ACCESS TOTAL BHCG

K023480 · Beckman Coulter, Inc. · JHI · Dec 20, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023480
• Device Name: ACCESS TOTAL BHCG
• Applicant: Beckman Coulter, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Access® Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total ßhCG levels in human serum and plasma using the Access Immunoassay Systems.

Device Story

Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay; used on Access Immunoassay Systems. Input: human serum or plasma samples. Principle: quantitative measurement of total βhCG levels. Output: quantitative concentration values. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in determining pregnancy status. Benefit: provides early detection of pregnancy.

Clinical Evidence

Bench testing only. Method correlation study conducted comparing paired plasma and serum samples to validate the addition of plasma as an acceptable sample type. Results demonstrated good correlation between the two sample matrices.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components include reagent pack, calibrators, substrate, and wash buffer. Designed for use on Access Immunoassay Systems. No specific materials or software algorithm class details provided.

Indications for Use

Indicated for in vitro quantitative determination of total βhCG in human serum and plasma for patients where early detection of pregnancy status is desired.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• Access Total BhCG assay (K980173)

Submission Summary (Full Text)

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# 510(k) Summary

[As required by 21 CFR 807.92]

# 510(k) Number QQA3480

Date Prepared: 10/16/2002

| Submitter | Contact Person |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Beckman Coulter, Inc - Diagnostics<br>Division<br>1000 Lake Hazeltine Drive<br>Chaska, MN 55318 | Denise Thompson<br>Regulatory Affairs Specialist<br>Phone: [phone]; Fax: [phone] |

#### General Information

| Trade Name | Access® Total βhCG |
|---------------------|---------------------------------------------------------------------|
| Common Name | Human chorionic gonadotropin |
| Classification Name | Human chorionic gonadotropin (HCG) test system (21 CFR<br>862.1155) |

#### Device Description

The Access Total BhCG assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffer.

#### Intended Use

The Access® Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total ßhCG levels in human serum and plasma using the Access Immunoassay Systems.

#### Substantial Equivalence Comparison

The Access Total ßhCG assay is substantially equivalent to the previously cleared Access Total BhCG assay (K980173). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays include the same components. The only difference between the two assays is that the sample type has been expanded to include human plasma samples.

#### Supporting Data

To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access Total βhCG assay. Study results demonstrate good correlation between the plasma and serum samples.

#### Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Access Total BhCG assay.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Denise Thompson Regulatory Affairs Specialist . Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re:

k023480 -Trade/Device Name: Access® Total BhCG on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI; JIT Dated: October 16, 2002 Received: October 17, 2002

Dear Ms. Thompson:

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 (21 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] 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 Statement

Page 1 of 1

510(k) Number: K023480

Device Name: Access® Total βhCG on the Access® Immunoassay Systems

#### Indications:

The Access Total βhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total βhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

prescription use

Alan Cooper

of Clinical Laborate