ABL 735 ANALYZER

K991417 · Radiometer America, Inc. · CHL · Nov 24, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991417
• Device Name: ABL 735 ANALYZER
• Applicant: Radiometer America, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb, and FHHbF).

Device Story

ABL735 is an automated benchtop analyzer (44cm x 70cm x 50cm; 30kg) for whole blood analysis. Device processes whole blood samples to provide quantitative measurements of pH, blood gases, electrolytes, metabolites, bilirubin, and co-oximetry parameters in approximately 60 seconds. Operated by clinical laboratory personnel in professional healthcare settings. Output is displayed for healthcare providers to assist in clinical decision-making regarding patient metabolic and respiratory status. Benefits include rapid diagnostic turnaround for critical care parameters.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparison to predicate devices.

Technological Characteristics

Automated benchtop analyzer for whole blood. Measures pH, blood gases, electrolytes, metabolites, and co-oximetry via electrochemical and spectrophotometric sensing. Dimensions: 44cm x 70cm x 50cm; Weight: 30kg. Analysis time: ~60 seconds.

Indications for Use

Indicated for in vitro diagnostic testing of whole blood samples to measure pH, blood gases (pO2, pCO2), electrolytes (potassium, sodium, calcium, chloride), metabolites (glucose, lactate), total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and hemoglobin fractions) in clinical settings.

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 (K980130)
• Unistat (Leica Inc., K922770)
• Advanced Bilirubin Stat Analyzer Model BR2 (Advanced Instruments Inc., K790608)
• Vitros (Johnson and Johnson Clinical Diagnostics, K840606; K840880)

Submission Summary (Full Text)

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## RADIOMETER AMERICA INC.

MEDICAL DIVISION

810 SHARON DRIVE, WESTLAKE, OHIO 44145
800-736-0600, 440-871-800-736-0600, 440-871-8800
FAX

NOV 2 4 1999

| SUBJECT: | 510(K) SUMMARY NUMBER: K991417 |
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| 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] |
| DATE: | May 11, 1999 |
| PRODUCT: | Trade Name: ABL735<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 (K980130), for neonate bilirubin testing the Unistat<br>(Leica Inc., K922770) and the Advanced Bilirubin Stat Analyzer Model<br>BR2 (Advanced Instruments Inc., K790608) and for adult bilirubin testing<br>the Vitros (Johnson and Johnson Clinical Diagnostics, formerly Kodak<br>Clinical Diagnostics, K840606; K840880). |
| PRODUCT<br>DESCRIPTION: | ABL735 is an automated pH/Blood Gas/Co-oximetry/Electrolyte/Metabo-<br>lyte Analyzer that is 44cm X 70cm X 50cm (HWD) and weighs 30kg. It<br>measures on whole blood in approximately 60 seconds. |
| INTENDED USE: | The ABL735 is intended for in vitro testing of samples of whole blood for<br>the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride,<br>glucose, lactate, total bilirubin, and co-oximetry parameters (total hemo-<br>globin, oxygen saturation and the hemoglobin fractions FO₂Hb, FCOHb,<br>FMetHb, FHHb, and FHHbF). |
| TECHNOLOGICAL<br>CHARACTERISTICS<br>VERSUS PREDICATE<br>DEVICE: | Similar to the ABL700 Series |
| SUBSTANTIAL<br>EQUIVALENCE: | The ABL735 is substantially equivalent in features and characteristics to<br>the current ABL700 Series (K980130) marketed by Radiometer America<br>Inc. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its wings and head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 4 1999

Mr. Vince Sigmund Manager, Customer Relations/Technical Support Radiometer America, Inc. 810 Sharon Drive Westlake, Ohio 44145

Re: K991417

> Trade Name: ABL735 Analyzer Regulatory Class: II Product Code: CHL, CGZ, JGS, CIG, JFP, CGA, CEM, MQM, CKK Regulatory Class: I Product Code: KHP Dated: October 25, 1999 Received: October 26, 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 (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 Amendnents 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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K991417 510(k) Number (if known):_

Device Name:

Indications For Use:

The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH,p02, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and coloximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions fO2Hb, fCOHb, fHHb, and fHbF)

Jean Cooxn
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 991417

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
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OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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