ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM

K980130 · Radiometer America, Inc. · CHL · Feb 9, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980130
• Device Name: ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
• Applicant: Radiometer America, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Feb 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa+, cCl-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.

Device Story

ABL700 Series is an automated, stand-alone benchtop analyzer for blood gas, co-oximetry, electrolyte, and metabolite analysis. It processes human arterial, venous, and capillary whole blood samples, as well as expired air. The device measures pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate. Operation is performed by clinical laboratory personnel. The system provides rapid results (approximately 60 seconds) to assist clinicians in assessing patient acid-base status, oxygenation, and metabolic state. It serves as a diagnostic tool in clinical settings to guide immediate medical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated benchtop analyzer (44 cm x 70 cm x 50 cm; 30 kg). Measures pH, blood gases, electrolytes, metabolites, and co-oximetry parameters. Stand-alone system. Technological characteristics are similar to predicate ABL625 and ABL555 devices.

Indications for Use

Indicated for the measurement of pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-), metabolites (Glucose, Lactate), and co-oximetry parameters in human arterial, venous, and capillary whole blood, and pO2/pCO2 in expired air.

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

• ABL625 (K962334)
• ABL555 (K973367)

Submission Summary (Full Text)

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# RADIOMETER AMERICA INC.

MEDICAL DIVISION

- 1998

EXHIBIT VI

811 SHARON DRIVE, WESTLAKE, OHIO 44145-1688 800-736-0600, 218-871-8

#### 510(k) SUMMARY SUBJECT:

- FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145 [phone], Ext. 287 or 1-800-736-0600 Fax [phone]
- January 5, 1998 DATE:
- Trade Name: ABL700 Series PRODUCT: Common Name: Blood Gas, Co-oximetry, Electrolyte and Metabolite Measuring System Classification Name: Blood Gas

### PREDICATE

ABL625 and ABL555 DEVICE:

#### PRODUCT

- DESCRIPTION: ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.
### INTENDED

- ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, USE: pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.
## TECHNOLOGICAL CHARACTERISTICS

#### VERSUS PREDICATE

ABL700 Series is technologically similar to the ABL625 and ABL555. DEVICE:

#### SUBSTANTIAL EQUIVALENCE:

ABL700 Series is substantially equivalent in features and characteristics to the current ABL625 (K962334) and ABL555 (K973367) marketed by Radiometer America 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 stylized eagle with three tail feathers, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 9 1008

Donald L. Baker · Director of Marketing and Regulatory Affairs Radiometer America, Inc. 811 Sharon Drive Westlake, Ohio 44145-1598

Re : K980130 ABL700 Series Analyzer Regulatory Class: I & II Product Code: CHL, JFP, CGZ, CGA, KHP, CEM, JGS January 5, 1997 Dated: January 14, 1997 Received:

Dear Mr. Baker:

regulations.

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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (Size Co), Child Concernine 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 acious in your may 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/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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# EXHIBIT V

510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, p02 , cNat, cK+, cCa+, cCL, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.

P. Bierhaus (Lois A. Montgomery)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980130

(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)

Over-The-Counter-Use (Optional Format 1-2-96)