ACCESS OSTASE QC

K994277 · Beckman Coulter, Inc. · JJX · Jan 14, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994277
• Device Name: ACCESS OSTASE QC
• Applicant: Beckman Coulter, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

Device Story

Access Ostase QC is a bi-level, ready-to-use, protein-based liquid control material. It is used in clinical laboratories by laboratory personnel to monitor the performance of the Access Ostase Immunoassay system. The device serves as a reference to assess analytical error, imprecision, and linearity of the immunoassay system. By running these controls, the laboratorian can verify that the immunoassay system is functioning within expected parameters, thereby ensuring the reliability of patient test results generated by the system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bi-level, ready-to-use, protein-based liquid control material. Packaged in 4 mL bottles. Designed for use with the Access Ostase Immunoassay system. No specific materials of construction or software algorithms are described.

Indications for Use

Indicated for use in clinical laboratories to monitor the reliability, performance, linearity, analytical error, and imprecision of the Access Ostase Immunoassay system. No specific patient population is targeted as this is an in vitro diagnostic quality control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Access AFP QC (K981864)

Submission Summary (Full Text)

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## JAN 1 4 2000

K994277

### Summary of Safety & Effectiveness Access Ostase QC

#### 1.0 Submitted By:

Mara Caler Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 7330 Carroll Road P.O. Box 269006 San Diego, CA 92196-9006 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

December 15, 1999

### 3.0 Device Name(s):

### 3.1 Proprietary Names

Access Ostase QC

#### 3.2 Classification Name

Quality Control Material (assayed and unassayed) (21 CFR § 862.1660)

### 3.3 Device Classification

Class I (low risk)

#### 4.0 Predicate Device(s):

| BECKMAN<br>COULTER Reagent | Predicate | Predicate Company | Docket<br>Number |
|----------------------------|------------------|----------------------|------------------|
| Access Ostase QC | Access<br>AFP QC | Beckman Coulter Inc. | K 981864 |

{1}------------------------------------------------

### 5.0 Description:

The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.

### 6.0 Intended Use:

Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

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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 stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

# JAN 1 4 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mara Caler Regulatory Specialist Beckman Coulter, Inc. P.O. Box 269006 7330 Carroll Road San Diego, California 92196-9006

Re: K994277 Trade Name: Access® Ostase® OC Regulatory Class: I reserved Product Code: JJX Dated: December 15, 1999 Received: December 20, 1999

Dear Ms. Caler:

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 OS 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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### Page 2

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 [phone].

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 [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"(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 [phone] or [phone], 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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K994277 510(k) Number (if known): Not yet assigned

Device Name: Access® Ostase® QC

Indications for Use:

Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

21 CFR 862.1660 Quality Control Material (assayed and unassayed)

(a) Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency studies in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes. enzymes, multianalytes (all kinds), single (specified) analytes, or urinalvsis controls.

(b) Classification. Class I.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory

510(k) Number K994277

| Prescription Use<br>(per 21 CFR 801.109) | <img alt="check" src="check.jpg"/> | OR | Over-the-Counter Use<br>Optional Format 1-2-96 |
|------------------------------------------|------------------------------------|----|------------------------------------------------|
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Beckman Coulter Inc., Section 510(k) Notification Access® Ostase® QC AccessOstaseQC/Ostase510(k)sec1.doc

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