(82 days)
No
The summary describes a standard turbidimetric immunoassay for quantitative determination of ferritin, with no mention of AI or ML terms, image processing, or data training/testing sets.
No.
This device is an in vitro diagnostic (IVD) product used to quantitatively determine ferritin levels, which aids in diagnosis and monitoring, but does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay." This type of quantitative measurement of a biomarker in human samples is characteristic of a diagnostic device, as it provides information used to aid in the diagnosis, monitoring, or treatment of diseases.
No
The device description clearly states it is a reagent and calibrator, which are physical components used in a turbidimetric immunoassay on an immunochemistry system. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay." This describes a test performed on a sample taken from the human body (serum) to provide information about a medical condition (ferritin levels).
- Device Description: The description reinforces that the reagents and calibrator are for the "quantitative determination of Ferritin in serum."
- Performance Studies: The performance studies detail method comparison and imprecision experiments, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability in measuring analytes in biological samples.
- Predicate Device: The mention of a "Predicate Device" (IMx®* Ferritin (FER)) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device to demonstrate substantial equivalence.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.
Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.
Product codes
DBF
Device Description
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.
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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments.
Method Comparison Study Results:
Analyte: IMMAGE FER Reagent
Sample Type: serum
Slope: 1.059
Intercept (ng/mL): -6.5
r: 0.987
n: 116
Predicate Method: IMx Ferritin
Estimated IMMAGE System Ferritin (FER) Reagent Imprecision:
Within-Run Imprecision
Sample: Level 1, Mean (ng/mL): 53.5, S.D. (ng/mL): 2.4, %C.V.: 4.4, N: 80
Sample: Level 2, Mean (ng/mL): 172.0, S.D. (ng/mL): 5.3, %C.V.: 3.0, N: 80
Sample: Level 3, Mean (ng/mL): 397.0, S.D. (ng/mL): 10.5, %C.V.: 2.6, N: 80
Total Imprecision
Sample: Level 1, Mean (ng/mL): 53.5, S.D. (ng/mL): 2.9, %C.V.: 5.5, N: 80
Sample: Level 2, Mean (ng/mL): 172.0, S.D. (ng/mL): 7.1, %C.V.: 4.1, N: 80
Sample: Level 3, Mean (ng/mL): 397.0, S.D. (ng/mL): 12.4, %C.V.: 3.1, N: 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
DEC | 4 1998
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized symbol on the left and the company name "BECKMAN COULTER" on the right. The symbol appears to be two curved shapes intertwined, and the text is in a bold, sans-serif font.
Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Ferritin Reagent
1.0 Submitted By:
Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
2.0 Date Submitted:
21 September 1998
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE® Immunochemistry System Femitin (FER) Reagent IMMAGE® Immunochemistry System Ferritin Calibrator
Classification Name 3.2
Ferritin Test System (21 CFR §862.3920) Catibrator (21 CFR 5882.1150)
4.0 Predicate Device(s):
| IMMAGE System | Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| IMMAGE System Ferritin | |||
| (FER) Reagent | IMx®* Ferritin (FER) | Abbott** | |
| Laboratories, Inc | K881345 | ||
| IMMAGE System Ferritin | |||
| Calibrator | (K882233) | ||
| DIGOXAL |
*Trademark of Abbott Laboratories
** Abbott Laboratories, Abbott Park, IL 60064
5.0 Description:
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.
6.0 Intended Use:
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® with Immunochemistry System Ferritin Calibrator, is intended for the quantitative determination of femitin in human serum by turbidimetric immunoassay.
Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE Immunochemistry Systems for the calibration of ferritin.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
| IMMAGE System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System FER | Intended use. | |
| Reagent | Reaction temperature of 37° C | Same as Abbott |
| IMMAGE System FER | Human Spleen Origin | IMx Ferritin |
| Calibrator | Calibrator linked to a WHO Standard |
SIMILARITIES to the PREDICATE
DIFFERENCES from the PREDICATE
| IMMAGE
| System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE | ||
| System FER | ||
| Reagent | IMMAGE FER uses Near Infrared | |
| Particle Immunoassay (NIPIA) rate | ||
| immunoassay methodology | Abbott IMx reagents utilize | |
| fluorescence polarization | ||
| immunoassay | ||
| Antibody source for IMMAGE FER is | ||
| rabbit (polyclonal) | Antiserum sources for IMx | |
| Ferritin are rabbit and mouse | ||
| IMMAGE | ||
| System FER | ||
| Calibrator | Calibration | IMMAGE FER uses a single |
| point calibration while IMx is | ||
| multipoint | ||
| IMMAGE | ||
| System FER | ||
| Sample | IMMAGE System FER requires a | |
| sample volume of 7.5 µL | IMx ferritin requires a sample | |
| volume of 150µL |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments.
| Analyte | Sample Type | Slope | Intercept (ng/mL) | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| FER Reagent | serum | 1.059 | -6.5 | 0.987 | 116 | IMx Ferritin |
Method Comparison Study Results
Estimated IMMAGE System Ferritin (FER) Reagent Imprecision
| Sample | Mean (ng/mL) | S.D. (ng/mL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 53.5 | 2.4 | 4.4 | 80 |
| Level 2 | 172.0 | 5.3 | 3.0 | 80 |
| Level 3 | 397.0 | 10.5 | 2.6 | 80 |
| Total Imprecision | ||||
| Level 1 | 53.5 | 2.9 | 5.5 | 80 |
| Level 2 | 172.0 | 7.1 | 4.1 | 80 |
| Level 3 | 397.0 | 12.4 | 3.1 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
2098 Gaither Road
Rockville MD 20850
Food and Drug Administration
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEC | 4 1998 Mr. Richard T. Ross Staff Requlatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000
Re : K983340
IMMAGE® Immunochemistry System Ferritin (FER) Trade Name: Reagent and IMMAGE® Immunochemistry System Ferritin Calibrator Requlatory Class: II Product Code: DBF Dated: September 21, 1998 September 23, 1998 Received:
Dear Mr. Ross:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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.
3
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 (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
page 1 of $\overline{J}$
510(k) Number (if known): Not yet assigned-
Device Name:
IMMAGE® Immunochemistry System Ferritin (FER) Reagent
Indications for Use:
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.
Clinical Significance:
Ferritin is the main iron storage protein in the body. The concentration of ferritin is directly proportional to the iron stores in the body. Measurement of ferritin may aid in the diagnosis of anemia and hemochromatosis (Iron overload).
Ferritin (21 CFR §866.5340)
(b) Classification. Class II.
(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 | K983348 |
| Prescription Use
(per 21 CFR 801.109) | | OR | Over-the-Counter Use
Optional Format 1-2-96 |
| ------------------------------------------ | ------------------------------------ | ---- | ------------------------------------------------ |
|---|
5
page 2 of 2
510(k) Number (if known):- Not yet assigned
Device Name:
IMMAGE® Immunochemistry Systems Ferritin Calibrator
Indications for Use:
Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.
Clinical Significance:
Ferritin is the main iron storage protein in the body. The concentration of ferritin is directly proportional to the iron stores in the body. Measurement of ferritin may aid in the diagnosis of anemia and hemochromatosis (Iron overload).
Calibrator (21 CFR §862.1150)
(b) Classification. Class II.
(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
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96