ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

K994346 · Sendx Medical, Inc. · CHL · Feb 1, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994346
• Device Name: ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
• Applicant: Sendx Medical, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Feb 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.

Device Story

ABL 77 is an automated diagnostic system for measuring blood gases, electrolytes, and hematocrit; inputs are arterial or venous whole blood samples; device performs electrochemical and conductometric analysis to quantify pH, pO2, pCO2, Na+, K+, Cl-, Ca++, and hematocrit; used in clinical laboratories, near-patient, or point-of-care settings by healthcare professionals; output provides quantitative diagnostic data to clinicians for patient assessment and clinical decision-making; system facilitates rapid diagnostic testing to support patient management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

System utilizes electrochemical and conductometric sensing principles for blood gas, electrolyte, and hematocrit analysis; designed for point-of-care and laboratory use; device performs automated measurement of whole blood samples.

Indications for Use

Indicated for the measurement of blood gases (oxygen, carbon dioxide, pH), electrolytes (sodium, potassium, chloride, ionized calcium), and hematocrit in arterial and venous whole blood samples for patients requiring clinical laboratory analysis in laboratory, near-patient, or point-of-care 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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 2000 FEB

Mr. Martin R. Sellers Director of Regulatory Affairs and Quality Assurance SenDx Medical Inc. 1945 Palomar Oaks Way Carlsbad, California 92009

- Re: K994346
Trade Name: ABL 77 pH, Blood Gas and Electrolyte Analysis System Regulatory Class: II Product Code: CHL Dated: December 20, 1999 Received: December 23, 1999

Dear Mr. Sellers:

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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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" (21CFR 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 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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## 10. Indications for Use Form

510(k) Pre-Market Notification ABL 77 pH, Blood Gas and Electrolyte Analysis System

510(k) Number (TBD) K 99 4346

Device Name: ABL 77 pH, Blood Gas and Electrolyte Analysis System

The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED,

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Bernalcot for M.J. Cooper
(Division Sign-Off)
Division of Laboratory Devices

510(k) Nun.

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

or

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