MULTI-CHEM CALIBRATOR A

K042551 · Wako Chemicals USA, Inc. · JIX · Nov 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042551
• Device Name: MULTI-CHEM CALIBRATOR A
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Multi-Chem Calibrator A is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum.

Device Story

Multi-Chem Calibrator A is a liquid, ready-to-use aqueous solution containing Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium. It serves as a reference material to calibrate clinical chemistry assays for these analytes in human serum. Used in clinical laboratory settings, the calibrator allows healthcare providers to establish reference points for diagnostic testing. By ensuring accurate calibration of Wako assays, the device supports precise quantification of serum analytes, aiding clinicians in diagnosing and monitoring metabolic and mineral-related conditions.

Clinical Evidence

No clinical studies were performed. Substantial equivalence was established through analytical method comparison studies against predicate devices. Correlation coefficients for Calcium, Fe, UIBC, Inorganic Phosphorus, and Magnesium ranged from 0.9990 to 0.9998, with slopes near 1.0, demonstrating analytical performance equivalent to the predicate standards.

Technological Characteristics

Liquid calibrator for in vitro diagnostic use. Designed for use with specific Wako clinical chemistry assays for serum analytes (Calcium, FE, UIBC, Inorganic Phosphorus, Magnesium).

Indications for Use

Indicated for use as a reference standard for the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum samples.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237

NOV 1 6 2004

Re: k042551 Trade/Device Name: Multi-Chem Calibrator A Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 26, 2004 Received: September 21, 2004

Dear Ms. Creasy:

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 his letter will anow you to begin marketing of substantial equivalence of your device to a legally prematication. The PDF interessification 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 destions on the promotion and advertising of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the m Puro Diagins Do Hovending by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oodain other general mormational 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,

Jean 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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K042551 510(k) Number (if known):

Device Name: Multi-Chem Calibrator A

## Indications For Use:

The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.

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)

Carol Benson
Division: Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k: K04255/

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