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.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Device Name: Access Ferritin

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Design Goal)	Reported Device Performance
Method Comparison
R²	≥ 0.90	0.99
Slope	1.00 ± 0.09	0.96 (95% CI: 0.95-0.97)
Intercept	Not explicitly stated as a numerical acceptance criterion, but implied to be near zero.	0.23 (95% CI: -0.34-1.1)
Precision (Within-Laboratory Imprecision)
Concentrations ≤ 5 ng/mL (µg/L)	≤ 0.5 ng/mL (µg/L) SD	Sample 1 (1.2 ng/mL): 0.2 ng/mL SD (17.3% CV). Note: While the SD (0.2) is below 0.5, the CV (17.3%) is high. The acceptance criterion is specifically for SD, so it meets the criterion numerically, but the CV suggests variability at this low concentration.
Concentrations > 5 ng/mL (µg/L)	≤ 10.0% CV	Sample 2 (13 ng/mL): 4.7% CV Sample 3 (147 ng/mL): 5.3% CV Sample 4 (289 ng/mL): 4.3% CV Sample 5 (560 ng/mL): 4.6% CV Sample 6 (1276 ng/mL): 5.3% CV (All samples well within the 10.0% CV criterion)
Linearity	Linear throughout the analytical measuring interval of 0.6-1,500 ng/mL	Linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 0.6-1,500 ng/mL. (Implied to meet the criterion)
Limit of Blank (LoB)
Claimed LoB	0.2 ng/mL	The claimed LoB for Access Ferritin assay is 0.2 ng/mL on Dxl 9000 Access Immunoassay Analyzer. (Implied to meet, as this is the stated claim derived from the study)
Limit of Detection (LoD)
Claimed LoD	0.4 ng/mL	The claimed LoD estimate for the Access Ferritin assay is 0.4 ng/mL on Dxl 9000 Access Immunoassay Analyzer. (Implied to meet, as this is the stated claim derived from the study)
Limit of Quantitation (LoQ)
Maximum claimed LoQ (@ ≤ 20% within-lab CV)	0.6 ng/mL	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. (Implied to meet, as this is the stated claim derived from the study)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size (Method Comparison): 147 samples
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the method comparison samples. It only mentions "patient samples" in the context of the CLSI guidance document referenced (CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples).
Test Set Sample Size (Precision, LoB, LoD, LoQ):
- Precision: 80 replicates for each of the 6 concentration levels (1.2, 13, 147, 289, 560, 1276 ng/mL) are reported in the table. The study design mentions "tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days," which would result in 80 measurements (2 replicates x 2 runs/day x 20 days).
- LoB: 75 replicates of native samples.
- LoD: Five to nine serum samples containing low levels of Ferritin analyte, tested over five days with one run per day and nine replicates per run for each pack lot (resulting in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested).
- LoQ: Eight to twelve serum samples containing low levels of Ferritin analyte, tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument (resulting in a minimum of 40 replicates for each sample on each pack lot).
Provenance for Precision, LoB, LoD, LoQ: Not specified, other than "native samples" or "serum samples."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is an in-vitro diagnostic (IVD) immunoassay for quantitative determination of ferritin levels. Ground truth for such devices is typically established through reference methods or established laboratory gold standards rather than expert consensus on interpretive tasks. The document does not mention any involvement of human experts or radiologists in establishing ground truth for the test set performance evaluation. The "ground truth" here would be the actual ferritin concentration as determined by the predicate device (for method comparison) or highly controlled, characterized samples (for precision, linearity, limits).

4. Adjudication Method for the Test Set

Not applicable. As an IVD immunoassay, the "ground truth" or reference values are determined by laboratory measurements, not by human expert adjudication in the traditional sense (e.g., 2+1 for image interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic imaging or similar interpretive tasks involving multiple human readers. This document describes the performance evaluation of an automated immunoassay system, which does not involve human readers interpreting results in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The entire study describes the standalone performance of the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer. This is an automated system; the performance metrics (method comparison, precision, linearity, limits) are intrinsic to the assay and instrument combination without human intervention in the result generation or interpretation other than standard lab operating procedures.

7. The Type of Ground Truth Used

Method Comparison: The "ground truth" or reference values for the method comparison study were obtained from the predicate device, the Access Ferritin assay run on the Access Immunoassay System (K926221/K052082).
Precision, Linearity, LoB, LoD, LoQ: Ground truth for these studies was established using characterized samples (e.g., samples with known or carefully prepared concentrations, native low-level samples, or blank samples). These are standard practices in IVD analytical performance evaluation.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This is an immunoassay, not a device that uses AI models that require traditional training data. The development of the assay and its associated reagents/software would have involved internal R&D studies, but these are not described as a "training set" in the common AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device with a distinct "training set" as described in AI development. The "ground truth" for developing the assay itself would have involved extensive biochemical and analytical characterization in a laboratory setting.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K234052

Device Name Access Ferritin

Indications for Use (Describe)

Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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

Intended Use

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Comparison of Technological Characteristics to the Predicate (Assay)

SystemAttribute/Characteristic	Predicate Access Ferritinassay (K926221/ K052082)run on the AccessImmunoassay System	Access Ferritin assay run onthe Dxl 9000 AccessImmunoassay AnalyzerInstrument
Intended Use/Indications for Use	The Access Ferritin assay is aparamagnetic particle,chemiluminescentimmunoassay for thequantitative determinationof ferritin levels in humanserum and plasma (heparin)using the AccessImmunoassay Systems.	The Access Ferritin assay is aparamagnetic particle,chemiluminescent immunoassayfor the quantitative determinationof ferritin levels in human serumand plasma (heparin) using theAccess Immunoassay Systems.Ferritin is used as an aid in thediagnosis of iron deficiency oriron 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 calibrationcurve	Same
Sample Type	Serum/Plasma	Same
Stability	28 days after opening	Same
Reagent Packformulation andpackaging	Access Reagent Packformulation and packaging.	Same
Reagent Configurations	One Configuration:100 determinations, 2 packs,50 tests/pack	Two Configurations:1) 100 determinations, 2packs, 50 tests/pack (forpredicate and candidateinstrument)2) 200 determinations, 2packs, 100 tests/pack (forcandidate instrument only)
Measuring Range	0.2-1,500 ng/mLDil-Fer range1,500-15,000 ng/mL	0.6-1,500 ng/mLAutomated dilution: Up toapproximately 75,000 ng/mL(µg/L)
Sample Volume	10 uL	5 uL
Instrument	Access Immunoassay system	Dxl 9000 AccessImmunoassay Analyzer
Substrate	Access Substrate	Lumi-Phos PRO substrate

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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	ConcentrationRange*(ng/mL[ug/L])	Slope	Slope95% Cl	Intercept	Intercept95% 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.

Regulation Number and Section

§ 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).