ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE

K992859 · Radiometer America, Inc. · CHL · Jan 10, 2000 · Clinical Chemistry

Device Facts

• Record ID: K992859
• Device Name: ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
• Applicant: Radiometer America, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jan 10, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.

Device Story

The ABL700 with AutoCheck Module is an automated blood gas and electrolyte analyzer. It incorporates an AutoCheck module, which features an ampoule carrousel holding 20 quality control (QC) fluid ampoules and a barcode reader. The device automatically performs QC analysis by reading ampoule barcodes, breaking the ampoule caps, and introducing fluid into the analyzer inlet. The system alerts the user when QC is due and performs the analysis upon acceptance. It is intended for clinical use to provide diagnostic measurements of blood parameters. The device benefits patients by ensuring analyzer accuracy through automated, scheduled quality control, reducing manual intervention and potential errors in the testing process.

Clinical Evidence

No clinical data provided; device relies on bench testing and comparison of technological characteristics to the predicate ABL700 series.

Technological Characteristics

The device is a blood gas/electrolyte/metabolite analyzer with an integrated automated QC module. It utilizes an ampoule carrousel and barcode reader for automated QC fluid handling. Software controls the automated sampling and measurement process. The system is designed for clinical laboratory use.

Indications for Use

Indicated for use on human arterial, venous, and capillary whole blood to measure pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca2+, Cl-), metabolites (Glucose, Lactate), and co-oximetry parameters.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• RADIOMETER ABL700 Series (K980130)
• RADIOMETER Qualicheck 5+ (K980135)
• AVL9181 Electrolyte Analyzer (K972673)

Submission Summary (Full Text)

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## RADIOMETER AMERICA INC.

MEDICAL DIVISION

810 SHARON DRIVE, WESTLAKE, OHIO 44145
810 SHARON DRIVE, 800-736-0600, 440-871-8900

## JAN 1 0 2000

| SUBJECT: | 510(K) SUMMARY NUMBER: K992859 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FROM: | Vince Sigmund<br>Manager of Customer Relations & Technical Support<br>Radiometer America Inc.<br>810 Sharon Drive<br>Westlake, Ohio 44145<br>[phone], Ext. 209 or 1-800-736-0600<br>Fax [phone]      871- 2510 |
| DATE: | November 22, 1999 |
| PRODUCT: | Trade Name: ABL700 with AutoCheck Module<br>Common Name: pH/Blood Gas/Co-oximetry/Electrolyte/Metabolyte<br>Analyzer<br>Classification Name: Blood Gas and Blood pH Test System |
| PREDICATE DEVICE: | RADIOMETER ABL700 Series (K980130, RADIOMETER Qualicheck 5+<br>(K980135) and AVL9181 Electrolyte Analyzer (K972673). |
| PRODUCT DESCRIPTION: | The ABL700 Series Analyzer with the AutoCheck module is an ABL700<br>Analyzer with the added capability of performing automated analysis of<br>quality control fluids. The AutoCheck module is designed to work with a<br>quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is<br>an ampouled four level quality control fluid system. The composition of the<br>various levels of Quality control fluids in AutoCheck 5+ correspond to the<br>composition of the corresponding levels of Qualicheck 5+ system (K980135).<br><br>The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules<br>designed to break the top of an ampoule when it is to be used. Furthermore,<br>each ampoule has a bar code containing information on the specific level and<br>lot of the quality control fluid.<br><br>Installing an AutoCheck module into an existing ABL700 Series Analyzer<br>includes physically installing the module and loading upgraded software<br>which controls the function of the AutoCheck module. The AutoCheck<br>module comprises an ampoule carrousel carrying 20 ampoules of quality<br>control fluid and further comprises a bar code reader for reading the bar<br>code located on each ampoule. When installed into the ABL700 Series<br>Analyzer, the AutoCheck module automatically performs the quality control<br>of the analyzer. Thus, when a quality control is due, the analyzer warns the<br>user and if the user accepts, the quality control is performed. The software<br>selects the appropriate ampoule, the AutoCheck module opens the ampoule<br>by pressing the cap through the top of the ampoule, the quality control fluid<br>is automatically introduced into the analyzer inlet and the measurements are<br>performed. The upgraded software controls all steps. If required, a manual<br>quality control may be performed as well. |

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# RADIOMETER AMERICA INC.

| MEDICAL DIVISION | 810 SHARON DRIVE, WESTLAKE, OHIO 44145<br>800-736-0600, 440-871-8900<br>FAX [phone] |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The automatic inlet of sample loaded into a carrousel is a principle, which<br>is well known from various types of analyzers. Thus, it is well known in<br>coagulation and/or urine analyzers that the samples to be measured are<br>loaded with a sample carrousel. Also, the AVL9181 Electrolyte Analyzer<br>(K972673) for measuring electrolytes in i. a. whole blood, serum, or plasma<br>comprises a built-in autosampler. For further details of performing the<br>automatic quality control in the ABL700 Series Analyzer with the<br>AutoCheck module I refer to the enclosed sections of the Operator's<br>Manual. |
| INTENDED USE: | The ABL700 Series Analyzer with the AutoCheck module is a stand-alone<br>blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-,<br>Glucose, Lactate, and Co-oximetry parameters on human arterial/venous<br>and capillary whole blood. The AutoCheck Module is an added<br>functionality to perform automated analysis of quality control fluids. |
| TECHNOLOGICAL<br>CHARACTERISTICS<br>VERSUS PREDICATE<br>DEVICE: | Similar to the ABL700 Series |
| SUBSTANTIAL<br>EQUIVALENCE: | The ABL700 Series Analyzer with the AutoCheck module is substantially<br>equivalent in features and characteristics to the current ABL700 Series<br>(K980130) marketed by Radiometer America Inc. |

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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 depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### JAN 1 0 2000

Mr. Vincent M. Sigmund Product Manager, Quality Services Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145

K992859 Re:

> Trade Name: ABL700 with AutoCheck Module Regulatory Class: II Product Code: CHL, JFP, CGZ, CGA, KHP, CEM, JGS, GKF Regulatory Class: I Product Code: JJS, KHP Dated: December 22, 1999 Received: December 23, 1999

Dear Mr. Sigmund:

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 (OS) 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 [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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### EXHIBIT III

#### 510(k) NUMBER (IF KNOWN): K992859

DEVICE NAME: ABL700 with AutoCheck Module

#### INDICATIONS FOR USE:

The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa*, cK+, cCa2+, cCL; Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.

Dan Cooper

510(k) Number

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

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

OR

Prescription Use Use (Per 21 CFR 801-109) Over-The-Counter-

(Optional Format 1-2-96)