Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180 System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocystinuria or hyperhomocysteinemia.

Device Description

The ACS:180 HCY assay is a competitive immunoassay using direct, chemiluminescent technology. It is intended to measure the amino acid Homocysteine (HCY) in serum or EDTA plasma. The homocysteine assay requires four separate reagents, which are added sequentially. A Reducing Reagent releases protein bound and dimerized HCY in a sample or control to free HCY. A Enzyme Reagent uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample competes with SAH bound to the Solid Phase for binding to a monoclonal anti SAH antibody-acridinium ester conjugate in the Lite Reagent. Following incubation. unbound SAH and anti SAH-acridinium ester conjugate are washed from the Solid Phase. The chemiluminescence of the acridinium ester bound to the Solid Phase is measured. The amount of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.

AI/ML Overview

This document describes the Bayer Diagnostics ACS:180 HCY Assay, a device for measuring Homocysteine (HCY) levels.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly state numerical "acceptance criteria" for the ACS:180 HCY assay in the traditional sense (e.g., a minimum sensitivity or specificity). Instead, the performance is demonstrated by comparing it to a legally marketed predicate device. The primary performance metric presented is the correlation with the predicate device.

Acceptance Criterion	Reported Device Performance (ACS:180 HCY Assay)
Equivalence to Predicate Device (Abbott IMx Homocysteine assay)	Linear regression: IMx = 0.98 (ACS:180) + 0.43 µmol/L
Correlation with Predicate Device	R = 0.981

2. Sample sized used for the test set and the data provenance

Sample Size: 106 samples
Data Provenance: The document does not specify the country of origin of the data or whether the samples were collected retrospectively or prospectively.

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. For an immunoassay device like this, the "ground truth" is typically established by the results from a reference method or a predicate device. Expert adjudication is not usually applied to the readings of quantitative assays in the same way it would be for image-based diagnostic AI.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in scenarios where human interpretation of complex data (e.g., medical images) is involved to establish a ground truth or resolve discrepancies. For a quantitative immunoassay, the values produced by the reference method (in this case, the predicate device) are taken as the comparative standard.

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 information is not provided and is not applicable to this type of device. The ACS:180 HCY Assay is an automated in vitro diagnostic test, not an AI-assisted diagnostic tool that requires human interpretation in the loop. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

Yes, the study presented demonstrates the standalone performance of the ACS:180 HCY assay. The device directly measures HCY levels in serum or EDTA plasma without human interpretation influencing the measurement outcome. Its performance is compared directly against the predicate device's measurements.

7. The type of ground truth used

The "ground truth" for evaluating the performance of the ACS:180 HCY Assay was established by comparison to the Abbott IMx Homocysteine assay, which is a legally marketed predicate device. While not "pathology" or "outcomes data" in the strictest sense, the predicate device serves as the accepted standard for measuring HCY levels against which the new device's accuracy and correlation are assessed.

8. The sample size for the training set

This information is not provided. For a traditional immunoassay, there isn't a "training set" in the machine learning sense. Assay development involves optimizing reagents, protocols, and calibration curves, but it's not typically described as a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons mentioned in point 8.

Summary

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DEC 21 2001

Bayer Diagnostics ACS:180 HCY Assay

K013606

Section 2 - Summary of Safety and Effectiveness

1. Submitter Information

	Contact Person:	Kenneth T. Edds, Ph.D.
	Address:	Bayer Diagnostic Corporation511 Benedict Ave.Tarrytown, N.Y. 10591
		Phone: (914) 524 2446FAX: (914) 524 2500e-mail: ken.edds.b@bayer.com
	Date Summary Prepared:	10/24/01
2.	Device Information
	Propriety Name:	ACS:180 HCY Assay
	Common Name:	HCY assay
	Classification Name:Class:CFR:Product Code:	Homocysteine AssayII862.137775 LPS

1. Predicate Device Information

Name:	IMx Homocysteine
Manufacturer:
Manufactured by:	Axis-Shield ASA
	Ulvenveien 87
	N-0581 Oslo, Norway
Manufactured for:	Abbott Laboratories
	Abbott Park Road
	Abbott Park, Il. 60064
510(k) Number:	K 992858

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4. Device Description

1. Statement of Intended Use
  Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180 System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

6. Summary of Technological Characteristics

The ACS:180 HCY assay is similar to the Abbott IMx Homocysteine assay in several ways. Both require a chemical and enzymatic step to occur before the actual immunoassay starts. The similarities between the Bayer and Abbott reagents are summarized below:

Step	Bayer ActiveCompound(s)	Abbott ActiveCompound(s)

Chemical reduction of protein bound HCY tofree HCY	Dithiothreitol	Dithiothreitol
Enzymatic conversion of HCY to SAH	S-adenosylhomocysteine hydrolase	S-adenosylhomocysteine hydrolase
Analyte in Calibrator	SAH	SAH
Antibody	Mouse monoclonal anti-SAH	Mouse monoclonal anti-SAH

The systems differ in their detection systems, Abbott assay uses fluorescence polarization while the ACS:180 uses chemiluminescence.

7. Method Comparison

We have compared the ACS:180 HCY assay to the Abbott IMx Homocysteine assay in performance. 106 samples were assayed on both systems and vielded the following linear regression statistics:

IMx = 0.98 (ACS:180) + 0.43 µmol/L, R = 0.981

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

K013606 Re:

Trade/Device Name: Homocysteine Assay for the ACS:180 Regulation Number: 21 CFR 862.1377; 21 CFR 862.1150 Regulation Name: Urinary homocystine (non-quantitative) test system; Calibrator Regulatory Class: Class II; Class II Product Code: LPS; JIS Dated: October 29, 2001 Received: October 31, 2001

Dear Dr. Edds:

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 for are and in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer to Prize to 112) 2011 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 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.

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); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

大013606 510(k) Number:

Device Name: HCY Assay for the ACS:180

Indications for Use:

Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180® System. This nomocyooms (1101) igned to quantitatively measure HCY in serum or EDTA diagnosis tool is acception of can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

Thomas C. Mort for Ann Cooper
(Division Sign-Off)

Division of Clinical Laboratory 510(k) Number

(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)

Over-The-CounterUse

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1377 Urinary homocystine (nonquantitative) test system.

(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.