K Number
K991707
Device Name
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
Manufacturer
Date Cleared
1999-06-01

(13 days)

Product Code
Regulation Number
866.6010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access CEA assay is a paramagnetic particle, chemiluminescent immunossay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay System. CEA measured by the Access Immunoassay System is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
Device Description
The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate, and wash buffer. - . The Access® CEA reagent packs consist of paramagnetic particles coated with monoclonal (mouse) anti-human CEA antibodies in Tris buffered saline, sample diluent, monoclonal anti-human CEA-alkaline phosphatase conjugate in phosphate buffered saline, bovine serum albumin (BSA) and preservatives. - . The Access® CEA calibrators consist of multi-point calibrators for use with the Access CEA assay. The calibrator vials contain zero and approximately 1, 10, 100, 500, and 1000 ng/ml purified CEA, respectively, in a phosphate buffered BSA matrix with preservatives. - . The Access® CEA QC controls consist of approximately 3 ng/ml and 300 ng/ml of human CEA in a phosphate buffered BSA matrix with preservatives. - . The Access® substrate, Lumi-Phos* 530, is a dioxetane-based chemiluminescent substrate. - . The Access® wash buffer consists of Tris buffered saline containing surfactant and preservatives.
More Information

Not Found

No
The description details a standard immunoassay kit and its components, with no mention of AI or ML in the device description, intended use, or performance studies.

No
Explanation: The device is an immunoassay system designed to measure CEA levels as an aid in managing cancer patients, not to directly treat or alleviate a disease.

Yes

The device aids in the management of cancer patients by quantitatively determining Carcinoembryonic Antigen (CEA) levels, which suggests its use in monitoring disease progression or treatment effectiveness.

No

The device description explicitly lists physical reagents, calibrators, controls, substrate, and wash buffer, which are all hardware components. The submission describes an immunoassay system, not a software-only device.

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

Here's why:

  • Intended Use: The intended use explicitly states it's for the "quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum". This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
  • Device Description: The description details reagents, calibrators, and controls used to perform a laboratory test on a biological sample.
  • Nature of the Test: The assay is a "paramagnetic particle, chemiluminescent immunoassay," which is a common type of in vitro diagnostic test.
  • Purpose: The assay is used "as an aid in the management of cancer patients in whom changing CEA concentrations have been observed," indicating a diagnostic or monitoring purpose based on laboratory results.

All these points align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Access CEA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay System. CEA measured by the Access Immunoassay System is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

Product codes

DHX

Device Description

The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate, and wash buffer.
The Access® CEA reagent packs consist of paramagnetic particles coated with monoclonal (mouse) anti-human CEA antibodies in Tris buffered saline, sample diluent, monoclonal anti-human CEA-alkaline phosphatase conjugate in phosphate buffered saline, bovine serum albumin (BSA) and preservatives.
The Access® CEA calibrators consist of multi-point calibrators for use with the Access CEA assay. The calibrator vials contain zero and approximately 1, 10, 100, 500, and 1000 ng/ml purified CEA, respectively, in a phosphate buffered BSA matrix with preservatives.
The Access® CEA QC controls consist of approximately 3 ng/ml and 300 ng/ml of human CEA in a phosphate buffered BSA matrix with preservatives.
The Access® substrate, Lumi-Phos* 530, is a dioxetane-based chemiluminescent substrate.
The Access® wash buffer consists of Tris buffered saline containing surfactant and preservatives.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K981985

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

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Access®CEA Assay

Section 1 D: SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE ACCESS® CEA ASSAY

General Information 1.0

| Device Generic Name: | Carcinoembryonic Antigen (CEA) Immunological
Test System for Management of Cancers |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Access® CEA Reagents for use on the
Access® Immunoassay Analyzer |
| Device Class: | Class II |
| Applicant's Name and Address: | Beckman Coulter, Inc.
Immunodiagnostics Development Center
1000 Lake Hazeltine Drive
Chaska, MN 55318 |
| Date: | May 18, 1999 |

Date:

2.0

Legally Marketed Device

The Modified Access® CEA Immunoassay claims substantial equivalence to the Access® CEA Immunoassay currently in commercial distribution.

FDA 510(k) Number K981985

3.0 Device Description

The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate, and wash buffer.

  • . The Access® CEA reagent packs consist of paramagnetic particles coated with monoclonal (mouse) anti-human CEA antibodies in Tris buffered saline, sample diluent, monoclonal anti-human CEA-alkaline phosphatase conjugate in phosphate buffered saline, bovine serum albumin (BSA) and preservatives.
  • . The Access® CEA calibrators consist of multi-point calibrators for use with the Access CEA assay. The calibrator vials contain zero and approximately 1, 10, 100, 500, and 1000 ng/ml purified CEA, respectively, in a phosphate buffered BSA matrix with preservatives.
  • . The Access® CEA QC controls consist of approximately 3 ng/ml and 300 ng/ml of human CEA in a phosphate buffered BSA matrix with preservatives.
  • . The Access® substrate, Lumi-Phos* 530, is a dioxetane-based chemiluminescent substrate.
  • . The Access® wash buffer consists of Tris buffered saline containing surfactant and preservatives.

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4.0 Principles of the Procedure

The Access® CEA assay is a two-site immunoenzymatic "sandwich" assay using two mouse monoclonal anti-CEA antibodies (MAb) which react with different epitopes of CEA. A sample is added to a reaction vessel, along with the first anti-CEA MAb-alkallne phosphatase conjugate and the second anti-CEA MAb bound to paramagnetic particles. The incubation is followed by a magnetic separation and washing. A chemiluminescent substrate, Lumi-Phos* 530, is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is proportional to the concentration of CEA in the sample. The amount of analyte in the sample is determined by means of a stored, multi-point calibrator curve.

Indications for Use 5.0

The Access CEA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay System. CEA measured by the Access Immunoassay System is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

Description of the Modification to the Legally Marketed Device 6.0

The Access CEA assay has been re-calibrated in order to improve correlation with another commercially available device around the critical decision point of 5.0 ng/ml. There has been no change to the formulation or function of the product. The design change involves a reduction in calibrator mass with no change in labeled calibrator values. Insert changes have been made to reflect results from completed validation studies.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Angela Byland Requlatory Specialist BECKMAN COULTER, INC. 1000 Lake Hazeltine Drive Chaska, MN 55318

Re: K991707 Trade Name: Access® CEA Reagents for use on the Access® Immunoassay Analyzer Regulatory Class: II Product Code: DHX May 18, 1999 Dated: May 19, 1999 Received:

Dear Ms. Byland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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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Beckman Coulter, Inc.

Special 510(k): Device Modification Confidential

Section 1 C:

INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number: K984885 K991707

Dovice Name: Access® CEA Reagents for use on the Access® Immunoassay Analyzer

Indications for Use:

The Access CEA assay is a paramagnetic particle, chemiluminescent immunossay for the The Access CEA assay is a paramagnetic particle (CEA) levels in human setem, using the super les and quantitative determination of Cardidentifyone Antigen Cerca in Naman Sales (1 and 18 and Access Immunoassay System. CEA measured by the Acouse Minores of Submitten observed.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Peter E. Mahar

(Divisior: S. Divisidi 510(x) Number

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-The Counter Use_

(Optional Format 1-2-96)

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