The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, 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

The acceptance criteria and device performance information provided in the document focuses on the Access Intrinsic Factor Ab assay's performance on the Dxl 9000 Access Immunoassay Analyzer compared to the Access 2 Immunoassay System (predicate device).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate table, but it provides performance metrics that would serve as the basis for such criteria, particularly for method comparison and imprecision. The comparison is against an existing predicate device, implying that performance should be comparable or non-inferior.

Performance Metric	Acceptance Criteria (Implied/Derived from context)	Reported Device Performance (Access Intrinsic Factor Ab on Dxl 9000)
Method Comparison	Agreement with predicate device (Access 2 Immunoassay System) for Negative, Positive, and Total Agreement. (Specific thresholds are not explicitly stated, but high agreement is expected for substantial equivalence).	Negative Agreement: 100% (39/39)Positive Agreement: 97.5% (78/80)Total Agreement: 96.9% ((39 + 78 + 7) / 128)
Within-Laboratory Imprecision (Total CV)	CV ≤ 10.0%	Sample 1 (Mean 1.0 AU/mL): 4.2%Sample 2 (Mean 1.3 AU/mL): 4.3%Sample 3 (Mean 1.5 AU/mL): 3.9%Sample 4 (Mean 1.6 AU/mL): 4.4%Sample 5 (Mean 3.4 AU/mL): 3.7%Sample 6 (Mean 14 AU/mL): 3.3%(All reported Total CVs are ≤ 10.0%)

2. Sample Size and Data Provenance

Test Set Sample Size:
- Method Comparison: 128 serum samples.
- Imprecision Study: For each of the 6 samples tested, N=80 measurements were performed (implying 80 duplicate measurements over 20 days or similar).
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective analytical validation studies conducted by the manufacturer, Beckman Coulter, Inc.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The studies described are analytical performance validations comparing a new instrument platform to an existing one, and assessing precision. They do not involve human expert interpretation of images or other subjective data for ground truth establishment. The ground truth for the method comparison is the result obtained from the predicate device (Access 2 Immunoassay System), which itself is a quantitative assay.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The studies focus on objective quantitative measurements (concentration levels, agreement with a predicate assay). There is no mention of subjective interpretation requiring adjudication by multiple readers or experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable/provided. The device is an in vitro diagnostic immunoassay, not an imaging AI device that would typically involve human reader evaluation or assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is an immunoassay system, not an AI algorithm. Its performance is inherent to the assay and instrument mechanics. The "standalone" performance is effectively what is reported in the method comparison and imprecision studies.

7. Type of Ground Truth Used

For Method Comparison: The ground truth for evaluating the Access Intrinsic Factor Ab assay on the Dxl 9000 was the results obtained from the predicate device (Access Intrinsic Factor Ab assay on the Access 2 Immunoassay System). This is a comparative analytical performance study.
For Imprecision: The ground truth is the measured concentration of the intrinsic factor antibody within the samples themselves, with variability around that measurement being assessed.

8. Sample Size for the Training Set

This information is not applicable/provided. As an immunoassay, the device does not employ machine learning or AI algorithms that would require a "training set" in the conventional sense. The "training" for such a system would involve optimizing the assay reagents and instrument parameters during development, not a data-driven training set for an algorithm.

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

This information is not applicable/provided for the same reasons as #8.

Summary

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May 3, 2024

Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318

Re: K240800

Trade/Device Name: Access Intrinsic Factor Ab Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: LIG Dated: March 22, 2024 Received: March 25, 2024

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 QS 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 (QS) 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,

Paula V. Caposino -5

Paula Caposino, Ph.D. Deputy Director Division of Chemistry and Toxicology 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) K240800

Device Name Access Intrinsic Factor Ab

Indications for Use (Describe)

It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

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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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 K240800

Date Prepared: Mav 2, 2024

Submitted By:

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Primary Contact:

Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberq@beckman.com

Alternate Contact:

Kuljeet Kaur Senior Manager, Requlatory Affairs Phone: (952) 465-1914 Email: kkaur@beckman.com

Device Name

Common Name: Access Intrinsic Factor Ab Trade Name: Access Intrinsic Factor Ab Classification Name: Radioassay, vitamin b12 Classification Code: LIG Classification Regulation: 862.1810

Predicate Device

Device Name: Access Intrinsic Factor Ab 510(k) Numbers: K033603

Device Description

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Intended Use

The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

Parameter	Access Intrinsic Factor Ab on Access2 Immunoassay System (Predicate)	Access Intrinsic Factor Ab onDxl 9000 Access Immunoassay System
Intended use	The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia	The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
Technology	Two-step immunoenzymatic assay	Same
Format	Chemiluminescent	Same
Calibration	Single level calibrator of liquid synthetic matrix with an intrinsic factor antibody concentration of 1.0 AU/mL	Same
Sample Type	Serum and plasma	Same
ResultsInterpretation	<1.20 AU/mL Negative≥ 1.20 to < 1.53 AU/mL Equivocal≥1.53 AU/mL Positive	Same
Instrument	Access Immunoassay system	Dxl 9000 Access Immunoassay Analyzer
Substrate	Access Substrate	Lumi-Phos Pro Substrate

Comparison of Technological Characteristics to the Predicate

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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 EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline - Second Edition

CLSI EP09c 3d Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition

Summary of Studies

Method Comparison: A comparison of 128 serum samples using the Access Intrinsic Factor Ab assay on the Dxl 9000 Access Immunoassay Analyzer and Access 2 Immunoassay System gave the following statistical data using statistical analysis:

			Access 2
			Negative	Equivocal	Positive
Dxl 9000	Negative		39	1	0
	Equivocal		0	7	2
	Positive		0	1	78
	Total		39	9	80
		NegativeAgreement		39 / 39 =100%
		PositiveAgreement		78 / 80 =97.5%
		TotalAgreement		(39 + 78 +7) / 128 =96.9%

Imprecision: The assay was designed to have within-laboratory imprecision as listed below:

CV ≤10.0%

A study based on CLSI EP05-A3 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 (AU/mL)		Repeatability(Within-run)		Between-run		Between-day		Within-Laboratory(Total)
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Sample 1	80	1.0	0.03	2.7	0.02	1.8	0.03	2.6	0.04	4.2
Sample 2	80	1.3	0.03	2.0	0.02	1.8	0.04	3.3	0.06	4.3
Sample 3	80	1.5	0.04	2.4	0.00	0.0	0.05	3.1	0.06	3.9
Sample 4	80	1.6	0.03	1.7	0.06	3.7	0.02	1.5	0.07	4.4
Sample 5	80	3.4	0.06	1.9	0.08	2.5	0.07	1.9	0.12	3.7

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Concentration (AU/mL)	Repeatability(Within-run)		Between-run		Between-day		Within-Laboratory(Total)
Sample 6	80	14	0.2	1.7	0.2	1.3	0.4	2.6	0.5	3.3

Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are unchanged and transferred from file K033603.

Substantial Equivalence Comparison Conclusion

Beckman Coulter's Access Intrinsic Factor Ab assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Intrinsic Factor Ab assay on the Access 2 Immunoassay System 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

§ 862.1810 Vitamin B

12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.