Predicate Devices

K 992858

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a competitive immunoassay using chemical reactions and chemiluminescence detection, with no mention of AI or ML algorithms for data analysis or interpretation. The performance study is a simple method comparison using linear regression, not indicative of AI/ML model validation.

Therapeutic

No
The device is an in vitro diagnostic device used to measure homocysteine levels to aid in diagnosis and treatment, not to provide therapy.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states, "For in vitro diagnostic use..." and "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."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a competitive immunoassay using reagents and a solid phase, indicating a hardware-based in vitro diagnostic test, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use" and describes the test as being used to measure a substance (total homocysteine) in biological samples (serum or EDTA plasma) to aid in the diagnosis and treatment of patients. This is the core definition of an IVD.
Device Description: The description details a laboratory test that analyzes a sample outside of the body ("in vitro") using chemical and immunological reactions to determine the concentration of a specific analyte (HCY).
Method Comparison: The performance study compares the device to another assay, which is typical for validating an IVD.
Predicate Device: The mention of a predicate device (K992858; IMx Homocysteine) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® 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.

Product codes

75 LPS, LPS, JIS

Device Description

The ADVIA Centaur HCY assay is a competitive immunoassay using direct, The rib vir connecessent 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 four separato reagence, willer in a sample or control to free HCY. A Enzyme provem uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample to S-adenosyinomes Josent (ethe 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 I has . The enemaint of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Method Comparison: 106 samples were assayed on both systems (ADVIA Centaur HCY assay and Abbott IMx Homocysteine assay) and yielded the following linear regression statistics: IMx = 0.98 (ADVIA Centaur) + 0.42 umol/L, R = 0.981

Key Metrics

Not Found

Predicate Device(s)

K 992858

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

DEC 1 82001

K013406

Bayer Diagnostics ADVIA Centaur HCY Assay

Section 2 - Summary of Safety and Effectiveness

1. Submitter Information Kenneth T. Edds, Ph.D. Contact Person: Bayer Diagnostic Corporation Address: 511 Benedict Ave. Tarrytown, N.Y. 10591 Phone: (914) 524 2446 FAX: (914) 524 2500 e-mail: ken.edds.b@bayer.com Date Summary Prepared: 10/10/01 2. Device Information ADVIA Centaur Homocysteine (HCY) Assay Propriety Name: HCY assay Common Name: Classification Name: Urinary Homocysteine Assay Class: II 862.1377 CFR: Product Code: 75 LPS 3. Predicate Device Information IMx Homocysteine Name: 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

The ADVIA Centaur HCY assay is a competitive immunoassay using direct, The rib vir connecessent 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 four separato reagence, willer in a sample or control to free HCY. A Enzyme provem uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample to S-adenosyinomes Josent (ethe 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 I has . The enemaint of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.

1. Statement of Intended Use
  For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® 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.

Summary of Technological Characteristics

The ADVIA Centaur 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 Active
Compound(s) | Abbott Active
Compound(s) |
|--------------------------------------------------------|--------------------------------------|--------------------------------------|
| Chemical reduction of protein bound HCY to
free HCY | Dithiothreitol | Dithiothreitol |
| Enzymatic conversion of HCY to SAH | S-adenosyl
homocysteine hydrolase | S-adenosyl
homocysteine 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 ADVIA Centaur uses chemiluminescence.

7. Method Comparison

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

IMx = 0.98 (ADVIA Centaur) + 0.42 umol/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 eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 82001

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

Re: K013406

Trade/Device Name: Homocysteine Assay for the ADVIA® Centaur™ Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II; Class II Product Code: LPS; JIS Dated: October 12, 2001 Received: October 15, 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 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 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 forth 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 ' 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

K013406 510(k) Number:

Device Name: HCY Assay for the ADVIA® Centaur™

Indications for Use:

For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas C. Ponton, Jr. Jean Cooper
Division Director

(Division Sign-Om
Division of Clinical Laboratory Devices
510(k) Number (K013, 40

Prescription Use (Per 21 CFR 801.109)

Over-The-CounterUse OR

(Optional Format 1-2-96)