(71 days)
None
No
The summary describes a standard chemiluminescence immunoassay for ferritin and does not mention any AI or ML components in the device description, performance studies, or other sections.
No
The device is used for the quantitative determination of ferritin to aid in the diagnosis of certain conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended to aid in the diagnosis of iron deficiency anemia and iron overload."
No
The device description clearly states it is a "two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System," indicating it is a laboratory assay kit that requires specific hardware (the Nichols Advantage® Specialty System) to function, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is designed for the "quantitative determination of ferritin in human serum or plasma." This is a test performed on biological samples taken from the body.
- Purpose: The intended use also states that the assay is "intended to aid in the diagnosis of iron deficiency anemia and iron overload." This indicates that the results of the test are used for medical diagnostic purposes.
- Device Description: The description mentions it's a "two-site chemiluminescence assay," which is a common method used in laboratory testing of biological samples.
These points clearly align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Nichols Advantage® Chcmiluminescence Ferritin Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma.
The Nichols Advantage® Chemiluminescence Ferritin Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma. This assay is intended to aid in the diagnosis of iron deficiency anemia and iron overload.
Product codes
DBF
Device Description
The Nichols Advantage® Ferritin Assay is a two-site chcmiluminescence assay for use with the Nichols Advantage® Specialty System
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)
Intra-Assay
- Mean (ng/mL): 16, n: 20, %CV: 4.6
- Mean (ng/mL): 48, n: 20, %CV: 3.9
- Mean (ng/mL): 159, n: 20, %CV: 4.4
- Mean (ng/mL): 437, n: 20, %CV: 4.9
Inter-Assay
- Mean (ng/mL): 19, n: 20, %CV: 12.2
- Mean (ng/mL): 47, n: 20, %CV: 7.2
- Mean (ng/mL): 153, n: 20, %CV: 6.3
- Mean (ng/mL): 372, n: 20, %CV: 5.9
Recovery
- 94 - 104
Parallelism
- 99 - 114
High Dose Hook Effect
- Greater than 16,000 ng/mL
Specificity and Cross-Reactivity
- Spleen Ferritin: 100%
- Liver Ferritin: 100%
Method Comparison
- Range of Results: 2.3 ng/mL to 608 ng/mL
- Linear Regression Equation: y = 0.94x - 4.7 ng/mL
- Correlation Coefficient (r): 0.98
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 2 ng/mL in serum or plasma
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
FEB 2 1999
Nichols Institute Diagnostics Nichols Advantage® Ferritin 510(k) Notification
11.0 510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | not known | K984186 |
|---|---|---|
| ---------------- | ----------- | --------- |
1. Name of Submitter, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675-4703 Phone: 949-240-5260 Fax: 949-240-5313
Contact Person: Jimmy Wong Date Prepared: November 20, 1998
2. Device Name
| Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Ferritin
Immunoassay |
|-------------------------|--------------------------------------------------------------|
| Common/Usual Name: | Ferritin Assay |
| Classification Name: | Ferritin Immunological Test System |
3. Predicate Device:
We claim substantial equivalence to the Chiron Diagnostics ACS:/80° Automated. We claim substantial +C Assay (K905770, Cleared March 12, 1991).
4. Device Description:
The Nichols Advantage® Ferritin Assay is a two-site chcmiluminescence assay for use with the Nichols Advantage® Specialty System
Page 29 of 57
1
5. Intended Use
The Nichols Advantage® Chcmiluminescence Ferritin Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma.
6. Comparison to predicate device:
The Nichols Advantage® Ferritin Assay is substantially equivalent to other products in commercial distribution for similar use. Most notably, it is substantially equivalent to the Chiron Diagnostics ACS:180 Ferritin Immunoassay.
The following tables compare the Nichols Advantage Ferritin Assay with the predicate device, Chiron Diagnostics ACS:180 Ferritin Immunoassay .
Similarities:
- Intended Use: For the quantitative determination of ferritin in human serum or plasma ● (Nichols Advantage Ferritin Assay); in serum (Chiron Diagnostics ACS:180 Ferritin Immunoassay).
- Both assays use specific antibodies to bind ferritin. ●
- Both assays use human serum for the test sample. ●
- Both assays use chemiluminometric technology based on acridinium esters. .
