(50 days)
Not Found
No
The description details a standard immunoturbidimetric assay based on chemical reactions and light absorbance measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic reagent system used for quantitative immunological determination of human ferritin, aiding in the diagnosis of diseases. It does not directly treat or alleviate a disease, but rather provides diagnostic information.
Yes
The "Intended Use / Indications for Use" section explicitly states that this is an "In vitro diagnostic reagent system" and that "Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism." This directly indicates its role in diagnosis.
No
The device description clearly outlines a particle enhanced immunoturbidimetric assay, which is a laboratory test involving physical reagents and a turbidimeter (hardware) to measure light absorbance. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "In vitro diagnostic reagent system".
- Purpose: It is designed for the "quantitative immunological determination of human ferritin in serum and plasma," which are biological samples taken from the body.
- Clinical Application: The measurements aid in the "diagnosis of diseases affecting iron metabolism," indicating a clinical purpose for the test results.
- Device Description: The description details a laboratory assay performed on a biological sample (serum and plasma) to measure a specific analyte (ferritin).
All these points align 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
In vitro diagnostic reagent system intended for use on COBAS Integra system for the quantitative immunological determination of human ferritin in serum and plasma.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia.
Product codes
DBF
Device Description
A particle enhanced immunoturbidimetric assay in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 552 nm.
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:
Within run CV
9.0% @ 19.8 ng/ml
2.5% @ 107.5 ng/ml
Between Day CV
7.8% @ 20.3 ng/ml
3.4% @ 157.0 ng/ml
Method Comparison:
Bablok/Passing:
Ferritin Generation 2 (Y) / COBAS Integra Ferritin (X).
y = 1.30x + 12.98 ng/ml
r = 0.922
Limitations:
• Icterus: No significant interference
• Hemolysis: No significant interference up to a level 596 µmol/l.
• Lipemia: No significant interference up to an Intralipid level of 160 mg/dL
• Rheumatoid factors: No significant interference
Prozone Effect:
No effect up to 10,000 ng/ml
Analytical sensitivity (LDL):
7.5 ng/ml
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K03/650
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. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
(317) 521 - 3544 |
| | Contact Person: Kay A. Taylor |
| | Date Prepared: May 27, 2003 |
| Device Name | Proprietary name: Ferritin Generation 2 |
| | Common name: Ferritin |
| | Classification name: Ferritin, Antigen, Antiserum, Control |
| Device
Description | A particle enhanced immunoturbidimetric assay in which human ferritin
agglutinates with latex particles coated with anti-ferritin antibodies. The
precipitate is determined turbidimetrically at 552 nm. |
| Intended use | In vitro diagnostic reagent system intended for use on COBAS Integra system
for the quantitative immunological determination of human ferritin in serum
and plasma. |
| Indications for
Use | Measurements of ferritin aid in the diagnosis of diseases affecting iron
metabolism such as hemochromatosis (iron overload) and iron deficiency
anemia. |
| Substantial
Equivalence | The Ferritin Generation 2 is substantially equivalent to other devices legally
marketed in the United States. We claim equivalence to the COBAS Integra
Ferritin assay (K963292). Both products are intended for use in the
quantitative determination of Ferritin on automated clinical chemistry
analyzers. |
:
and the control of the comments of the control of
1
510(k) Summary, Continued
Substantial equivalence similarities
The following table compares the Ferritin Generation 2 Assay with the predicate device.
| Feature | Ferritin Generation 2 | Ferritin
(predicate) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent
system intended for use on
COBAS INTEGRA system
for the quantitative
immunological
determination of human
ferritin in serum and plasma. | In vitro diagnostic reagent
system intended for use on
COBAS INTEGRA system
for the quantitative
immunological determination
of human ferritin in serum
and plasma. |
| Indication for Use | For the quantitative
determination of ferritin in
human serum and plasma.
Measurements of ferritin aid
in the diagnosis of diseases
affecting iron metabolism
such as hemochromatosis
(iron overload) and iron
deficiency anemia. | For the quantitative
determination of ferritin in
human serum and plasma.
