ACCESS UNCONJUGATED ESTRIOL CALIBRATORS

K012900 · Beckman Coulter, Inc. · JIT · Oct 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012900
• Device Name: ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
• Applicant: Beckman Coulter, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Access Unconjugated Estriol Calibrators set is a device intended for medical purposes for use in the Access Immunoassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum.

Device Story

Access Unconjugated Estriol Calibrators are liquid calibrators used with the Access Immunoassay System. They establish reference points for quantifying estriol levels in human serum samples. Used in clinical laboratory settings by trained personnel. The system uses these calibrators to calibrate the assay, ensuring accurate measurement of patient serum estriol. This aids healthcare providers in clinical decision-making related to estriol monitoring.

Clinical Evidence

Bench testing only. Stability data supports a minimum shelf life of 24 months.

Technological Characteristics

Liquid calibrator set for use with Access Immunoassay System. Class II device (21 CFR 862.1150).

Indications for Use

Indicated for use with the Access Immunoassay System to establish reference points for measuring estriol levels in human serum.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Beckman Coulter Access Unconjugated Estriol Calibrators (K012900)

Submission Summary (Full Text)

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510(k) Summary Prepared 27 August 2001

K012900

### Applicant's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Dr. Chaska, MN 55318

Mara Caler Contact Person: 858 621 4583

Alternate Contact Person: Denise Thompson 952 368 1202

### Device Name

Trade Name - Access® Unconjugated Estriol Calibrators on the Access® Immunoassay Systems Common Name - Unconjugated Estriol Calibrators Classification name - Calibrators (21 CFR 862.1150)

### Predicate Device

Beckman Coulter Access Unconjugated Estriol Calibrators

### Device Description

The Access® Unconjugated Estriol Calibrators are liquid Calibrators to be used with the Access Immunoassay System.

#### Intended Use

The Access Unconjugated Estriol Calibrators set is a device intended for medical purposes for use in the Access Immunoassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum.

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Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye or a wave. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked vertically in a bold, sans-serif font. The overall design is simple and modern, conveying a sense of precision and innovation.

### Comparison to Predicate:

Data is presented to demonstrate substantial equivalence to the predicate.

# Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the Beckman Coulter Access linding of substantial oquivalensitiations already in commercial distribution. Stability Oltraschaltive not . Calibrators support the stability claim of a minimum of 24 months.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them, resembling a bird-like shape.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 6 2001

Ms. Mara Caler Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Re: k012900

Trade/Device Name: Access® Unconjugated Estriol Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: August 27, 2001 Received: August 29, 2001

Dear Ms. Caler:

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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the words "BECKMAN COULTER" on the right. The graphic is a black circle with two white curved lines inside. The text is in a bold, sans-serif font, with "BECKMAN" on top and "COULTER" below.

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510(k) Number (if known): KO12900

Device Name: Access® Unconjugated Estriol Calibrators

### Indications For Use:

The Access Unconjugated Estriol Calibrators set is a device intended for The Access Onconjuguted Estiler Salishmonoassay System, to establish medical purposes to: essare used in the determination of values in the measurement of estriol levels in human serum.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use t (Per 21 CFR 801.109) OR

Over-The Counter Use_

Kesia Alexander for Jean Corpor
(Division Sign-Off)

boratory Devices Vision of Clinical La 140 2400 510(k) Number

(Optional Format 1-2-96)