(90 days)
Not Found
No
The summary describes a standard immunoassay for measuring ferritin levels and does not mention any AI or ML components. The performance studies are based on traditional statistical methods for assay validation.
No.
The device is an in vitro diagnostic (IVD) assay designed to quantify ferritin levels to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload," clearly indicating its diagnostic purpose.
No
The device is an in vitro diagnostic (IVD) assay that includes reagent packs and calibrators, which are physical components, and is designed for use with a specific hardware analyzer (Dxl 9000 Access Immunoassay Analyzer). It is not solely software.
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 for the "quantitative determination of ferritin levels in human serum and plasma (heparin)". This indicates that the test is performed on samples taken from the human body.
- Purpose: The intended use also states that the results are "used as an aid in the diagnosis of iron deficiency or iron overload." This clearly indicates a diagnostic purpose.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and mentions components like "reagent pack and calibrators," which are typical of in vitro diagnostic tests.
- Care Setting: The device is designed for use "in a clinical laboratory setting," which is where IVD tests are typically performed.
- Performance Studies: The document describes various performance studies (Method Comparison, Precision, Linearity, LoB, LoD, LoQ) conducted on human samples (serum and plasma), which are standard for validating IVD performance.
- Predicate Device: The mention of "Predicate Device(s)" with K numbers (K926221, K052082; Access Ferritin) further confirms that this device is being compared to previously cleared IVD devices.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
Product codes (comma separated list FDA assigned to the subject device)
JMG
Device Description
The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Ferritin assay reagent pack, Access Ferritin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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. However, it indicates "clinical laboratory setting"
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)
Method Comparison: A method comparison study was performed to compare the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred forty-seven (147) samples falling within the measuring range of the Access Ferritin assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.09.
Precision: The assay was designed to have within-laboratory imprecision as listed below:
≤ 0.5 ng/mL (µg/L) SD at concentrations ≤ 5 ng/mL (µg/L)
≤ 10.0% CV at concentrations > 5 ng/mL (ug/L)
A study based on CLSI EP05-A317 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
Linearity: A verification study was performed to evaluate the linearity of the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The Access Ferritin assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 0.6-1,500 ng/mL
Limit of Blank (LoB): In one study, LoB was tested using a protocol based on CLSI EP17-A2. A total of 75 replicates of native samples were measured using two reagent packs on two Dxl 9000 Access Immunoassay Analyzers. The claimed LoB for Access Ferritin assay is 0.2 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD); In one study, LoD was tested using a protocol based on CLSI EP17-A2. Three Dxl 9000 Access Immunoassay Analyzers were used in the study design with three reagent lots and one calibrator lot. Five to nine serum samples containing low levels of Ferritin analyte were prepared. Samples were tested over five days with one run per day and nine replicates per run for each pack lot. This resulted in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested. The claimed LoD estimate for the Access Ferritin assay is 0.4 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): In one study, LoQ was tested using a protocol based on CLSI EP17-A2. For estimation of LoQ, eight to twelve serum samples containing low levels of Ferritin analyte were measured. Samples were tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument. A minimum of 40 replicates for each sample on each pack lot was tested.The maximum claimed LoQ ((≤ 20% within-lab CV) determined for the Access Ferritin assay is 0.6 ng/mL on Dxl 9000 Access Immunoassay Analyzer).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method Comparison:
N: 147
Concentration Range*: 2.3-1471 (ng/mL[ug/L])
Slope: 0.96
Slope 95% Cl: 0.95-0.97
Intercept: 0.23
Intercept 95% Cl: -0.34-1.1
R: 0.99
*Range is Access 2 values
Precision:
Sample 1 (Mean 1.2 ng/mL[ug/L]): Repeatability SD 0.2, Repeatability %CV 16.5; Between-run SD 0.0, Between-run %CV 0.0; Between-day SD 0.1, Between-day %CV 5.3; Within-Laboratory SD 0.2, Within-Laboratory %CV 17.3
