ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM

K973367 · Radiometer America, Inc. · CHL · Oct 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973367
• Device Name: ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
• Applicant: Radiometer America, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Oct 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, and glucose on whole blood.

Device Story

ABL555 is an automated, standalone benchtop analyzer (40x55x40 cm; 37.5 kg) for clinical laboratory use. It processes whole blood samples to measure pH, pCO2, pO2, Na+, K+, and glucose. Analysis completes in approximately 54 seconds. The device provides quantitative results to clinicians to assist in patient assessment and clinical decision-making regarding blood gas, electrolyte, and metabolite status.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing comparisons to the predicate device.

Technological Characteristics

Automated blood gas, electrolyte, and metabolite analyzer. Measures pH, pCO2, pO2, Na+, K+, and glucose via electrochemical sensors. Dimensions: 40 cm x 55 cm x 40 cm. Weight: 37.5 kg. Standalone operation.

Indications for Use

Indicated for the measurement of pH, pCO2, pO2, Na+, K+, and glucose in whole blood samples.

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

• ABL505 (K914166)
• EML105

Submission Summary (Full Text)

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NHI 55001

# RADIOMETER AMERICA INC.

MEDICAL DIVISION

EXHIBIT VI

811 SHARON DRIVE, WESTLAKE, OHIO 44146-1508 800-736-0600, 216-871-8900 FAX [phone]

OCT - 6 1997

#### SUBJECT: 510(k) SUMMARY

- 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]
- DATE: September 5, 1997
- PRODUCT: Trade Name - ABL555 Common Name -Blood Gas, Electrolyte and Metabolite Measuring System Classification Name - Blood Gas

#### PREDICATE

DEVICE: ABL505 and EML105

#### PRODUCT

ः ।

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

- DESCRIPTION: ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.
### INTENDED

- USE: ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, and glucose on whole blood.
## TECHNOLOGICAL CHARACTERISTICS

#### VERSUS PREDICATE

DEVICE: ABL555 (with glucose) is technologically similar to the current version ABL505.

#### SUBSTANTIAL EQUIVALENCE:

ABL555 is substantially equivalent in features and characteristics to the current ABL505 marketed by Radiometer America Inc. (K914166). The major difference is the addition of the glucose analyte and the elimination of the Ca and CI electrodes.

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0CT - 6 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K973367 ABL555 Analyzer Requlatory Class: II Product Code: CHL, JGS, CEM, CGA September 5, 1997 Dated: Received: September 8, 1997

Dear Mr. Baker:

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 Regulations, Title 21, Parts 800 to 895. ਕੇ 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 requlation (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 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 regulations.

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Paqe 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 requlation (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 one regulation entification" (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 Pitman

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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Page_ of

10(k) Number (if known):

ABL5555 Device Name:_

ndications For Use:

ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, a
nd alone, the contract and the blood ABL555 is a stand alone, blood glucose on whole blood.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 2923367

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)