CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

K090283 · Genchem, Inc. · JIX · Jun 5, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090283
• Device Name: CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
• Applicant: Genchem, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2

Device Story

SYNCHRON CX Multi-Analyte Mixture consists of three levels of ready-to-use aqueous calibrators containing synthetic inorganic chemicals. Used with Beckman SYNCHRON CX Systems to establish reference points for quantitative in vitro diagnostic testing of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2. Calibrators are non-blood based. Healthcare providers use the system output to ensure accurate calibration of clinical chemistry analyzers, facilitating reliable patient test results for metabolic and electrolyte monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed shelf life and 30-day open-vial stability at 2-8°C. Value assignment performed via gravimetric addition and verified using two analyzers with 3 runs and 3 replicates per level, ensuring results remain within ±2SD of assigned values and Beckman Coulter specifications.

Technological Characteristics

Liquid multi-analyte mixture containing sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2. Designed for use with Beckman SYNCHRON CX systems. No software or electronic components.

Indications for Use

Indicated for use as a calibration tool for Beckman SYNCHRON CX systems to enable quantitative measurement of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2 in clinical laboratory settings.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Genchem, Inc. c/o James M. Henneman 510 West Central Avenue Suite D Brea, CA 92821

JUN - 5 2009

Re: k090283

> Trade/Device Name: SYNCHRON CZ Multi-Analyte Mixture Calibrators 1,2, and, 3 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrators, Multi-Analyte Mixture Regulatory Class: Class II Product Code: JIX Dated: May 14, 2009 Received: May 18, 2009

Dear Mr. Henneman:

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) 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), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

A. C. H.

Courtney C. Harper, Ph.D. Acting 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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## Indication for Use

510(k) Number (if known): k090283

Device Name: SYNCHRON CX Multi-Analyte Mixture Calibrators 1, 2, and 3

Indication For Use:

SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2

Prescription Use V (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090283