- The sensitivity of both assays is sufficient to measure ferritin levels found in normal, . iron deficient and iron overload patients.
| Feature | Nichols Advantage®
Ferritin | ACS:180® Automated
Chemiluminescence
System Ferritin +C
Assay |
|-------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Size | 150 microliters | 25 microliters |
| Calibration | Two point calibration every two
weeks (maximum) of stored
working calibration curve; or
when controls out of range. | Two point calibration every
15 days of stored working
calibration curve; or when
controls out of range. |
| Solid Phase | Streptavidin-coated magnetic
particles. Streptavidin-biotin
separation technology. | Mouse monoclonal anti-ferritin
antibodies covalently coupled
to paramagnetic particles.
Antibody sandwich-formation
separation technology. |
| Incubation | 30 minutes at 37°C | 7.5 minutes at 37°C |
| Sensitivity | 2 ng/mL in serum or plasma | 0.5 ng/mL in serum |
Differences:
2
Image /page/2/Picture/0 description: The image is a black and white graphic. The graphic appears to be a silhouette of a land mass. The land mass is irregularly shaped and has a jagged coastline. The image is simple and lacks detail.
Nichols Institute Diagnostics
Nichols Advantage® Ferritin 510(k) Notification
Performance Characteristics:
.
..............................................................................................................................................................................
| FEATURE | Nichols Advantage®
Chemiluminescence Ferritin | | | Chiron Diagnostics ACS:180®
Ferritin +C Assay | | |
|--------------------------------------|--------------------------------------------------|----|------|--------------------------------------------------|----|-----|
| Intra-Assay | Mean
(ng/mL) | n | %CV | Mean
(ng/mL) | n | %CV |
| | 16 | 20 | 4.6 | 13 | 24 | 2.8 |
| | 48 | 20 | 3.9 | 55 | 24 | 2.8 |
| | 159 | 20 | 4.4 | 163 | 24 | 2.7 |
| | 437 | 20 | 4.9 | 360 | 24 | 3.6 |
| Inter-Assay | Mean
(ng/mL) | n | %CV | Mean
(ng/mL) | n | %CV |
| | 19 | 20 | 12.2 | 13 | 8 | 5.0 |
| | 47 | 20 | 7.2 | 55 | 8 | 6.1 |
| | 153 | 20 | 6.3 | 163 | 8 | 4.9 |
| | 372 | 20 | 5.9 | 360 | 8 | 5.1 |
| Recovery | 94 - 104 | | | 93 - 112 | | |
| Parallelism | 99 - 114 | | | 92 - 112 | | |
| High Dose Hook Effect | Greater than 16,000 ng/mL | | | 80,000 ng/mL | | |
| Specificity and
Cross-Reactivity: | | | | | | |
| Spleen Ferritin | 100% | | | Not Determined | | |
| Liver Ferritin | 100% | | | 106% | | |
| Method Comparison | | | | | | |
| Range of Results | 2.3 ng/mL to 608 ng/mL | | | 7.0 ng/mL to 663 ng/mL | | |
| Linear Regression Equation | $y = 0.94x - 4.7 ng/mL$ | | | | | |
| Correlation Coefficient (r) | 0.98 | | | | | |
| | | | | | | |
| | | | | | | |
Page 31 of 57
3
2 1999 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jimmy Wong Manager, Clinical and Technical Affairs NICHOLS INSTITUTE DIAGNOSTICS 33051 Calle Aviador San Juan Capistrano, CA 92675-4703
Re: K984186 Trade Name: Nichols Advantage® Chemiluminescence Ferritin Immunoassay Regulatory Class: II Product Code: DBF November 20, 1998 Dated: November 23, 1998 Received:
Dear Mr. Wong:
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 The general controls provisions of the provisions of the Act. 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 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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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.
4
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K984186
Device Name: Nichols Advantage® Chemiluminescence Ferritin Immunoassay
Indications For Use:
The Nichols Advantage® Chemiluminescence Ferritin Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma. This assay is intended to aid in the diagnosis of iron deficiency anemia and iron overload.
Peter E. Mayeri
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)