: October 17, 1996 |
| 2. Device name | Proprietary name: Tina-quant® Ferritin Assay
Common name: Immunoturbidometric assay for the determination of Ferritin. |
| | Classification name: Ferritin immunological test system |
| 3. Predicate device | The Boehringer Mannheim Tina-quant® Ferritin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test® Ferritin assay (K860137). |
| | Continued on next page |
3
BOEHRINGER 10(k) Summary, Continued ORPORATION
| Function |
|---|
| 1 |
| : 8 : |
| 14 |
- |
| |
| |
| 100
|
| |
| 4.
Device
Description | The Ferritin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing ferritin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human ferritin antibodies (R₂ reagent) is added to mixture of the first step. The antibody-coated particles will bind to the ferritin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of ferritin present in the sample.
The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ferritin in the sample is directly proportional to the amount of turbidity formed. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.
Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of Ferritin. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Tina-quant® Ferritin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun- Test® Ferritin assay (K860137). |
Continued on next page
·
4
0(k) Summary, Continued
The following table compares the Tina-quant® Ferritin with the predicate 6. The following table compares in assay. Specific data on the performance of
device, Enzymun-Test® Ferritin assay. Specific data on the performance of Comparison device, Enzymun-Tester Formin usehe draft labeling in attachment 5.
the test have been incorporated into the draft labeling in attachment 5. to predicate the test have occh moorporate device in provided in attachment 6. device cont.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of Ferritin
·Sample type: Serum and plasma
Differences:
| Feature | Tina-quant® Ferritin | Enzymun-Test® Ferritin |
|---|---|---|
| Reaction test principle | Immunoturbidimetric | ELISA/1-step sandwich assay with streptavidin technology |
| Instrument required | Hitachi | ES 300 |
| Calibration | NIBSC standard 80/602 and | |
| 80/578 (human liver and spleen) | NIBSC standard 80/602 | |
| (human liver) |
Performance Characteristics:
| Feature | Tina-quant® Ferritin | Enzymun-Test® Ferritin | ||||
|---|---|---|---|---|---|---|
| Precision | Intra and InterAssay (ng/mL): | Modified NCCLS (ng/mL): | ||||
| Level | Low | Mid | High | Low | Mid | High |
| N | 21 | 21 | 21 | 120 | 120 | 120 |
| Intra-Assay Mean | 31.9 | 144.4 | 645.1 | 10.4 | 368.8 | 821.5 |
| %CV | 3.8 | 1.4 | 1.1 | 6.2 | 2.7 | 2.5 |
| Level | Sample 1 | Sample 2 | ||||
| Inter-Assay Mean | 76.4 | 347.4 | 10.4 | 368.8 | 821.5 | |
| %CV | 2.6 | 2.2 | 6.4 | 4.3 | 4.9 |
Continued on next page
5
BOEHRINGEN 10(k) Summary, Continued 1000 CORPORATION
Image /page/5/Picture/1 description: The image is a low-resolution, black and white photograph. The left side of the image has some text, but it is unreadable due to the image quality. The rest of the image is mostly black, with some lighter areas that could be interpreted as objects or shapes.
Performance Characteristics:
Comparison to predicate
device, (cont.)
| Feature | Tina-quant® Ferritin | Enzymun-Test® Ferritin |
|---|---|---|
| Lower Detection | ||
| Limit | 3 ng/mL | 1.0 ng/mL |
| Linearity | 3 - 800 ng/mL | 1.0 - 1000 ng/mL |
| Method | ||
| Comparison | Vs Enzymun-Test® Ferritin | |
| Passing/Bablok | ||
| $y=1.04x + 4.8$ $r=0.996$ $SEE =13.68$ $N=44$ | Vs Enzymun-Test® Ferritin | |
| Passing/Bablok | ||
| $y=1.15x - 2.8$ $r=0.992$ $SEE =44.9$ $N=56$ | ||
| Least Squares: | ||
| $y = 1.00x + 13.1$ $r = 0.997$ $SEE = 13.52$ $N = 44$ |
Continued on next page
6
HRINGER10(k) Summary, Continued 20 1 CORPORATION
Image /page/6/Picture/1 description: The image shows a black and white photograph. The left side of the image has a vertical column of text that is unreadable. The rest of the image is black.
Acres
Comparison
to predicate
device, (cont.)
Performance Characteristics:
| Feature | Tina-quant® Ferritin | Enzymun-Test® Ferritin |
|---|---|---|
| Interfering | ||
| substances | No interference at: | |
| (≤ 10% error) | No interference at: | |
| (≤ 10% error) | ||
| Bilirubin | ||
| Hemoglobin | ||
| Lipemia | 68 mg/dL | |
| 500 mg/dL | ||
| 1500 mg/dL | 64.5 mg/dL | |
| 1 g/dL | ||
| 1250 mg/dL | ||
| Rheumatoid | ||
| Factor | 100 IU/mL | N/A |
| Specificity | Liver Ferritin 114.6% | |
| Spleen Ferritin 112.0% | ||
| Heart Ferritin 1.7% | Liver Ferritin 100% | |
| Spleen Ferritin 89% |
7
510(k) Number (if known):
Device Name: Tinaquant Ferritin Assay
Indications For Use:
Immunological.in. vitro immunoturbidometric.test for the quantitative determination of ferritin.in . .... human serum and plasma using clinical-chemistry analyzers.
A variety of methods are available for determing ferritin, e.g. radio-immunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA)luminescence immunoassay (LIA) and nephelometric immunoassay.
The assay is unaffected by icterus (bilirubin up to 60 mg/dl), hemolysis (Hb