WAKO CH50 LINEARITY SET

K973055 · Wako Chemicals USA, Inc. · JIW · Sep 25, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973055
• Device Name: WAKO CH50 LINEARITY SET
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIW · Clinical Chemistry
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The CH50 Linearity Set is to be used with WAKO Autokit CH50 test for the estimation of the linearity limits of the reagent/instrument system for the CH50 analyte.

Device Story

The CH50 Linearity Set is an in vitro diagnostic product used to verify the performance and linearity limits of the WAKO Autokit CH50 test system. It serves as a quality control tool for laboratory professionals to ensure the accuracy of CH50 analyte measurements across the instrument's analytical range. By testing the linearity set, clinicians can confirm that the reagent/instrument system is operating within specified parameters, thereby supporting reliable clinical decision-making regarding complement activity. The device is intended for professional use in clinical laboratories.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent set designed for linearity verification of the CH50 analyte assay. The device functions as a calibration/verification standard for use with the WAKO Autokit CH50 test system.

Indications for Use

Indicated for use with the WAKO Autokit CH50 test to estimate the linearity limits of the reagent/instrument system for the CH50 analyte in a clinical laboratory setting.

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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SEP 2 5 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tonya Mallory Manaqer Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237

Re : K973055 Wako CH50 Linearity Set Trade Name: Regulatory Class: II Product Code: JIW Dated: August 11, 1997 Received: Auqust 15, 1997

Dear Ms. Mallory:

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 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 aqainst 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 requirement, 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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Paqe 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 requlation (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" (21 CFR 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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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Page 1 of 1_

510(k) Number (if known):__K973055

CH50 LINEARITY SET WAKO Device Name:

## Indications For Use:

The CH50 Linearity Set is to be used with WAKO Autokit CH50 test for the estimation of the linearity limits of the reagent/instrument system for the CH50 analyte.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roc E. Madani
Division Sign Off

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number

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

OR

(Optional Format 1-2-96)

Over-The-Counter Use_