Measurements of ferritin aid
in the diagnosis of diseases
affecting iron metabolism
such as hemochromatosis
(iron overload) and iron
deficiency anemia. |
| Assay Protocol | Particle enhanced
Immunoturbidometric | Particle enhanced
Immunoturbidometric |
| Instrument | COBAS Integra Clinical
Chemistry Analyzers | COBAS Integra Clinical
Chemistry Analyzers |
| Sample Type | Serum and plasma | Serum and plasma |
| Formulation | R: Glycine buffer stabilized
with 0.09% sodium azide,
5mg/ml rabbit globulin in
vial B (liquid).
R2: Latex particles coated
with anti-human ferritin
(rabbit) in glycine buffer,
stabilized with 0.09%
sodium azide in vial C
(liquid). | R: Glycine buffer stabilized
with 0.09% sodium azide in
vial B (liquid).
R2: Latex particles coated
with anti-human ferritin
(rabbit) in glycine buffer,
stabilized with 0.09% sodium
azide in vial C (liquid). |
| Calibrator | FERR T Standard | FERR T Standard |
| Controls | FERR /MYO T Control | FERR /MYO T Control |
| Reagent Stability | On board: 12 weeks | On-board: 12 weeks |
| Feature | Ferritin Generation 2 | Ferritin
(predicate) |
| Expected Values | Females: 15-150 ng/ml
Males: 30-400 ng/ml
(3 mos-16 yrs):
20-200 ng/ml
(2nd-3rd month):
80-500 ng/ml
(1st month):
150-400 ng/ml
(umbilical cord blood):
50-250 ng/ml | Females: 10-120 ng/ml
Males: 20-300 ng/ml |
| Measuring Range | 0-382 ng/ml | Integra 400: 0-280 ng/ml
Integra 700: 0-300 ng/ml |
| Traceability /
Standardization | Standardized against the
NIBSC Reagents for Ferritin
(human spleen 80/578). | Traceable to WHO
Reference Preparation for
Human Liver Ferritin (1st
International Standard 1984) |
| Calibration Interval | After each lot and 84 days | After each lot |
23
2
510(k) Summary, Continued
Substantial equivalence differences
The following table compares the Ferritin Generation 2 Assay with the predicate device.
3
510(k) Summary, Continued
Substantial equivalence performance characteristics The performance characteristics of the Ferritin Generation 2 Assay and the predicate device are compared in the table below.
| Feature | Ferritin Generation 2 | Apolipoprotein B
(predicate) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV
9.0% @ 19.8 ng/ml
2.5% @ 107.5 ng/ml
Between Day CV
7.8% @ 20.3 ng/ml
3.4% @ 157.0 ng/ml | Within run CV
9.9% @ 19 ng/ml
1.2% @ 260 ng/ml
Between Day CV
10.2% @ 19 ng/ml
3.8% @ 260 ng/ml |
| Method Comparison | Bablok/Passing:
Ferritin Generation 2 (Y) /
COBAS Integra Ferritin (X).
$y = 1.30x + 12.98$ ng/ml
$r = 0.922$ | Bablok/Passing:
Ferritin (Y)/
commercially available
system (X).
$y = 0.84x + 0.8$ ng/ml
$r = 0.992$ |
| Limitations | • Icterus: No significant
interference
• Hemolysis: No
significant interference
up to a level 596 µmol/l.
• Lipemia: No significant
interference up to an
Intralipid level of 160
mg/dL
• Rheumatoid factors: No
significant interference | • Icterus: No significant
interference
• Hemolysis: No
significant
interference
• Lipemia: No
significant
interference
• Rheumatoid factors:
No significant
interference |
| Prozone Effect | No effect up to 10,000 ng/ml | Integra 400/400 plus:
No effect up to 4300 ng/ml
Integra 700 /800:
No effect up to 45,000
ng/ml |
| Analytical sensitivity
(LDL) | 7.5 ng/ml | 5 ng/ml |
:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis. Indiana 46250-0457
JUL 17 2003
Re: K031650
Trade/Device Name: Roche COBAS Integra Ferritin Generation 2 Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF Dated: July 7, 2003 Received: July 9, 2003
Dear Ms. Taylor:
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. Drue, 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
5
Page 2 --
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Ferritin Generation 2 Test System
Indications For Use:
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
J. Reeve for J. Bautista
Division Sign-Off
Division Sign-Off
ice of In Vitro Diagnostic Evaluation and
510(k) K031650
20