TECO ISE REAGENT SET FOR CX SYSTEM

K052724 · Teco Diagnostics · JGS · Dec 14, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052724
• Device Name: TECO ISE REAGENT SET FOR CX SYSTEM
• Applicant: Teco Diagnostics
• Product Code: JGS · Clinical Chemistry
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The ISE Electrolyte Buffer, Electrolyte Reference, CO2 Acid Reagent and CO₂ Alkaline Buffer are intended for use in the determination of sodium, potassium, chloride and carbon dioxide in serum on Beckman SYNCHRON® analyzers.

Device Story

Teco ISE Reagent Set consists of electrolyte buffer, reference reagent, CO2 acid reagent, and CO2 alkaline buffer; used on Beckman CX System analyzers. Device measures ion activity in human serum via ion-selective electrodes (ISE). Sample mixed with high ionic strength buffer to minimize activity coefficient variation; potential generated at electrode surface proportional to analyte concentration (Nernst equation). For CO2, acid reagent releases CO2 from serum; gas diffuses through silicone membrane into alkaline buffer, lowering pH proportional to CO2 concentration. Reagents supplied in 2L and 500ml bottles. Used in clinical laboratory settings by trained personnel. Output provides quantitative electrolyte/CO2 concentrations for clinical decision-making regarding patient metabolic status.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics for in vitro diagnostic use.

Technological Characteristics

Ion-selective electrode (ISE) technology. Reagents: liquid, ready-to-use. Sensing principle: potentiometric measurement of ion activity via glass/validamycin electrodes and silicone membrane for CO2. Connectivity: designed for integration with Beckman CX System analyzers. Storage: room temperature. Shelf life: 18 months (accelerated aging).

Indications for Use

Indicated for quantitative measurement of Sodium, Potassium, Chloride, and Carbon Dioxide in human serum samples to aid in the diagnosis and treatment of electrolyte disorders.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Submission Summary (Full Text)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 4 2005

Mr. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Ave Anaheim. CA 92807

Re:

k052724 Trade/Device Name: Teco ISE Reagent Set for CX System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, CHL, JIX, Dated: November 4, 2005 Received: November 17, 2005

Dear Mr. Vaeches:

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).

{1}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto
Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

## 510(k) Number (if known): Unknown at this time

## Device Name: _ Teco ISE Reagent Set for CX System

Indications For Use: Teco ISE Reagent Set is intended for quantitative measurement of Sodium, Potassium; Chloride and Carbon Dioxide in human serum samples on the Beckman CX System. Teco ISE Reagent Set is used in the diagnosis and treatment electrolyte disorders. ISE Buffer reagent is intended for quantitative measurement of Sodium, Potassium, and Chloride. ISE Reference Reagent is to provide reference points for Sodium, Potassium, and Chloride. The CO2 Acid Reagent is to release Carbon Dioxide from serum samples. The CO2 Buffer Reagent is to provide a reference point for Carbon Dioxide.

This reagent set is intended for in vitro diagnostic use only.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Page 1 of

Hellekson
Division Sign-Off

Office of in Viro Diagnostic Device Evaluation and Safety

65 2724