Sample 2 (Mean 13 ng/mL[ug/L]): Repeatability SD 0.4, Repeatability %CV 3.1; Between-run SD 0.2, Between-run %CV 1.3; Between-day SD 0.4, Between-day %CV 3.2; Within-Laboratory SD 0.6, Within-Laboratory %CV 4.7
Sample 3 (Mean 147 ng/mL[ug/L]): Repeatability SD 4.5, Repeatability %CV 3.0; Between-run SD 2.0, Between-run %CV 1.4; Between-day SD 6.0, Between-day %CV 4.1; Within-Laboratory SD 7.7, Within-Laboratory %CV 5.3
Sample 4 (Mean 289 ng/mL[ug/L]): Repeatability SD 8.6, Repeatability %CV 3.0; Between-run SD 0.0, Between-run %CV 0.0; Between-day SD 9.1, Between-day %CV 3.1; Within-Laboratory SD 12.5, Within-Laboratory %CV 4.3
Sample 5 (Mean 560 ng/mL[ug/L]): Repeatability SD 17.2, Repeatability %CV 3.1; Between-run SD 10.0, Between-run %CV 1.8; Between-day SD 16.2, Between-day %CV 2.9; Within-Laboratory SD 25.7, Within-Laboratory %CV 4.6
Sample 6 (Mean 1276 ng/mL[ug/L]): Repeatability SD 53.3, Repeatability %CV 4.2; Between-run SD 5.8, Between-run %CV 0.5; Between-day SD 42.2, Between-day %CV 3.3; Within-Laboratory SD 68.2, Within-Laboratory %CV 5.3
Limit of Blank: 0.2 ng/mL
Limit of Detection: 0.4 ng/mL
Limit of Quantitation: 0.6 ng/mL
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 20, 2024
Beckman Coulter, Inc Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K234052
Trade/Device Name: Access Ferritin Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: JMG Dated: December 21, 2023 Received: December 21, 2023
Dear Kate Oelberg:
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, Drug, and Cosmetic Act (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K234052
Device Name Access Ferritin
Indications for Use (Describe)
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510 (k) Summary
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.
510(k) Number___________K234052____________
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg, Senior Staff Quality and Regulatory Affairs Email: kmoelberg@beckman.com Phone: (612) 431-7315
Alternate Contact:
Kuljeet Kaur, Requlatory Affairs Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914
Trade Name: Access Ferritin Common Name: Ferritin Classification Regulation: 21 CFR 866.5340 Classification Product Code: JMG
Predicate Device:
Access Ferritin 510(k) Number K926221, K052082
Device Description
The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Ferritin assay reagent pack, Access Ferritin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Intended Use
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
4
Comparison of Technological Characteristics to the Predicate (Assay)
| System
Attribute/Characteristic | Predicate Access Ferritin
assay (K926221/ K052082)
run on the Access
Immunoassay System | Access Ferritin assay run on
the Dxl 9000 Access
Immunoassay Analyzer
Instrument |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The Access Ferritin assay is a
paramagnetic particle,
chemiluminescent
immunoassay for the
quantitative determination
of ferritin levels in human
serum and plasma (heparin)
using the Access
Immunoassay Systems. | The Access Ferritin assay is a
paramagnetic particle,
chemiluminescent immunoassay
for the quantitative determination
of ferritin levels in human serum
and plasma (heparin) using the
Access Immunoassay Systems.
Ferritin is used as an aid in the
diagnosis of iron deficiency or
iron overload. |
| Analyte Measured | Ferritin | Same |
| Traceable to | WHO 94/572 | Same |
| Technology | Sandwich Immunoassay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration
curve | Same |
| Sample Type | Serum/Plasma | Same |
| Stability | 28 days after opening | Same |
| Reagent Pack
formulation and
packaging | Access Reagent Pack
formulation and packaging. | Same |
| Reagent Configurations | One Configuration:
100 determinations, 2 packs,
50 tests/pack | Two Configurations:
- 100 determinations, 2
packs, 50 tests/pack (for
predicate and candidate
instrument) - 200 determinations, 2
packs, 100 tests/pack (for
candidate instrument only) |
| Measuring Range | 0.2-1,500 ng/mL
Dil-Fer range
1,500-15,000 ng/mL | 0.6-1,500 ng/mL
Automated dilution: Up to
approximately 75,000 ng/mL
(µg/L) |
| Sample Volume | 10 uL | 5 uL |
| Instrument | Access Immunoassay system | Dxl 9000 Access
Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO substrate |
5
Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition
CLSI EP06-2nd Edition : Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples-Third Edition
Summarv of Studies:
Method Comparison: A method comparison study was performed to compare the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred forty-seven (147) samples falling within the measuring range of the Access Ferritin assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.09.
