Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The binding assay is intended for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.

Device Description

The Elecsys® Folate II Assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate labeled with biotin for the binding sites on the ruthenium labeled FBP-complex.

AI/ML Overview

Here's an analysis of the provided text regarding the Elecsys® Folate II Assay, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) Summary for a laboratory assay (in vitro diagnostic device). This type of device does not typically involve the same type of "acceptance criteria" and "studies" as an AI-powered diagnostic device, especially regarding aspects like "sample size used for the test set," "number of experts," "adjudication method," "MRMC studies," or "standalone performance" in the context of image analysis or algorithm-based diagnostics.

For a laboratory assay, "acceptance criteria" generally refer to performance characteristics like precision, accuracy, linearity, measuring range, interference, and agreement with a predicate device. The "studies" are typically analytical and clinical validation studies demonstrating these characteristics.

Given this context, I will address your questions from the perspective of an in vitro diagnostic device.

Description of Acceptance Criteria and Supporting Study for Elecsys® Folate II Assay

The Elecsys® Folate II Assay is a binding assay for the in vitro quantitative determination of folate in human serum, intended for use on Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers. It is used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The device claims substantial equivalence to the previously marketed Elecsys® Folate Assay (K973674).

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like this, "acceptance criteria" and "reported device performance" are often demonstrated through comparison with a predicate device and validation of key analytical specifications. The summary explicitly states a comparison to a predicate device and highlights areas of similarity and difference.

Performance Characteristic	Acceptance Criteria (Implied by Predicate & Assay Type)	Elecsys® Folate II Reported Performance (where available)
Intended Use	Same as predicate Elecsys® Folate (K973674)	Same
Method	Competitive chemiluminescent immunoassay	Same
Sample Type	Human Serum	Same
Measuring Range	0.600 - 20.00 ng/ml (or 1.36 - 45.4 nmol/L)	Same
Expected Values	Similar to predicate, but with potentially refined range	3.1 - 17.5 ng/ml (Predicate: 4.2 - 19.9 ng/ml)
(Implied) Precision	Meet established internal and regulatory standards for IVD assays	Not explicitly detailed in this summary
(Implied) Accuracy	Demonstrate agreement with predicate and/or reference methods	Not explicitly detailed in this summary
(Implied) Linearity	Demonstrate linear response across measuring range	Not explicitly detailed in this summary
(Implied) Interference	Demonstrate lack of significant interference from common substances	Not explicitly detailed in this summary

Note: The provided 510(k) summary is highly abbreviated. Detailed acceptance criteria for precision, accuracy, linearity, etc., would typically be found in the full 510(k) submission, not necessarily in the public summary. The change in "Expected Values" is a notable difference that would have required specific clinical validation.

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

The provided 510(k) summary does not specify sample sizes used for performance testing (e.g., precision, accuracy, comparison studies). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

For an In Vitro Diagnostic (IVD) device, studies typically involve:

Analytical Studies: Using controlled panels, spiked samples, and patient samples to assess precision, accuracy, linearity, limits of detection/quantitation, interference, etc. The "test set" here would refer to the number of samples and replicates used in these analytical studies.
Clinical Studies (if applicable): Patient samples analyzed and compared to a reference method or clinical outcome, often guided by the change in expected values.

Without the full submission, these details are not available from the given text.

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

This concept is not applicable to an in vitro diagnostic assay like the Elecsys® Folate II. Ground truth for an assay is established by:

Reference Methods: Highly accurate and precise methods (e.g., LC-MS/MS for folate)
Expert Diagnosis/Clinical Outcome: For clinical utility, the assay's results would be correlated with the clinical diagnosis of anemia, but "experts to establish ground truth for the test set" (as in image interpretation) doesn't fit here.
Predicate Device Results: For substantial equivalence, results are often compared to the legally marketed predicate device.

