BIO-CHEM ANALYZER, MODEL 100

K040750 · Clinical Analysis Corporation, Inc. · CEM · Oct 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040750
• Device Name: BIO-CHEM ANALYZER, MODEL 100
• Applicant: Clinical Analysis Corporation, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Oct 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

The CAC Bio-Chem Analyzer™ is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test cartridges for the following test analyte: potassium. Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of conditions characterized by low or high blood potassium levels. The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.

Device Story

Handheld microprocessor-controlled analyzer; measures potassium levels in whole blood or plasma. Uses single-use disposable cartridges containing ion-specific electrodes (ISE) and a calibration solution capsule. Operator applies sample to cartridge; inserts into analyzer. System automatically pumps calibration solution over reference and measuring electrodes; then pumps sample over measuring electrode. Results displayed on analyzer screen. Used in point-of-care settings (hospitals, dialysis clinics, physician offices) by nurses, phlebotomists, or other healthcare professionals. Provides quantitative potassium measurements to assist clinicians in monitoring electrolyte balance and managing disease states related to potassium dysregulation.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on bench-level performance characteristics for a potassium test system.

Technological Characteristics

Microprocessor-controlled benchtop/point-of-care instrument. Utilizes single-use, single-analyte disposable cartridges for potassium measurement. Class II device, product code CEM.

Indications for Use

Indicated for quantitative determination of potassium in whole blood and plasma to monitor electrolyte balance in patients with conditions characterized by hypo- or hyperkalemia. Intended for hospital point-of-care use.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 8 2004

Mr. Charles McBrairty Execututive Vice President R&D Clinical Analysis Corporation 2100 Quaker Pointe Drive Quakertown, PA 18951-2182

k040750 Re:

Trade/Device Name: CAC Bio-Chem Analyzer™ Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM Dated: October 7, 2004 Received: October 8, 2004

Dear Mr. McBrairty:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to ough finding of substantial equivalence of your device to a legally promatication of the results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you dostre specific mission and advertising of your device, please contact the Office of or questions on the promise Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may ookun battle getecturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040750

Device Name: CAC Bio-Chem AnalyzerTM

Indications For Use:

malousono . C. C. C. C. . AnalyzerTM is a microprocessor-controlled rne the blow onem instrument for the quantitative ercermination of specific analytes in whole blood and plasma. deceimination or bposs single-use, single analyte disposable ine instrument deploys books of the following test analyte: potassium

Potassium measurements obtained by this device are used to rocusbram moderalyte balance in the diagnosis and treatment monitir ses conditions characterized by low or high blood potassium levels.

The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic

510(k) k040750

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