| N | Concentration
Range*
(ng/mL[ug/L]) | Slope | Slope
95% Cl | Intercept | Intercept
95% Cl | R |
|-----|------------------------------------------|-------|-----------------|-----------|---------------------|------|
| 147 | 2.3-1471 | 0.96 | 0.95-0.97 | 0.23 | -0.34-1.1 | 0.99 |
*Range is Access 2 values
Precision: The assay was designed to have within-laboratory imprecision as listed below:
≤ 0.5 ng/mL (µg/L) SD at concentrations ≤ 5 ng/mL (µg/L)
≤ 10.0% CV at concentrations > 5 ng/mL (ug/L)
A study based on CLSI EP05-A317 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
| Concentration (ng/mL[ug/L]) | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within-
Laboratory
(Total) | | |
|-----------------------------|----|-------------------------------|------|-------------|------|-------------|------|----------------------------------|------|------|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| SAMPLE 1 | 80 | 1.2 | 0.2 | 16.5 | 0.0 | 0.0 | 0.1 | 5.3 | 0.2 | 17.3 |
| SAMPLE 2 | 80 | 13 | 0.4 | 3.1 | 0.2 | 1.3 | 0.4 | 3.2 | 0.6 | 4.7 |
| SAMPLE 3 | 80 | 147 | 4.5 | 3.0 | 2.0 | 1.4 | 6.0 | 4.1 | 7.7 | 5.3 |
| SAMPLE 4 | 80 | 289 | 8.6 | 3.0 | 0.0 | 0.0 | 9.1 | 3.1 | 12.5 | 4.3 |
| SAMPLE 5 | 80 | 560 | 17.2 | 3.1 | 10.0 | 1.8 | 16.2 | 2.9 | 25.7 | 4.6 |
| SAMPLE 6 | 80 | 1276 | 53.3 | 4.2 | 5.8 | 0.5 | 42.2 | 3.3 | 68.2 | 5.3 |
Linearity: A verification study was performed to evaluate the linearity of the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The Access Ferritin assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 0.6-1,500 ng/mL
Limit of Blank (LoB): In one study, LoB was tested using a protocol based on CLSI EP17-A2. A total of 75 replicates of native samples were measured using two reagent packs on two Dxl 9000 Access Immunoassay Analyzers. The claimed LoB for Access Ferritin assay is 0.2 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
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Limit of Detection (LoD); In one study, LoD was tested using a protocol based on CLSI EP17-A2. Three Dxl 9000 Access Immunoassay Analyzers were used in the study design with three reagent lots and one calibrator lot. Five to nine serum samples containing low levels of Ferritin analyte were prepared. Samples were tested over five days with one run per day and nine replicates per run for each pack lot. This resulted in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested. The claimed LoD estimate for the Access Ferritin assay is 0.4 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): In one study, LoQ was tested using a protocol based on CLSI EP17-A2. For estimation of LoQ, eight to twelve serum samples containing low levels of Ferritin analyte were measured. Samples were tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument. A minimum of 40 replicates for each sample on each pack lot was tested.The maximum claimed LoQ ((≤ 20% within-lab CV) determined for the Access Ferritin assay is 0.6 ng/mL on Dxl 9000 Access Immunoassay Analyzer).
Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are being transferred from file K926221.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to Ferritin assay on the Access Immunoassay System (K926221) as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.