4. Adjudication Method for the Test Set

This concept is not applicable to an in vitro diagnostic assay. Adjudication, like 2+1 or 3+1, is typically used for subjective assessments (e.g., radiology image interpretation) where human readers disagree. For an assay, results are quantitative or qualitative measurements, and disagreement implies a technical issue with the assay or instrumentation, not an interpretation difference requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This concept is not applicable to an in vitro diagnostic assay. MRMC studies are designed to compare the performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. An IVD assay is a standalone measurement device; there are no "human readers" interpreting its output in a comparative effectiveness study in this manner.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Elecsys® Folate II Assay is a standalone device. It is an immunoassay system where the instrument (Elecsys 2010 or Modular Analytics E170) performs the measurement and provides a quantitative result. The human "in the loop" aspects are sample preparation, loading, and interpretation of the numerical result; the assay itself does not involve an "algorithm" in the sense of AI image analysis. Its performance is always its "standalone" performance.

7. The Type of Ground Truth Used

For an in vitro diagnostic assay, the ground truth is typically established through:

Reference Measurement Procedures: Highly accurate and precise methods for measuring folate, often involving mass spectrometry or validated chromatographic techniques.
Comparison to Predicate Device: Demonstration of agreement (correlation, bias) with the legally marketed predicate device.
Clinical Diagnosis/Outcomes Data: For understanding diagnostic utility, folate levels would be correlated with the clinical diagnosis of folate deficiency anemia and associated clinical outcomes.

The provided summary does not explicitly state which "ground truth" method was predominantly used for the performance studies, but given its role as an IVD, comparison to a reference method and/or the predicate device would be standard.

8. The Sample Size for the Training Set

This concept is not applicable to the Elecsys® Folate II Assay. This device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set." Its calibration and validation methods are based on analytical chemistry principles and statistical methods, not machine learning training.

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

This question is not applicable as there is no "training set" for this type of device (see point 8).

Summary

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JUN 2 5 2003

510(k) Summary - Elecsys® Folate II Assay

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence
Submittername, address,contact	Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831
	Contact person: Sherri L. Coenen
	Date prepared: June 6, 2003
Device Name	Proprietary name: Elecsys® Folate II Assay
	Common name: Elecsys® Folate II Assay
	Classification name: Vitamin B12 Test System
Devicedescription	The Elecsys® Folate II Assay employs a competitive test principle usingnatural folate binding protein (FBP) specific for folate. Folate in the samplecompetes with the added folate labeled with biotin for the binding sites on theruthenium labeled FBP-complex.
Intended use	Binding assay for the in vitro quantitative determination of folate in humanserum. The binding assay is intended for use on the Roche Elecsys 2010 andModular Analytics E170 immunoassay analyzers.
PredicateDevice	We claim substantial equivalence to the currently marketed Elecsys® FolateAssay. (K973674).

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510(k) Summary - COBAS Integra Creatinine plus ver.2,

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Reagent Summary

The following table describes the similarities and differences between the Elecsys® Folate II Assay and the predicate device.

Topic	Elecsys® Folate(K973674)	Elecsys® Folate II(Modified Device)
Intended Use	Binding assay for the in vitroquantitative determination of folate inhuman serum. The binding assay isintended for use on the RocheElecsys 2010 and Modular AnalyticsE170 (Elecsys Module) immunoassayanalyzers.	Same
Method	competitive chemiluminescentimmunoassay	Same
Sample type	Human Serum	Same
Measuringrange	0.600 - 20.00 ng/ml or1.36 - 45.4 nmol/L	Same
Expectedvalues	4.2 - 19.9 ng/ml	3.1 - 17.5 ng/ml

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

JUN 2 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

K031756 Re:

Trade/Device Name: Elecsys® Folate II Assay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: June 3, 2003 Received: June 6, 2003

Dear Ms. Coenen:

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. Ilsting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If vour 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 (21 CFR Part 820).

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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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): N/A

Device Name: Elecsys® Folate II Assay

Indications For Use:

gastomicsema intracted for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)

Alberto Suts

Division Sign-Off	for Jean Cooper
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Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)	K031756
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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.