The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.

Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency.

Device Description

The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrator S0 and the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, UniCel Dxl™ 800, and UniCel DxC 600i) comprise the Access Immunoassay Systems for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells.

AI/ML Overview

The provided text describes a 510(k) summary for the "Access Folate on the Access Immunoassay Systems" device. However, it does not include a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes for test sets, expert information, or multi-reader studies.

The document states that the modification to the device (a change in buffers and re-establishment of the reference interval) "does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device." This implies that the device is considered substantially equivalent to its predicate device, and thus, its performance is assumed to meet the same standards as the predicate.

Given the information, I can only extract the intended use and technological characteristics for comparison, but not performance data from a specific study with acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria or quantitative performance data from a study demonstrating specific metrics like sensitivity, specificity, or accuracy. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.

The "Acceptance Criteria" here are implicitly centered around demonstrating that the modified device's characteristics are "Same" or do not significantly alter the established performance of the predicate device.

Attribute	Acceptance Criteria (Implicit)	Reported Device Performance (Modified Device)
Intended Use	Should remain the same as the predicate device.	Same
Methodology	Should remain the same as the predicate device.	Same
Product Type	Should remain the same as the predicate device.	Same
Sample Type	Should remain the same as the predicate device.	Same
Assay Components	Should remain the same as the predicate device (apart from the specified buffer change which is deemed not to affect safety/efficacy).	Same
Solid Phase	Should remain the same as the predicate device.	Same
Conjugate	Should remain the same as the predicate device.	Same
Calibrators	Should remain the same as the predicate device regarding composition and levels.	Same
Reportable Range	Should remain the same as the predicate device.	Serum folate: 0.5 – 20 ng/mL
Sample Size	Should remain the same as the predicate device.	55 μl
Impact of	The modification (change in buffers for pH adjustment and re-establishment of reference interval) should not affect the intended use, indications, fundamental scientific technology, safety, or efficacy of the device.	"Does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device."

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

The document does not specify a sample size for a test set as part of a performance study. It mentions the re-establishment of the "reference interval to reflect the prevalence of folic acid fortification of foods," which would imply a study was done for this purpose, but no details on sample size, data provenance (country of origin, retrospective/prospective), or methodology are provided.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

This is an immunoassay device, not an AI-assisted diagnostic imaging or interpretation system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This is an immunoassay device, which measures folic acid levels quantitatively. Its performance is inherent to the assay itself, not an algorithm in the typical sense of AI or image analysis. The "standalone" performance would be the assay's precision, accuracy, linearity, etc., none of which are detailed here as acceptance criteria in the context of this 510(k) summary. The document states the modification "does not affect the safety and efficacy of the device," implying prior standalone performance was established for the predicate.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For an immunoassay, "ground truth" typically refers to:

Reference Standards: For accuracy/calibration.
Clinical Samples with Confirmed Folate Status: For establishing reference intervals or clinical correlation.
Spiked Samples: For analytical recovery.

The document mentions "re-establishment of the reference interval," which would rely on clinical samples from a population to define normal/expected folate levels. However, specific details about confirmed folate status or how this "ground truth" was established are not provided.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. For an immunoassay, method validation studies would involve various samples for calibration, linearity, precision, and accuracy, but these are not referred to as "training sets."

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

As no training set (in the AI/ML sense) is mentioned, this information is not applicable. For typical immunoassay validation, ground truth for analytical performance (e.g., accuracy) is established using reference materials or split samples tested by a highly accurate reference method. For clinical performance, it's typically established using carefully characterized patient samples. Specific details are not provided in this summary.

Summary

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APR 2 1 2006

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.

The assigned 510(k) number is: K060774

Submitter's Name and Address

Beckman Coulter. Inc. 1000 Lake Hazeltine Drive Chaska. MN 55318 Telephone: (952) 368-7869 Fax: (952) 368-7610 Contact: Carolyn Anderson

Date Prepared: March 20, 2006

Device Names

Folate on the Access® Immunoassay Systems Proprietary Name:

Common Name: Folate test system
Classification Name: Folic Acid test system

Predicate Device

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

510(k) Numbers: K932887, K943149, K955434

Device Description

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Intended Use

Attribute	Access Folate Assay	Access Folate Assay (modified)
Intended Use	Quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is and indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency.	Same
Methodology	Chemiluminescent immunoassay (two step competitive binding receptor assay)	Same
Product type	Reagent	Same
Sample type	Human serum, plasma (heparin) or red blood cells	Same
Assay components	Reagent pack, calibrators, lysing agent, Folate Calibrator S0	Same
Solid Phase	Goat anti-mouse capture antibody coupled to paramagnetic particles	Same
Conjugate	Folic acid-alkaline phosphatase conjugate	Same
Calibrators	Folate (pteroylglutamic acid) in buffered matrix at levels of 0 and approximately 1.0, 2.5, 5.0, 10.0, and 20.0 ng/mL (2.3, 5.7, 11.3, 22.7, and 45.3 nmol/L)	Same
Reportable Range	Serum folate: 0.5 – 20 ng/mL	Serum folate: 0.5 – 20 ng/mL
Sample Size	55 μL	55 μl

Comparison of Technological Characteristics

Summary of Technological Characteristics

The device modification consists of a change in buffers for pH adjustment and the reestablishment of the reference interval to reflect the prevalence of folic acid fortification of foods. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device.

Conclusion

The modified Access Folate on the Access Immunoassay Systems is substantially equivalent to the Access Folate assay for the quantitative determination folic acid levels in human serum, plasma (heparin) and red blood cells.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carolyn Anderson Schior Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

APR 2 1 2006

Re: K060774

Trade/Device Name: Access Folate on the Access® Immunoassay Systems Regulation Number: 21 CFR& 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: March 20, 2006 Received: March 22, 2006

Dear Ms. Anderson:

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 (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. 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Gutt

Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Access Folate on the Access® Immunoassay Systems

Indications For Use:

Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.

Prescription Use

AND/OR

alary

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Hemen

Page 1 of 1

Regulation Number and Section

§ 862.1295 Folic acid test system.

(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.